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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 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.

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

Page last updated: August 23, 2015

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