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A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler in Adolescents and Adults Who Have Asthma That is Not Controlled by Asthma Medications Not Containing Steroids

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Fp MDPI
Flovent Diskus
albuterol/salbutamol
Placebo MDPI
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Dose Ranging, Fluticasone Propionate, Dry Powder Inhaler (DPI), Non-steroidal, Asthma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Written informed consent/assent signed and dated by the subject and/or parent /legal guardian before conducting any study related procedure.
  2. Male or female 12 years and older, as of the Screening Visit. Male or female 18 years and older, as of the Screening Visit, in countries where local regulations or the regulatory status of study medication permit enrollment of adults only.
  3. General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the study.
  4. Asthma Diagnosis: Asthma as defined by the National Institutes of Health (NIH).
  5. Severity of Disease: A best forced expiratory volume in one second (FEV1) of 40%-85% of the predicted normal value during the Screening Visit. NHANES III predicted values will be used for subjects aged ≥12 years and adjustments to predicted values will be made for African American subjects.
  6. Reversibility of Disease: Demonstrated a ≥15% reversibility of FEV1 within 30 minutes following 2 inhalations of albuterol/salbutamol inhalation aerosol (if required, spacers are permitted for reversibility testing only) at the Screening Visit. If a subject fails to demonstrate an increase in FEV1 ≥15%, then the subject is not eligible for the study and will not be allowed to re-screen.
  7. Current Asthma Therapy: Subjects must be on a short-acting β2-agonist alone or a non-corticosteroid maintenance medication (with or without a short-acting β2-agonist) for ≥ 3 months preceding the Screening Visit. Subjects must not have used an inhaled corticosteroid for at least 6 weeks preceding the Screening Visit.

    Exception: Based upon the investigator's judgment that there is no inherent harm in changing the subject's current ICS therapy and the subject provides consent, subjects on low dose ICS (100mcg Fp BID or equivalent) may be switched to a short-acting β2 agonist alone at a Pre-screening Visit. The subject will be required to return to the clinic to complete the Screening Visit once the 2-week washout period has been completed.

  8. Short-Acting β2-Agonists: All subjects must be able to replace their current short-acting β2-agonists with albuterol/salbutamol inhalation aerosol at the Screening Visit for use as needed for the duration of the study. The use of spacer devices with the metered dose inhaler (MDI) will not be allowed during the study with exception of its use during reversibility testing at the Screening Visit. Nebulized albuterol/salbutamol will not be allowed at any time during the study. Subjects must be able to withhold all inhaled short-acting beta sympathomimetic bronchodilators for at least 6 hours prior to all study visits.
  9. If female, is currently not pregnant, breast feeding, or attempting to become pregnant, has a negative serum pregnancy test, and is of

    1. Non-childbearing potential, defined as:

      • Before menarche or > or =1 year post-menopausal or
      • Surgically sterile (tubal ligation, bilateral oophorectomy, or hysterectomy) or
      • Congenital sterility or
      • Diagnosed as infertile and not undergoing treatment to reverse infertility or is of
    2. Child-bearing potential, willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study:

      • Systemic contraception used for > or = 1 month prior to screening, including birth control pills, transdermal patch (Ortho Evra®), vaginal ring (NuvaRing®), levonorgesterel (Norplant®), or injectable progesterone (Depo-Provera®) or
      • Double barrier methods (condoms, cervical cap, diaphragm, and vaginal contraceptive film with spermicide) or
      • Intrauterine device (IUD) or is of
    3. Child-bearing potential and not sexually active, willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study, in the event the subject becomes sexually active.
  10. Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements (visits, record-keeping, etc).

Exclusion Criteria:

  1. History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
  2. Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks prior to the Screening Visit. In addition, the subject must be excluded if such infection occurs between the Screening Visit and the Randomization Visit.
  3. Any asthma exacerbation requiring oral corticosteroids within 3 months of the Screening Visit. A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit.

    Note: An exacerbation of asthma is defined as any worsening of asthma requiring any treatment other than rescue albuterol/salbutamol HFA MDI and/or the subject's regular non-corticosteroid maintenance treatment. This includes requiring the use of systemic corticosteroids and/or emergency room visit or hospitalization, a change in the subject's regular non-corticosteroid maintenance treatment, or the addition of other asthma medications.

  4. Presence of glaucoma, cataracts, ocular herpes simplex, or malignancy other than basal cell carcinoma.
  5. Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (e.g., congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (e.g., uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), gastrointestinal (e.g., poorly-controlled peptic ulcer, GERD), or pulmonary (e.g., chronic bronchitis, emphysema, bronchiectasis with the need for treatment, cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
  6. Have any of the following conditions that, in the judgment of the investigator, might cause participation in this study to be detrimental to the subject, including, but not limited to:

    • Current malignancy excluding basal cell carcinoma; History of malignancy is acceptable only if the subject has been in remission for one year prior to the Screening Visit. (Remission is defined as no current evidence of malignancy and no treatment for the malignancy in the 12 months prior to the Screening Visit)
    • Current or untreated tuberculosis; History of tuberculosis is acceptable only if a subject has received an approved prophylactic treatment regimen or an approved active treatment regimen and has had no evidence of active disease for a minimum of 2 years • Uncontrolled hypertension (systolic BP ≥160 or diastolic BP >100)
    • Stroke within 3 months prior to the Screening Visit
    • Immunologic compromise
  7. History of a positive test for HIV, hepatitis B or hepatitis C infection.
  8. Clinical visual evidence of oral candidiasis at the Screening Visit.
  9. History of any adverse reaction, including immediate or delayed hypersensitivity to any β2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the dry powder inhalers (Spiromax or Diskus) used in the study (i.e., lactose).
  10. History of severe allergy to milk protein.
  11. Use of systemic, oral or depot corticosteroids within 12 weeks prior to the Screening Visit

