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)
Information source: Teva Pharmaceutical Industries
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Albuterol dry powder inhaler (Drug); Albuterol HFA MDI (hydrofluoroalkane metered dose inhaler) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Teva Branded Pharmaceutical Products, R&D Inc. Official(s) and/or principal investigator(s): Clinical Program Leader, Study Director, Affiliation: Teva Branded Pharmaceutical Products, R&D Inc.
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Baseline-adjusted forced expiratory volume in one second (FEV1) 30 minutes after each of the five cumulative doses
Secondary outcome: 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 doseECGs (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. 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.
Detailed description:
The study objective is to compare the efficacy and safety of albuterol in a dry powder
inhaler (DPI) and albuterol in an HFA metered dose inhaler (MDI) after a cumulative dose of
1440mcg administered as 1+1+2+4+8 inhalations (90mcg per inhalation). Another study
objective is to compare the pharmacokinetics (metabolism) of albuterol with the two
inhalers. The pharmacokinetics of albuterol will be examined in half (24) of the study
subjects. To participate in the study, patients must provide written informed consent,
washout any prohibited medications and pass all the screen criteria. Once this is done,
there will be two treatment visits. At each visit the subject will inhale with both types of
inhalers. At each visit, one inhaler will have active drug (albuterol) and one inhaler will
have placebo (dummy). The inhaler with the active drug will be switched at the two visits
in a random manner. At each visit the subject will inhale with each inhaler a total of 16
times by a specific schedule. The subject will inhale from each inhaler once (1), wait 30
minutes, inhale from each inhaler once (1), wait 30 minutes, inhale from each inhaler twice
(2), wait 30 minutes, inhale from each inhaler four times (4), wait 30 minutes, and then
inhale from each inhaler eight times (8). The total time to complete the inhalations should
be about 2 hours. Following that, there will be a series of assessments taken at regular
times with vital signs measured up to 6 hours, ECG (electrocardiogram) assessed up to 4
hours, blood taken to measure potassium and glucose up to 4 hours, lung function evaluated
with spirometry up to 6 hours, and for those subjects participating in the pharmacokinetic
evaluation blood will be drawn up to 12 hours. The two study treatment visits will be 3 to
14 days apart. Following these visits, there will be a study concluding visit 1 to 5 days
later.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
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
Additional Information
Starting date: January 2010
Last updated: May 11, 2012
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