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A Twelve Month Long Term Safety Study to Evaluate the Safety of Albuterol in a Dry Powder Inhaler With Both Repeated and as Needed Dosing

Primary Purpose

Asthma

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placebo Spiromax
Albuterol Spiromax
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 asthma, dry powder inhaler, short-acting beta2-agonist, SABA, bronchoconstriction, bronchodilation, bronchodilator, metered dose inhaler

Eligibility Criteria

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

Inclusion Criteria:

  • Documented history of persistent asthma with rescue use of albuterol on average of at least once/ week over the 4-weeks prior to screening.
  • Female subjects who are of childbearing potential (as judged by the investigator) must be currently using and willing to continue to use a medically reliable method of contraception for the entire study duration
  • General good health
  • Capable of understanding the requirements, risks, and benefits of study participation
  • Non-smoker for at least one year prior to the screening visit and a maximum pack-year smoking history of 10 years
  • Other criteria apply

Exclusion Criteria:

  • 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
  • Participation in any investigational drug trial within 30 days preceding the screening visit
  • A known hypersensitivity to albuterol or any of the excipients in the formulations.
  • History of severe milk protein allergy
  • History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, otitis media, influenza, etc) which is not resolved within 1 week prior to the Screening Visit.
  • Use of any protocol prohibited concomitant medications for asthma or any protocol prohibited concomitant non-asthma medications
  • Inability to tolerate or unwillingness to comply with the protocol requirements.
  • History of life-threatening asthma
  • Any asthma exacerbation within 3 months of the Screening Visit requiring oral or systemic corticosteroids
  • History of life-threatening asthma
  • Other criteria apply

Sites / Locations

  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site
  • Teva Clinical Study Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Albuterol Spiromax

Placebo Spiromax

Arm Description

Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).

Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).

Outcomes

Primary Outcome Measures

Participants With Treatment-Emergent Adverse Events
Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol 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. Relation 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.
Changes From Screening in the Results of the Physical Examination That Are Clinically Significant in the Opinion of the Investigator
A complete physical examination was planned at study screening, week 12 and week 52 or early termination/discontinuation of the participant. At weeks 12 and 52,the qualified healthcare professional was to evaluate whether each physical finding is a new finding, worsening, improvement or resolution of an existing condition compared with the baseline physical exam. Where possible, the same qualified healthcare professional that performed the physical examination at study screening should perform all the scheduled physical examinations.
Changes From Screening in the Results of the Laboratory Evaluations That Are Clinically Significant in the Opinion of the Investigator
Blood samples were to collected for laboratory evaluations at the screening visit and at weeks 12 and 52 or early termination/discontinuation of the participant. The blood samples were to be drawn after an overnight fast of at least 6 hours and analyzed by a central laboratory.
Changes From Screening in the Results of the Electrocardiograms (ECGs) That Are Clinically Significant in the Opinion of the Investigator
A standard 12-lead ECG was to be performed at screening and at week 12 and week 52 (TV15) or early termination/discontinuation of the participant. The ECG recording methods were to be centralized and standardized across all study subjects.
Changes From Screening in the Vital Signs That Are Clinically Significant in the Opinion of the Investigator
Vital sign measurements (heart rate and blood pressure) were to be evaluated as part of the safety profile assessment. The participant was to be seated at least 2 minutes before vital signs were performed. Either an electronic or manual sphygmomanometer could be used.

Secondary Outcome Measures

Full Information

First Posted
October 7, 2010
Last Updated
May 1, 2015
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01218009
Brief Title
A Twelve Month Long Term Safety Study to Evaluate the Safety of Albuterol in a Dry Powder Inhaler With Both Repeated and as Needed Dosing
Official Title
A Multi-Center 52-Week Study to Assess the Safety of an Albuterol Dry-powder Inhaler in Subjects With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
Change to study required.
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a one-year study to look at the safety of a dry powder inhaler with albuterol. After a one-week run in, for the first 3 months subjects will use an inhaler with either albuterol or a dummy drug at regular times four times a day. Then for the last nine months of the study, all subjects will be given the albuterol dry powder inhaler and will use it only when needed to help with breathing problems. Subjects will need to keep a daily diary (both paper and electronic) throughout the study recording any inhaler use and health problems. There will be visits to the study doctor about once a month for a year. This study is intended to show that the albuterol dry powder inhaler works well and is safe for use over a long period of time.
Detailed Description
The Sponsor terminated this study due to the need for a modification to the Spiromax device utilized in this study; the problem identified has no impact on patient safety. Exposure ranged from 3 to 49 days with the majority of subjects receiving ≤30 days of double-blind treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, dry powder inhaler, short-acting beta2-agonist, SABA, bronchoconstriction, bronchodilation, bronchodilator, metered dose inhaler