    • Use of topical corticosteroids (≤1% hydrocortisone cream) for dermatological disease is permitted
    • Use of intranasal corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit and throughout the study is permitted
  12. Use of immunosuppressive medications within 4 weeks prior to the Screening Visit and during the study.
  13. Immunotherapy at a stable dose for at least 90 days prior to the Screening Visit and throughout the study for the treatment of allergies is permitted.
  14. Use of potent Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole, itraconazole) within 4 weeks prior to the Screening Visit.
  15. History of alcohol or drug abuse within two years preceding the Screening Visit.
  16. Current smoker or a smoking history of 10 pack years or more (a pack year is defined as smoking 1 pack of cigarettes/day for 1 year). A subject may not have used tobacco products within the past one year (e.g., cigarettes, cigars, chewing tobacco, or pipe tobacco).
  17. Study participation by clinical investigator site employees and/or their immediate relatives.
  18. Study participation by more than one subject from the same household at the same time. However, after the study completion or discontinuation by one subject another subject from the same household may be screened.
  19. Participation in any investigational drug study within the 30 days (starting at the final follow-up visit) preceding the Screening Visit or planned participation in another investigational drug study at any time during this study.
  20. Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the subject's last study related visit (for eligible subjects only - if applicable). Eligible female subjects unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded.

Sites / Locations

  • Teva Investigational Site 10165
  • Teva Investigational Site 11142
  • Teva Investigational Site 10104
  • Teva Investigational Site 11149
  • Teva Investigational Site 10173
  • Teva Investigational Site 10163
  • Teva Investigational Site 10156
  • Teva Investigational Site 11101
  • Teva Investigational Site 11111
  • Teva Investigational Site 10151
  • Teva Investigational Site 10157
  • Teva Investigational Site 10176
  • Teva Investigational Site 10147
  • Teva Investigational Site 11110
  • Teva Investigational Site 10136
  • Teva Investigational Site 11122
  • Teva Investigational Site 10140
  • Teva Investigational Site 10197
  • Teva Investigational Site 10185
  • Teva Investigational Site 10143
  • Teva Investigational Site 11137
  • Teva Investigational Site 10130
  • Teva Investigational Site 10182
  • Teva Investigational Site 10179
  • Teva Investigational Site 10106
  • Teva Investigational Site 10129
  • Teva Investigational Site 10145
  • Teva Investigational Site 10172
  • Teva Investigational Site 10133
  • Teva Investigational Site 10154
  • Teva Investigational Site 11146
  • Teva Investigational Site 10128
  • Teva Investigational Site 10196
  • Teva Investigational Site 10191
  • Teva Investigational Site 11127
  • Teva Investigational Site 11118
  • Teva Investigational Site 11141
  • Teva Investigational Site 11140
  • Teva Investigational Site 10137
  • Teva Investigational Site 10153
  • Teva Investigational Site 11120
  • Teva Investigational Site 11128
  • Teva Investigational Site 11132
  • Teva Investigational Site 11145
  • Teva Investigational Site 10171
  • Teva Investigational Site 10178
  • Teva Investigational Site 11103
  • Teva Investigational Site 10161
  • Teva Investigational Site 10139
  • Teva Investigational Site 11114
  • Teva Investigational Site 10111
  • Teva Investigational Site 11124
  • Teva Investigational Site 10180
  • Teva Investigational Site 10168
  • Teva Investigational Site 11109
  • Teva Investigational Site 10116
  • Teva Investigational Site 10127
  • Teva Investigational Site 10184
  • Teva Investigational Site 10113
  • Teva Investigational Site 10164
  • Teva Investigational Site 10158
  • Teva Investigational Site 10110
  • Teva Investigational Site 10177
  • Teva Investigational Site 10138
  • Teva Investigational Site 10146
  • Teva Investigational Site 10131
  • Teva Investigational Site 10175
  • Teva Investigational Site 10189
  • Teva Investigational Site 11147
  • Teva Investigational Site 10118
  • Teva Investigational Site 10150
  • Teva Investigational Site 11144
  • Teva Investigational Site 11136
  • Teva Investigational Site 10114
  • Teva Investigational Site 10193
  • Teva Investigational Site 10101
  • Teva Investigational Site 10155
  • Teva Investigational Site 10188
  • Teva Investigational Site 11113
  • Teva Investigational Site 10187
  • Teva Investigational Site 10120
  • Teva Investigational Site 10190
  • Teva Investigational Site 10167
  • Teva Investigational Site 10112
  • Teva Investigational Site 10105
  • Teva Investigational Site 10122
  • Teva Investigational Site 10194
  • Teva Investigational Site 10107
  • Teva Investigational Site 10123
  • Teva Investigational Site 10144
  • Teva Investigational Site 11135
  • Teva Investigational Site 11115
  • Teva Investigational Site 10160
  • Teva Investigational Site 10174
  • Teva Investigational Site 10198
  • Teva Investigational Site 11108
  • Teva Investigational Site 10132
  • Teva Investigational Site 10135
  • Teva Investigational Site 10142
  • Teva Investigational Site 11104
  • Teva Investigational Site 10183
  • Teva Investigational Site 10166
  • Teva Investigational Site 10121
  • Teva Investigational Site 11119
  • Teva Investigational Site 10181
  • Teva Investigational Site 10162
  • Teva Investigational Site 10126
  • Teva Investigational Site 10149
  • Teva Investigational Site 10199
  • Teva Investigational Site 11131
  • Teva Investigational Site 10119
  • Teva Investigational Site 10141
  • Teva Investigational Site 10192
  • Teva Investigational Site 10148
  • Teva Investigational Site 10115
  • Teva Investigational Site 11133
  • Teva Investigational Site 11134
  • Teva Investigational Site 10103
  • Teva Investigational Site 11143
  • Teva Investigational Site 10195
  • Teva Investigational Site 10134
  • Teva Investigational Site 10159
  • Teva Investigational Site 10102
  • Teva Investigational Site 11105
  • Teva Investigational Site 10108
  • Teva Investigational Site 10124
  • Teva Investigational Site 11117
  • Teva Investigational Site 11125
  • Teva Investigational Site 10170
  • Teva Investigational Site 59107
  • Teva Investigational Site 59103
  • Teva Investigational Site 59106
  • Teva Investigational Site 59104
  • Teva Investigational Site 59101
  • Teva Investigational Site 59102
  • Teva Investigational Site 59105
  • Teva Investigational Site 85105
  • Teva Investigational Site 85102
  • Teva Investigational Site 85103
  • Teva Investigational Site 85104
  • Teva Investigational Site 36107
  • Teva Investigational Site 36104
  • Teva Investigational Site 36105
  • Teva Investigational Site 36113
  • Teva Investigational Site 36103
  • Teva Investigational Site 36108
  • Teva Investigational Site 36102
  • Teva Investigational Site 36106
  • Teva Investigational Site 36109
  • Teva Investigational Site 36101
  • Teva Investigational Site 36111
  • Teva Investigational Site 72111
  • Teva Investigational Site 72101
  • Teva Investigational Site 72102
  • Teva Investigational Site 72104
  • Teva Investigational Site 72109
  • Teva Investigational Site 72106
  • Teva Investigational Site 72107
  • Teva Investigational Site 72103
  • Teva Investigational Site 72110
  • Teva Investigational Site 72108
  • Teva Investigational Site 48107
  • Teva Investigational Site 48105
  • Teva Investigational Site 48106
  • Teva Investigational Site 48101
  • Teva Investigational Site 48108
  • Teva Investigational Site 48103
  • Teva Investigational Site 48104
  • Teva Investigational Site 81101
  • Teva Investigational Site 81102
  • Teva Investigational Site 34101
  • Teva Investigational Site 34102
  • Teva Investigational Site 34103
  • Teva Investigational Site 80101
  • Teva Investigational Site 80113
  • Teva Investigational Site 80111
  • Teva Investigational Site 80103
  • Teva Investigational Site 80117
  • Teva Investigational Site 80104
  • Teva Investigational Site 80105
  • Teva Investigational Site 80106
  • Teva Investigational Site 80107
  • Teva Investigational Site 80108
  • Teva Investigational Site 80109
  • Teva Investigational Site 80114
  • Teva Investigational Site 80118
  • Teva Investigational Site 80112
  • Teva Investigational Site 80115
  • Teva Investigational Site 80110

