Back to resultsEfficacy and Safety of Mometasone Furoate for Persistent Asthma Previously Treated With Low-Dose Inhaled Glucocorticosteroids (ICS) (Study P06115)
Primary Purpose
Asthma
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
SCH 32088 mometasone furoate (MF) metered-dose inhaler
Placebo metered-dose inhaler BID
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- An adult or adolescent subject with a diagnosis of persistent asthma of >=6 months duration may be selected for this study.
- Both subject (and/or parent/guardian, if appropriate) and investigator must agree that changing therapy is acceptable and poses no inherent risk.
- Subject must have been using a low daily maintenance dose of inhaled corticosteroids (ICS), with or without added long-acting β2-agonist (LABA), for >=12 weeks prior to Screening, and must have been on a stable regimen (daily dose unchanged) for at least the last 2 weeks of that period.
- At Screening, the subject must have a prebronchodilator FEV1 between 60% and 90% of the predicted value when restricted medications have been withheld.
- To be randomized, the subjects must be symptomatic with FEV1 at Baseline must be between 50% and 85% of predicted.
Exclusion Criteria:
- A subject must not have been admitted to the hospital for management of airway obstruction within the last 3 months prior to Screening, and must not have experienced an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication, as judged by the clinical investigator at any time from Screening to Baseline/Randomization.
- In addition, a subject must not have demonstrated a decrease in absolute FEV1 of >20% at any time from Screening to Baseline, or a decrease in AM peak expiratory flow (PEF) below the PEF stability limit on any 2 consecutive days prior to Baseline/Randomization.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Mometasone furoate (MF) metered-dose inhaler 100 mcg BID
Placebo metered-dose inhaler BID
Arm Description
2 inhalations from a MF 50 mcg inhaler each morning and evening, approximately 12 hours apart, for 12 weeks
2 inhalations from a matching placebo inhaler each morning and evening, approximately 12 hours apart, for 12 weeks.
Outcomes
Primary Outcome Measures
Change from Baseline to Endpoint in the morning (AM trough) forced expiratory volume in 1 second (FEV1)
Secondary Outcome Measures
Time to first severe asthma exacerbation during the 12 week Treatment Period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01026870
Brief Title
Efficacy and Safety of Mometasone Furoate for Persistent Asthma Previously Treated With Low-Dose Inhaled Glucocorticosteroids (ICS) (Study P06115)
Official Title
A 12-Week Placebo-Controlled Efficacy and Safety Study of Mometasone Furoate Monotherapy in Subjects With Persistent Asthma Previously Treated With Low-Dose Inhaled Glucocorticosteroids
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Mometasone furoate (MF) is a synthetic glucocorticosteroid that, when administered to asthma patients with a dry powder inhaler (Asmanex® Twisthaler®) at dosages of 100 to 400 mcg twice daily, has been shown to improve lung function, reduce symptoms of asthma, and reduce frequency and severity of exacerbations by reducing airway inflammation, with a relatively low potential to cause systemic side effects such as hypothalamic-pituitary-adrenal (HPA) axis suppression.
An experimental formulation of MF 100 mcg delivered twice daily via a pressurized metered-dose inhaler (MDI) also has been shown to be effective in improving lung function of asthma patients as measured by forced expiratory volume in 1 second (FEV1). This trial is designed to verify the effectiveness of twice daily MF MDI 100 mcg in treating asthma in adults and adolescents previously treated with low dosages of inhaled corticosteroids (ICS), as measured by improvement in morning FEV1 and time to first asthma exacerbation over 12 weeks of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mometasone furoate (MF) metered-dose inhaler 100 mcg BID
Arm Type
Active Comparator
Arm Description
2 inhalations from a MF 50 mcg inhaler each morning and evening, approximately 12 hours apart, for 12 weeks
Arm Title
Placebo metered-dose inhaler BID
Arm Type
Placebo Comparator
Arm Description
2 inhalations from a matching placebo inhaler each morning and evening, approximately 12 hours apart, for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
SCH 32088 mometasone furoate (MF) metered-dose inhaler
Other Intervention Name(s)
SCH 032088
Intervention Description
2 inhalations from a MF 50 mcg inhaler each morning and evening, approximately 12 hours apart, for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo metered-dose inhaler BID
Intervention Description
2 inhalations from a placebo metered-dose inhaler each morning and evening, approximately 12 hours apart, for 12 weeks.
Primary Outcome Measure Information:
Title
Change from Baseline to Endpoint in the morning (AM trough) forced expiratory volume in 1 second (FEV1)
Time Frame
Endpoint: last non-missing post-Baseline observation carried forward over 12 weeks of treatment
Secondary Outcome Measure Information:
Title
Time to first severe asthma exacerbation during the 12 week Treatment Period
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
An adult or adolescent subject with a diagnosis of persistent asthma of >=6 months duration may be selected for this study.
Both subject (and/or parent/guardian, if appropriate) and investigator must agree that changing therapy is acceptable and poses no inherent risk.
Subject must have been using a low daily maintenance dose of inhaled corticosteroids (ICS), with or without added long-acting β2-agonist (LABA), for >=12 weeks prior to Screening, and must have been on a stable regimen (daily dose unchanged) for at least the last 2 weeks of that period.
At Screening, the subject must have a prebronchodilator FEV1 between 60% and 90% of the predicted value when restricted medications have been withheld.
To be randomized, the subjects must be symptomatic with FEV1 at Baseline must be between 50% and 85% of predicted.
Exclusion Criteria:
A subject must not have been admitted to the hospital for management of airway obstruction within the last 3 months prior to Screening, and must not have experienced an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication, as judged by the clinical investigator at any time from Screening to Baseline/Randomization.
In addition, a subject must not have demonstrated a decrease in absolute FEV1 of >20% at any time from Screening to Baseline, or a decrease in AM peak expiratory flow (PEF) below the PEF stability limit on any 2 consecutive days prior to Baseline/Randomization.
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Mometasone Furoate for Persistent Asthma Previously Treated With Low-Dose Inhaled Glucocorticosteroids (ICS) (Study P06115)
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