A Cumulative Dose Study to Evaluate the Safety and Efficacy of Albuterol in a Dry Powder Inhaler and an HFA MDI (Hydrofluoroalkane Metered Dose Inhaler)
Cumulative Dose Comparison of the Efficacy and Safety of Albuterol in a Dry Powder Inhaler and an HFA MDI (Hydrofluoroalkane Metered Dose Inhaler) in Adult Patients With Asthma
1 other identifier
interventional
47
1 country
9
Brief Summary
The study will measure the improvement in lung function in subjects with asthma after inhaling from two inhalers, Albuterol in a dry powder inhaler and albuterol in an HFA (hydrofluoroalkane), metered dose inhaler.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 asthma
Started Jan 2010
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 22, 2010
CompletedFirst Posted
Study publicly available on registry
January 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFebruary 2, 2022
January 1, 2022
5 months
January 22, 2010
January 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Baseline-adjusted forced expiratory volume in one second (FEV1) 30 minutes after each of the five cumulative doses
At the two study treatment visits, FEV1 (forced expiratory volume in 1 second) will be measured prior to drug administration and 5 times, once at 30 minutes after each of the 5 doses.
Secondary Outcomes (3)
Baseline-adjusted FEV1 (forced expiratory volume in 1 second) AUC0-6 (area under the serum concentration time curve from time 0 to 6 hours) following the administration of the final cumulative dose
At the two study treatment visits, FEV1 (forced expiratory volume in 1 second) will be measured prior to drug administration and 7 time points ( 30 minutes and 1,2,3,4,5 and 6 hours) after the 5th and final dose.
ECGs (electrocardiogram) will assess the maximum and mean change from baseline of the corrected QT interval (QT interval measures the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle) following study drug.
Serial ECGs (electrocardiogram) will be taken at baseline (5 minutes pre-dose), 15 minutes after each dose, and also at 30 minutes, 60 minutes, 2, 3, and 4 hours following the last cumulative dose in order to calculate the corrected QT interval.
Changes in blood pressure will be evaluated by the maximum change (systolic) and minimum change (diastolic) from baseline blood pressure, and the weighted mean change from baseline in systolic and diastolic blood pressure.
Serial measurements of systolic and diastolic blood pressure will be taken at baseline (15 minutes pre-dose), 15 minutes after each dose, and also at 30 minutes, 60 minutes, 2, 3, 4, 5, and 6 hours following the last cumulative dose.
Study Arms (2)
Albuterol dry powder inhaler
EXPERIMENTALThe participants will receive albuterol delivered with the a DPI (dry powder inhaler) and placebo with an HFA MDI inhaler (hydrofluoroalkane metered dose inhaler).
Albuterol HFA MDI
ACTIVE COMPARATORThe participants will receive albuterol delivered with an HFA MDI inhaler (hydrofluoroalkane metered dose inhaler) and placebo with albuterol in a DPI (dry powder inhaler).
Interventions
Albuterol DPI (dry powder inhaler) delivers 90mcg of albuterol in the excipient lactose with each inhalation. Albuterol will be given on two treatment days (3 to 14 days apart). On each treatment day albuterol will be given as a cumulative dose of 1440mcg as a series of inhalations using both Albuterol in a DPI (dry Powder inhaler) and albuterol in an HFA MDI (hydrofluoroalkane metered dose inhaler), ProAir. One inhaler will contain active drug and one inhaler will contain placebo.
Albuterol HFA MDI (hydrofluoroalkane metered dose inhaler) delivers 90mcg of albuterol with each inhalation. Albuterol will be given on two treatment days (3to 14 days apart). On each treatment day albuterol will be given as a cumulative dose of 1440mcg as a series of inhalations using both Albuterol DPI (dry powder inhaler) and the comparator inhaler, albuterol HFA MDI (hydrofluoroalkane metered dose inhaler).One inhaler will contain active drug and one inhaler will contain placebo.
Eligibility Criteria
You may qualify if:
- Must provide written informed consent,
- Must be between 18-45 years of age,
- Male or Female, females of non-child bearing potential or using reliable contraception
- Asthma for at least 6 months, FEV1 (forced expiratory volume in 1 second) between 50-80% of predicted value, and reversibility greater than or equal to 15% following 180mcg albuterol
- Stable low dose of Inhaled Corticosteroids
- Non-smoker
- Otherwise healthy
- Other criteria apply
You may not qualify if:
- Pregnant
- Allergic to albuterol or severe milk protein allergy
- ONLY for subject participating in PK assessments, must not have donated blood within 30 days.
- Other criteria apply
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Teva Branded Pharmaceutical Products R&D, Inc.lead
- Parexelcollaborator
Study Sites (9)
Teva Clinical Study Site
Los Angeles, California, 90025, United States
Teva Clinical Study Site
Los Angeles, California, 90048, United States
Teva Clinical Study Site
Denver, Colorado, 80230, United States
Teva Clinical Study Site
Lakewood, Colorado, 80401, United States
Teva Clinical Study Site
Normal, Illinois, 61761, United States
Teva Clinical Study Site
North Dartmouth, Massachusetts, 02747, United States
Teva Clinical Study Site
Minneapolis, Minnesota, 55402, United States
Teva Clinical Study Site
Bellevue, Nebraska, 68123, United States
Teva Clinical Study Site
Lake Oswego, Oregon, 97035, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Program Leader
Teva Branded
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2010
First Posted
January 26, 2010
Study Start
January 1, 2010
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
February 2, 2022
Record last verified: 2022-01