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Fp MDPI 12.5 mcg

Fp MDPI 25 mcg

Fp MDPI 50 mcg

Fp MDPI 100 mcg

Placebo MDPI

Flovent Diskus 100mcg

Arm Description

Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.

Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.

Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.

Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.

Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.

Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.

Outcomes

Primary Outcome Measures

Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period
Trough FEV1 was measured electronically by spirometry at morning (AM) investigational site visits, before administration of the AM dose of study drug and before albuterol/salbutamol administration. The highest FEV1 value from 3 acceptable and 2 reproducible maneuvers was used. All FEV1 data were submitted to a central reading center for evaluation. The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline FEV1 + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed.

Secondary Outcome Measures

Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period
Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device. On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit. Baseline trough AM PEF was defined as the average of recorded (non-missing) trough AM PEF assessments over the 7 days directly preceding first study drug intake. The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed.
Change From Baseline In Weekly Average Of Daily Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period
Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device. PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake. The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed.
Change From Baseline in the Percentage of Rescue-Free 24-hour Periods During the 12-Week Treatment Period
The number of inhalations of rescue medication used each day and each night was recorded in the subject's diary device. Change from baseline in the percentage of rescue-free 24-hour periods was analyzed with a marginal (also called population averaged) logistic model. The model included 2 time points of measurement for each subject: the baseline and the treatment period. The model contained covariates for sex, age, and treatment. The model for the 2 time points was considered as an incomplete randomized block model, with each subject as a block, receiving the baseline level in 1 sub-block and either active treatment or placebo in the other sub-block. The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. Measure type are estimated mean and measure of dispersion is the standard error of the estimated mean.
Kaplan-Meier Estimate of Probability of Remaining in the Study at Week 12
The time to withdrawal due to stopping criteria was compared between the treatment groups with the log rank test. The Kaplan-Meier estimate of the probability of remaining in the study at week 12 with 95% CI was presented by treatment group. Subjects who completed the study were censored at the date of completion, subjects who withdrew for reasons other than stopping criteria were censored at the time of withdrawal. Stopping criteria were based on day subject first met stopping criteria, using subject's diary data and asthma exacerbations recorded in CRF.
Area Under The Curve From Time 0 Until The Last Measurable Concentration (AUC0-t) of Fp
Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments.
Maximum Observed Plasma Concentration (Cmax) of Fp
Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments.
Time of Maximum Concentration (Tmax) of Fp
Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments.
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Oropharyngeal Exam Findings at Each Study Visit
Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at all study visits. If the visual oropharyngeal examination was abnormal at the screening visit, the subject was excluded from entering the study and subjects with an abnormal oropharyngeal exam on Day 1 were not eligible for randomization. Any visual evidence of oral candidiasis during the treatment period of the study was evaluated by obtaining and analyzing a swab of the suspect area. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation. Subjects with a culture-positive infection could continue participation in the study on appropriate anti-infective therapy, provided this therapy was not prohibited by the protocol. If a subject required a protocol-prohibited medication for therapy, the subject was to be discontinued from the study. Data format: Time frame, <signs of oral candidiasis?> yes or no