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
331 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Albuterol Spiromax
Arm Type
Experimental
Arm Description
Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Arm Title
Placebo Spiromax
Arm Type
Placebo Comparator
Arm Description
Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
Intervention Type
Drug
Intervention Name(s)
Placebo Spiromax
Intervention Description
Placebo as a dry-powder inhaled orally using the Spiromax inhaler. During the 12-week double-blind period, participants take two (2) inhalations four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
Intervention Type
Drug
Intervention Name(s)
Albuterol Spiromax
Other Intervention Name(s)
ProAir® RespiClick, Albuterol multi-dose dry powder inhaler (MDPI)
Intervention Description
Albuterol as a dry-powder inhaled orally using the Spiromax inhaler. Each inhalation delivers 90 micrograms (mcg). During the 12-week double-blind period, participants take two (2) inhalations four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total dose of 720 micrograms per day for those paricipants randomized to the Albuterol treatment arm. The double-blind period is followed by a 40-week open-label period in which all study participants will take Albuterol Spiromax 90 micrograms (mcg)/inhalation as needed (PRN).
Primary Outcome Measure Information:
Title
Participants With Treatment-Emergent Adverse Events
Description
Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol 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. Relation 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 to Day 49 (study termination)
Title
Changes From Screening in the Results of the Physical Examination That Are Clinically Significant in the Opinion of the Investigator
Description
A complete physical examination was planned at study screening, week 12 and week 52 or early termination/discontinuation of the participant. At weeks 12 and 52,the qualified healthcare professional was to evaluate whether each physical finding is a new finding, worsening, improvement or resolution of an existing condition compared with the baseline physical exam. Where possible, the same qualified healthcare professional that performed the physical examination at study screening should perform all the scheduled physical examinations.
Time Frame
Days -15 to -8 (Screening), Week 12, Week 52
Title
Changes From Screening in the Results of the Laboratory Evaluations That Are Clinically Significant in the Opinion of the Investigator
Description
Blood samples were to collected for laboratory evaluations at the screening visit and at weeks 12 and 52 or early termination/discontinuation of the participant. The blood samples were to be drawn after an overnight fast of at least 6 hours and analyzed by a central laboratory.
Time Frame
Days -15 to -8 (Screening), Week 12, Week 52
Title
Changes From Screening in the Results of the Electrocardiograms (ECGs) That Are Clinically Significant in the Opinion of the Investigator
Description
A standard 12-lead ECG was to be performed at screening and at week 12 and week 52 (TV15) or early termination/discontinuation of the participant. The ECG recording methods were to be centralized and standardized across all study subjects.
Time Frame
Days -15 to -8 (Screening), Week 12, Week 52
Title
Changes From Screening in the Vital Signs That Are Clinically Significant in the Opinion of the Investigator
Description
Vital sign measurements (heart rate and blood pressure) were to be evaluated as part of the safety profile assessment. The participant was to be seated at least 2 minutes before vital signs were performed. Either an electronic or manual sphygmomanometer could be used.
Time Frame
Days -15 to -8 (Screening), Week 12, Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented history of persistent asthma with rescue use of albuterol on average of at least once/ week over the 4-weeks prior to screening. Female subjects who are of childbearing potential (as judged by the investigator) must be currently using and willing to continue to use a medically reliable method of contraception for the entire study duration General good health Capable of understanding the requirements, risks, and benefits of study participation Non-smoker for at least one year prior to the screening visit and a maximum pack-year smoking history of 10 years Other criteria apply Exclusion Criteria: 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 Participation in any investigational drug trial within 30 days preceding the screening visit A known hypersensitivity to albuterol or any of the excipients in the formulations. History of severe milk protein allergy History of a respiratory infection or disorder (including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, otitis media, influenza, etc) which is not resolved within 1 week prior to the Screening Visit. Use of any protocol prohibited concomitant medications for asthma or any protocol prohibited concomitant non-asthma medications Inability to tolerate or unwillingness to comply with the protocol requirements. History of life-threatening asthma Any asthma exacerbation within 3 months of the Screening Visit requiring oral or systemic corticosteroids History of life-threatening asthma Other criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Project Leader
Organizational Affiliation
Teva Respiratory R&D
Official's Role
Study Director
Facility Information:
Facility Name
Teva Clinical Study Site
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Teva Clinical Study Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Teva Clinical Study Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Teva Clinical Study Site
City
Centennial
State/Province
Colorado
Country
United States
Facility Name
Teva Clinical Study Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Teva Clinical Study Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Teva Clinical Study Site
City
Gainesville
State/Province
Georgia
Country
United States
Facility Name
Teva Clinical Study Site
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Teva Clinical Study Site
City
Wheaton
State/Province
Maryland
Country
United States
Facility Name
Teva Clinical Study Site
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Teva Clinical Study Site
City
Plymouth
State/Province
Minnesota
Country
United States
Facility Name
Teva Clinical Study Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Teva Clinical Study Site
City
Bellevue
State/Province
Nebraska
Country
United States
Facility Name
Teva Clinical Study Site
City
Boys Town
State/Province
Nebraska
Country
United States
Facility Name
Teva Clinical Study Site
City
Skillman
State/Province
New Jersey
Country
United States
Facility Name
Teva Clinical Study Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
Teva Clinical Study Site
City
Rockville Centre
State/Province
New York
Country
United States
Facility Name
Teva Clinical Study Site
City
High Point
State/Province
North Carolina
Country
United States
Facility Name
Teva Clinical Study Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Teva Clinical Study Site
City
Canton
State/Province
Ohio
Country
United States
Facility Name
Teva Clinical Study Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Teva Clinical Study Site
City
Sylvania
State/Province
Ohio
Country
United States
Facility Name
Teva Clinical Study Site
City
Eugene
State/Province
Oregon
Country
United States
Facility Name
Teva Clinical Study Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Teva Clinical Study Site
City
El Paso
State/Province
Texas
Country
United States
Facility Name
Teva Clinical Study Site
City
New Braunfels
State/Province
Texas
Country
United States
Facility Name
Teva Clinical Study Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Teva Clinical Study Site
City
Burke
State/Province
Virginia
Country
United States
Facility Name
Teva Clinical Study Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Teva Clinical Study Site
City
Greenfield
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Twelve Month Long Term Safety Study to Evaluate the Safety of Albuterol in a Dry Powder Inhaler With Both Repeated and as Needed Dosing

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