Full Information

First Posted
November 22, 2011
Last Updated
May 2, 2017
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Collaborators
PPD
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1. Study Identification

Unique Protocol Identification Number
NCT01479621
Brief Title
A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler in Adolescents and Adults Who Have Asthma That is Not Controlled by Asthma Medications Not Containing Steroids
Official Title
A 12-Week Dose-ranging Study to Evaluate the Efficacy and Safety of Fluticasone Propionate DPI Administered Twice Daily Compared With Placebo in Adolescent and Adult Subjects With Persistent Asthma Uncontrolled on Non-steroidal Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Collaborators
PPD

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized, double-blind, placebo- and open-label active controlled, parallel-group, multicenter, dose ranging study in male or female subjects ages 12 years and older with persistent asthma who are uncontrolled on non-steroidal therapy. The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate delivered as Fluticasone Propionate DPI (Dry Powder Inhaler) when administered twice daily.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Dose Ranging, Fluticasone Propionate, Dry Powder Inhaler (DPI), Non-steroidal, Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
909 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fp MDPI 12.5 mcg
Arm Type
Experimental
Arm Description
Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Arm Title
Fp MDPI 25 mcg
Arm Type
Experimental
Arm Description
Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Arm Title
Fp MDPI 50 mcg
Arm Type
Experimental
Arm Description
Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Arm Title
Fp MDPI 100 mcg
Arm Type
Experimental
Arm Description
Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Arm Title
Placebo MDPI
Arm Type
Experimental
Arm Description
Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Arm Title
Flovent Diskus 100mcg
Arm Type
Experimental
Arm Description
Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
Intervention Type
Drug
Intervention Name(s)
Fp MDPI
Other Intervention Name(s)
Fluticasone propionate, Fp SPIROMAX® Inhalation Powder
Intervention Description
Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened. During the treatment period, participants were randomized to 12.5, 25, 50 or 100 mcg of Fp one inhalation twice a day for a total daily dose of 25, 50, 100 or 200 mcg. Study drug was administered in the morning and in the evening
Intervention Type
Drug
Intervention Name(s)
Flovent Diskus
Other Intervention Name(s)
Fluticasone propionate
Intervention Description
Flovent Diskus contains the active ingredient fluticasone propionate (Fp). Flovent Diskus 100 mcg was used twice a day, once in the morning and evening, for a total daily dose of 200 mcg of Fp. This therapy was not blinded as the inhaler device was different than the MDPI used in the other treatment arms.
Intervention Type
Drug
Intervention Name(s)
albuterol/salbutamol
Other Intervention Name(s)
short-acting β2-adrenergic agonists
Intervention Description
A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).
Intervention Type
Drug
Intervention Name(s)
Placebo MDPI
Intervention Description
Placebo multidose dry powder inhaler in the morning and evening. Placebo MDPI was provided in devices identical in appearance to Fp MDPI.
Primary Outcome Measure Information:
Title
Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period
Description
Trough FEV1 was measured electronically by spirometry at morning (AM) investigational site visits, before administration of the AM dose of study drug and before albuterol/salbutamol administration. The highest FEV1 value from 3 acceptable and 2 reproducible maneuvers was used. All FEV1 data were submitted to a central reading center for evaluation. The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline FEV1 + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed.
Time Frame
Baseline (Day 1, pre-dose), During Study (Days 7, 14, 28, 56 and 84 pre-dose)
Secondary Outcome Measure Information:
Title
Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period
Description
Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device. On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit. Baseline trough AM PEF was defined as the average of recorded (non-missing) trough AM PEF assessments over the 7 days directly preceding first study drug intake. The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed.
Time Frame
Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)
Title
Change From Baseline In Weekly Average Of Daily Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period
Description
Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device. PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake. The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed.
Time Frame
Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)
Title
Change From Baseline in the Percentage of Rescue-Free 24-hour Periods During the 12-Week Treatment Period
Description
The number of inhalations of rescue medication used each day and each night was recorded in the subject's diary device. Change from baseline in the percentage of rescue-free 24-hour periods was analyzed with a marginal (also called population averaged) logistic model. The model included 2 time points of measurement for each subject: the baseline and the treatment period. The model contained covariates for sex, age, and treatment. The model for the 2 time points was considered as an incomplete randomized block model, with each subject as a block, receiving the baseline level in 1 sub-block and either active treatment or placebo in the other sub-block. The generalized estimating equation (GEE) algorithm was used to fit the model, using a robust estimator for the variance which provided a proper adjustment for possible correlation between the 2 measurements on each subject. Measure type are estimated mean and measure of dispersion is the standard error of the estimated mean.
Time Frame
Baseline (Days -7 to -1), During Study (Days 1-84)
Title
Kaplan-Meier Estimate of Probability of Remaining in the Study at Week 12
Description
The time to withdrawal due to stopping criteria was compared between the treatment groups with the log rank test. The Kaplan-Meier estimate of the probability of remaining in the study at week 12 with 95% CI was presented by treatment group. Subjects who completed the study were censored at the date of completion, subjects who withdrew for reasons other than stopping criteria were censored at the time of withdrawal. Stopping criteria were based on day subject first met stopping criteria, using subject's diary data and asthma exacerbations recorded in CRF.
Time Frame
Day 1 to Day 84
Title
Area Under The Curve From Time 0 Until The Last Measurable Concentration (AUC0-t) of Fp
Description
Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments.
Time Frame
Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose
Title
Maximum Observed Plasma Concentration (Cmax) of Fp
Description
Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments.
Time Frame
Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose
Title
Time of Maximum Concentration (Tmax) of Fp
Description
Approximately 20% of subjects randomized to the study and distributed across preselected study sites were to participate in fluticasone propionate pharmacokinetic assessments (the pharmacokinetic cohort). Subjects who had received fluticasone propionate in any form (orally, inhaled, or nasal) within 14 days of Day 1 were not permitted to participate in pharmacokinetic assessments.
Time Frame
Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose
Title
Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
Description
An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Time Frame
Day 1 -84
Title
Oropharyngeal Exam Findings at Each Study Visit
Description
Oropharyngeal examinations for visual evidence of oral candidiasis were conducted at all study visits. If the visual oropharyngeal examination was abnormal at the screening visit, the subject was excluded from entering the study and subjects with an abnormal oropharyngeal exam on Day 1 were not eligible for randomization. Any visual evidence of oral candidiasis during the treatment period of the study was evaluated by obtaining and analyzing a swab of the suspect area. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation. Subjects with a culture-positive infection could continue participation in the study on appropriate anti-infective therapy, provided this therapy was not prohibited by the protocol. If a subject required a protocol-prohibited medication for therapy, the subject was to be discontinued from the study. Data format: Time frame, <signs of oral candidiasis?> yes or no
Time Frame
Screening (week -3 to -2), Baseline (Week 0), Weeks 1, 2, 4, 8, 12
Other Pre-specified Outcome Measures:
Title
Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data
Description
Trough FEV1 was measured electronically by spirometry at morning (AM) investigational site visits, before administration of the AM dose of study drug and before albuterol/salbutamol administration. The highest FEV1 value from 3 acceptable and 2 reproducible maneuvers was used. All FEV1 data were submitted to a central reading center for evaluation. The p-values for the treatment comparisons to placebo are from an MMRM model including data from all treatments: change from baseline = baseline FEV1 + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed.
Time Frame
Baseline (Day 1, pre-dose), During Study (Days 7, 14, 28, 56 and 84 pre-dose)
Title
Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data
Description
Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device. On mornings for which a treatment visit was scheduled (TV1 through TV9), the PEF was measured and recorded at the investigational site visit. Baseline trough AM PEF was defined as the average of recorded (non-missing) trough AM PEF assessments over the 7 days directly preceding first study drug intake. The p-values for the treatment comparisons to placebo are from an MMRM model including all treatments: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed.
Time Frame
Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)
Title
Change From Baseline In Weekly Average Of Daily Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data
Description
Peak expiratory flow was determined in the AM and in the PM, before administration of study or rescue medications using a handheld electronic peak flow meter. The highest value of triplicate measurements obtained was recorded by the subject's diary device. PM PEF baseline was defined as the average of recorded (nonmissing) PM PEF assessments over the 7 days directly preceding first study drug intake. The p-values for the treatment comparisons to placebo are from an MMRM model including all treatment groups: change from baseline = baseline PEF + sex + age + treatment + visit + treatment*visit with an unstructured covariance matrix assumed.
Time Frame
Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent/assent signed and dated by the subject and/or parent /legal guardian before conducting any study related procedure. Male or female 12 years and older, as of the Screening Visit. Male or female 18 years and older, as of the Screening Visit, in countries where local regulations or the regulatory status of study medication permit enrollment of adults only. General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the study. Asthma Diagnosis: Asthma as defined by the National Institutes of Health (NIH). Severity of Disease: A best forced expiratory volume in one second (FEV1) of 40%-85% of the predicted normal value during the Screening Visit. NHANES III predicted values will be used for subjects aged ≥12 years and adjustments to predicted values will be made for African American subjects. Reversibility of Disease: Demonstrated a ≥15% reversibility of FEV1 within 30 minutes following 2 inhalations of albuterol/salbutamol inhalation aerosol (if required, spacers are permitted for reversibility testing only) at the Screening Visit. If a subject fails to demonstrate an increase in FEV1 ≥15%, then the subject is not eligible for the study and will not be allowed to re-screen. Current Asthma Therapy: Subjects must be on a short-acting β2-agonist alone or a non-corticosteroid maintenance medication (with or without a short-acting β2-agonist) for ≥ 3 months preceding the Screening Visit. Subjects must not have used an inhaled corticosteroid for at least 6 weeks preceding the Screening Visit. Exception: Based upon the investigator's judgment that there is no inherent harm in changing the subject's current ICS therapy and the subject provides consent, subjects on low dose ICS (100mcg Fp BID or equivalent) may be switched to a short-acting β2 agonist alone at a Pre-screening Visit. The subject will be required to return to the clinic to complete the Screening Visit once the 2-week washout period has been completed. Short-Acting β2-Agonists: All subjects must be able to replace their current short-acting β2-agonists with albuterol/salbutamol inhalation aerosol at the Screening Visit for use as needed for the duration of the study. The use of spacer devices with the metered dose inhaler (MDI) will not be allowed during the study with exception of its use during reversibility testing at the Screening Visit. Nebulized albuterol/salbutamol will not be allowed at any time during the study. Subjects must be able to withhold all inhaled short-acting beta sympathomimetic bronchodilators for at least 6 hours prior to all study visits. If female, is currently not pregnant, breast feeding, or attempting to become pregnant, has a negative serum pregnancy test, and is of Non-childbearing potential, defined as: Before menarche or > or =1 year post-menopausal or Surgically sterile (tubal ligation, bilateral oophorectomy, or hysterectomy) or Congenital sterility or Diagnosed as infertile and not undergoing treatment to reverse infertility or is of Child-bearing potential, willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study: Systemic contraception used for > or = 1 month prior to screening, including birth control pills, transdermal patch (Ortho Evra®), vaginal ring (NuvaRing®), levonorgesterel (Norplant®), or injectable progesterone (Depo-Provera®) or Double barrier methods (condoms, cervical cap, diaphragm, and vaginal contraceptive film with spermicide) or Intrauterine device (IUD) or is of Child-bearing potential and not sexually active, willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study, in the event the subject becomes sexually active. Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements (visits, record-keeping, etc). Exclusion Criteria: History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures. Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks prior to the Screening Visit. In addition, the subject must be excluded if such infection occurs between the Screening Visit and the Randomization Visit. Any asthma exacerbation requiring oral corticosteroids within 3 months of the Screening Visit. A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit. Note: An exacerbation of asthma is defined as any worsening of asthma requiring any treatment other than rescue albuterol/salbutamol HFA MDI and/or the subject's regular non-corticosteroid maintenance treatment. This includes requiring the use of systemic corticosteroids and/or emergency room visit or hospitalization, a change in the subject's regular non-corticosteroid maintenance treatment, or the addition of other asthma medications. Presence of glaucoma, cataracts, ocular herpes simplex, or malignancy other than basal cell carcinoma. Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (e.g., congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (e.g., uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), gastrointestinal (e.g., poorly-controlled peptic ulcer, GERD), or pulmonary (e.g., chronic bronchitis, emphysema, bronchiectasis with the need for treatment, cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition exacerbated during the study. Have any of the following conditions that, in the judgment of the investigator, might cause participation in this study to be detrimental to the subject, including, but not limited to: Current malignancy excluding basal cell carcinoma; History of malignancy is acceptable only if the subject has been in remission for one year prior to the Screening Visit. (Remission is defined as no current evidence of malignancy and no treatment for the malignancy in the 12 months prior to the Screening Visit) Current or untreated tuberculosis; History of tuberculosis is acceptable only if a subject has received an approved prophylactic treatment regimen or an approved active treatment regimen and has had no evidence of active disease for a minimum of 2 years • Uncontrolled hypertension (systolic BP ≥160 or diastolic BP >100) Stroke within 3 months prior to the Screening Visit Immunologic compromise History of a positive test for HIV, hepatitis B or hepatitis C infection. Clinical visual evidence of oral candidiasis at the Screening Visit. History of any adverse reaction, including immediate or delayed hypersensitivity to any β2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the dry powder inhalers (Spiromax or Diskus) used in the study (i.e., lactose). History of severe allergy to milk protein. Use of systemic, oral or depot corticosteroids within 12 weeks prior to the Screening Visit Use of topical corticosteroids (≤1% hydrocortisone cream) for dermatological disease is permitted Use of intranasal corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit and throughout the study is permitted Use of immunosuppressive medications within 4 weeks prior to the Screening Visit and during the study. Immunotherapy at a stable dose for at least 90 days prior to the Screening Visit and throughout the study for the treatment of allergies is permitted. Use of potent Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole, itraconazole) within 4 weeks prior to the Screening Visit. History of alcohol or drug abuse within two years preceding the Screening Visit. Current smoker or a smoking history of 10 pack years or more (a pack year is defined as smoking 1 pack of cigarettes/day for 1 year). A subject may not have used tobacco products within the past one year (e.g., cigarettes, cigars, chewing tobacco, or pipe tobacco). Study participation by clinical investigator site employees and/or their immediate relatives. Study participation by more than one subject from the same household at the same time. However, after the study completion or discontinuation by one subject another subject from the same household may be screened. Participation in any investigational drug study within the 30 days (starting at the final follow-up visit) preceding the Screening Visit or planned participation in another investigational drug study at any time during this study. Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the subject's last study related visit (for eligible subjects only - if applicable). Eligible female subjects unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded.
Facility Information:
Facility Name
Teva Investigational Site 10165
City
Homewood
State/Province
Alabama
Country
United States
Facility Name
Teva Investigational Site 11142
City
Goodyear
State/Province
Arizona
Country
United States
Facility Name
Teva Investigational Site 10104
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Teva Investigational Site 11149
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Teva Investigational Site 10173
City
Bakersfield
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10163
City
Costa Mesa
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10156
City
Encinitas
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 11101
City
Fountain Valley
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 11111
City
Fresno
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10151
City
Granada Hills
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10157
City
Huntington Beach
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10176
City
Huntington Beach
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10147
City
Long Beach
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 11110
City
Napa
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10136
City
Newport Beach
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 11122
City
North Hollywood
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10140
City
Orange
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10197
City
Palmdale
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10185
City
Redwood City
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10143
City
Riverside
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 11137
City
Roseville
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10130
City
San Diego
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10182
City
San Diego
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10179
City
San Jose
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10106
City
Stockton
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10129
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Teva Investigational Site 10145
City
Centennial
State/Province
Colorado
Country
United States
Facility Name
Teva Investigational Site 10172
City
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
Teva Investigational Site 10133
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Teva Investigational Site 10154
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Teva Investigational Site 11146
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Teva Investigational Site 10128
City
Wheat Ridge
State/Province
Colorado
Country
United States
Facility Name
Teva Investigational Site 10196
City
Waterbury
State/Province
Connecticut
Country
United States
Facility Name
Teva Investigational Site 10191
City
Boynton Beach
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 11127
City
Brandon
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 11118
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 11141
City
Hialeah
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 11140
City
Kissimmee
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10137
City
Miami
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10153
City
Miami
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 11120
City
Miami
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 11128
City
Miami
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 11132
City
Miami
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 11145
City
Miami
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10171
City
Ocala
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10178
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 11103
City
South Miami
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10161
City
Tallahassee
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 10139
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Teva Investigational Site 11114
City
Albany
State/Province
Georgia
Country
United States
Facility Name
Teva Investigational Site 10111
City
Columbus
State/Province
Georgia
Country
United States
Facility Name
Teva Investigational Site 11124
City
Columbus
State/Province
Georgia
Country
United States
Facility Name
Teva Investigational Site 10180
City
Gainesville
State/Province
Georgia
Country
United States
Facility Name
Teva Investigational Site 10168
City
Lawrenceville
State/Province
Georgia
Country
United States
Facility Name
Teva Investigational Site 11109
City
Idaho Falls
State/Province
Idaho
Country
United States
Facility Name
Teva Investigational Site 10116
City
Meridian
State/Province
Idaho
Country
United States
Facility Name
Teva Investigational Site 10127
City
South Bend
State/Province
Indiana
Country
United States
Facility Name
Teva Investigational Site 10184
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
Teva Investigational Site 10113
City
Metairie
State/Province
Louisiana
Country
United States
Facility Name
Teva Investigational Site 10164
City
Bangor
State/Province
Maine
Country
United States
Facility Name
Teva Investigational Site 10158
City
Bethesda
State/Province
Maryland
Country
United States
Facility Name
Teva Investigational Site 10110
City
Largo
State/Province
Maryland
Country
United States
Facility Name
Teva Investigational Site 10177
City
Wheaton
State/Province
Maryland
Country
United States
Facility Name
Teva Investigational Site 10138
City
North Dartmouth
State/Province
Massachusetts
Country
United States
Facility Name
Teva Investigational Site 10146
City
North Dartmouth
State/Province
Massachusetts
Country
United States
Facility Name
Teva Investigational Site 10131
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Teva Investigational Site 10175
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Teva Investigational Site 10189
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Teva Investigational Site 11147
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Teva Investigational Site 10118
City
Bellevue
State/Province
Nebraska
Country
United States
Facility Name
Teva Investigational Site 10150
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Teva Investigational Site 11144
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Teva Investigational Site 11136
City
Henderson
State/Province
Nevada
Country
United States
Facility Name
Teva Investigational Site 10114
City
Bricktown
State/Province
New Jersey
Country
United States
Facility Name
Teva Investigational Site 10193
City
Cherry Hill
State/Province
New Jersey
Country
United States
Facility Name
Teva Investigational Site 10101
City
Hillsborough
State/Province
New Jersey
Country
United States
Facility Name
Teva Investigational Site 10155
City
Skillman
State/Province
New Jersey
Country
United States
Facility Name
Teva Investigational Site 10188
City
West Orange
State/Province
New Jersey
Country
United States
Facility Name
Teva Investigational Site 11113
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Teva Investigational Site 10187
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 10120
City
New York
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 10190
City
Newburgh
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 10167
City
North Syracuse
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 10112
City
Rochester
State/Province
New York
Country
United States
Facility Name
Teva Investigational Site 10105
City
High Point
State/Province
North Carolina
Country
United States
Facility Name
Teva Investigational Site 10122
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Teva Investigational Site 10194
City
Canton
State/Province
Ohio
Country
United States
Facility Name
Teva Investigational Site 10107
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Teva Investigational Site 10123
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Teva Investigational Site 10144
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Teva Investigational Site 11135
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Teva Investigational Site 11115
City
Middleburg Heights
State/Province
Ohio
Country
United States
Facility Name
Teva Investigational Site 10160
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Teva Investigational Site 10174
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Teva Investigational Site 10198
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Teva Investigational Site 11108
City
Ashland
State/Province
Oregon
Country
United States
Facility Name
Teva Investigational Site 10132
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
Teva Investigational Site 10135
City
Medford
State/Province
Oregon
Country
United States
Facility Name
Teva Investigational Site 10142
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Teva Investigational Site 11104
City
Normal
State/Province
Pennsylvania
Country
United States
Facility Name
Teva Investigational Site 10183
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Teva Investigational Site 10166
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Teva Investigational Site 10121
City
Upland
State/Province
Pennsylvania
Country
United States
Facility Name
Teva Investigational Site 11119
City
East Providence
State/Province
Rhode Island
Country
United States
Facility Name
Teva Investigational Site 10181
City
Lincoln
State/Province
Rhode Island
Country
United States
Facility Name
Teva Investigational Site 10162
City
Providence
State/Province
Rhode Island
Country
United States
Facility Name
Teva Investigational Site 10126
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Teva Investigational Site 10149
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Teva Investigational Site 10199
City
Orangeburg
State/Province
South Carolina
Country
United States
Facility Name
Teva Investigational Site 11131
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
Teva Investigational Site 10119
City
Boerne
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10141
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10192
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10148
City
El Paso
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10115
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 11133
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 11134
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 10103
City
Waco
State/Province
Texas
Country
United States
Facility Name
Teva Investigational Site 11143
City
Layton
State/Province
Utah
Country
United States
Facility Name
Teva Investigational Site 10195
City
Provo
State/Province
Utah
Country
United States
Facility Name
Teva Investigational Site 10134
City
South Burlington
State/Province
Vermont
Country
United States
Facility Name
Teva Investigational Site 10159
City
Burke
State/Province
Virginia
Country
United States
Facility Name
Teva Investigational Site 10102
City
Fairfax
State/Province
Virginia
Country
United States
Facility Name
Teva Investigational Site 11105
City
Manassas
State/Province
Virginia
Country
United States
Facility Name
Teva Investigational Site 10108
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Teva Investigational Site 10124
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Teva Investigational Site 11117
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
Teva Investigational Site 11125
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
Teva Investigational Site 10170
City
Greenfield
State/Province
Wisconsin
Country
United States
Facility Name
Teva Investigational Site 59107
City
Burgas
Country
Bulgaria
Facility Name
Teva Investigational Site 59103
City
Lovech
Country
Bulgaria
Facility Name
Teva Investigational Site 59106
City
Pleven
Country
Bulgaria
Facility Name
Teva Investigational Site 59104
City
Ruse
Country
Bulgaria
Facility Name
Teva Investigational Site 59101
City
Sofia
Country
Bulgaria
Facility Name
Teva Investigational Site 59102
City
Sofia
Country
Bulgaria
Facility Name
Teva Investigational Site 59105
City
Sofia
Country
Bulgaria
Facility Name
Teva Investigational Site 85105
City
Split
Country
Croatia
Facility Name
Teva Investigational Site 85102
City
Zagreb
Country
Croatia
Facility Name
Teva Investigational Site 85103
City
Zagreb
Country
Croatia
Facility Name
Teva Investigational Site 85104
City
Zagreb
Country
Croatia
Facility Name
Teva Investigational Site 36107
City
Balassagyarmat
Country
Hungary
Facility Name
Teva Investigational Site 36104
City
Budapest
Country
Hungary
Facility Name
Teva Investigational Site 36105
City
Budapest
Country
Hungary
Facility Name
Teva Investigational Site 36113
City
Csoma
Country
Hungary
Facility Name
Teva Investigational Site 36103
City
Miskolc
Country
Hungary
Facility Name
Teva Investigational Site 36108
City
Mosdos
Country
Hungary
Facility Name
Teva Investigational Site 36102
City
Nyiregyhaza
Country
Hungary
Facility Name
Teva Investigational Site 36106
City
Szeged
Country
Hungary
Facility Name
Teva Investigational Site 36109
City
Szeged
Country
Hungary
Facility Name
Teva Investigational Site 36101
City
Szombathely
Country
Hungary
Facility Name
Teva Investigational Site 36111
City
Tatabanya
Country
Hungary
Facility Name
Teva Investigational Site 72111
City
Ashkelon
Country
Israel
Facility Name
Teva Investigational Site 72101
City
Haifa
Country
Israel
Facility Name
Teva Investigational Site 72102
City
Jerusalem
Country
Israel
Facility Name
Teva Investigational Site 72104
City
Jerusalem
Country
Israel
Facility Name
Teva Investigational Site 72109
City
Kfar Saba
Country
Israel
Facility Name
Teva Investigational Site 72106
City
Petach Tikva
Country
Israel
Facility Name
Teva Investigational Site 72107
City
Ramat-Gan
Country
Israel
Facility Name
Teva Investigational Site 72103
City
Rehovot
Country
Israel
Facility Name
Teva Investigational Site 72110
City
Tel Aviv
Country
Israel
Facility Name
Teva Investigational Site 72108
City
Tel-Aviv
Country
Israel
Facility Name
Teva Investigational Site 48107
City
Bialystok
Country
Poland
Facility Name
Teva Investigational Site 48105
City
Bydgoszcz
Country
Poland
Facility Name
Teva Investigational Site 48106
City
Grodzisk Mazowiecki
Country
Poland
Facility Name
Teva Investigational Site 48101
City
Lodz
Country
Poland
Facility Name
Teva Investigational Site 48108
City
Poznan
Country
Poland
Facility Name
Teva Investigational Site 48103
City
Tarnow
Country
Poland
Facility Name
Teva Investigational Site 48104
City
Wroclaw
Country
Poland
Facility Name
Teva Investigational Site 81101
City
Belgrade
Country
Serbia
Facility Name
Teva Investigational Site 81102
City
Belgrade
Country
Serbia
Facility Name
Teva Investigational Site 34101
City
Badalona
Country
Spain
Facility Name
Teva Investigational Site 34102
City
Barcelona
Country
Spain
Facility Name
Teva Investigational Site 34103
City
Salt
Country
Spain
Facility Name
Teva Investigational Site 80101
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Teva Investigational Site 80113
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Teva Investigational Site 80111
City
Donetsk
Country
Ukraine
Facility Name
Teva Investigational Site 80103
City
Kharkiv
Country
Ukraine
Facility Name
Teva Investigational Site 80117
City
Kharkiv
Country
Ukraine
Facility Name
Teva Investigational Site 80104
City
Kyiv
Country
Ukraine
Facility Name
Teva Investigational Site 80105
City
Kyiv
Country
Ukraine
Facility Name
Teva Investigational Site 80106
City
Kyiv
Country
Ukraine
Facility Name
Teva Investigational Site 80107
City
Kyiv
Country
Ukraine
Facility Name
Teva Investigational Site 80108
City
Kyiv
Country
Ukraine
Facility Name
Teva Investigational Site 80109
City
Kyiv
Country
Ukraine
Facility Name
Teva Investigational Site 80114
City
Odesa
Country
Ukraine
Facility Name
Teva Investigational Site 80118
City
Ternopil
Country
Ukraine
Facility Name
Teva Investigational Site 80112
City
Vinnytsya
Country
Ukraine
Facility Name
Teva Investigational Site 80115
City
Yalta
Country
Ukraine
Facility Name
Teva Investigational Site 80110
City
Zaporizhzhia
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler in Adolescents and Adults Who Have Asthma That is Not Controlled by Asthma Medications Not Containing Steroids

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