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A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 and Older With Persistent Asthma

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 Spiromax® (Drug); ProAir® HFA (Drug); Placebo Inhaler (Other)

Phase: Phase 2

Status: Completed

Sponsored by: Teva Branded Pharmaceutical Products, R&D Inc.

Official(s) and/or principal investigator(s):
Teva Study Leader, Study Director, Affiliation: Teva Branded Pharmaceutical Products, R&D Inc.

Summary

This study is examining how well a dry powder inhaler (DPI) of albuterol medication works to help adult and adolescent subjects 12 years of age and older with persistent asthma to improve lung function.

Clinical Details

Official title: A Double-blind, Randomized, Placebo-controlled, 5-way Crossover, Multicenter, Single-dose, Dose-ranging Study to Compare the Efficacy and Safety of Albuterol Spiromax« and ProAir« HFA in Adult and Adolescent Subjects Ages 12 and Older With Persistent Asthma

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6)

Secondary outcome:

Baseline-adjusted Percent-Predicted Forced Expiratory Volume in 1 Second (PPFEV1) Area Under the Curve (AUC 0-6)

Participants With Treatment-Emergent Adverse Events

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Must provide written informed consent,

- Be between 12 years of age and older,

- 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 180 mcg albuterol

- Stable low dose of Inhaled Corticosteroids

- Non-smoker, 12 months smoking-free and <=10-pack years history

- Otherwise healthy

- Other criteria apply

Exclusion Criteria:

- Pregnant

- Allergic to albuterol or severe milk protein allergy

- Must not be on another trial for 30days.

- Other criteria apply

Locations and Contacts

Teva Clinical Study Site, Huntington Beach, California 92647, United States

Teva Clinical Study Site, Rolling Hills Est., California 90274, United States

Teva Clinical Study Site, San Diego, California 92123, United States

Teva Clinical Study Site, Colorado Springs, Colorado 080907, United States

Teva Clinical Study Site, Margate, Florida 33036, United States

Teva Clinical Study Site, Miami, Florida 33173, United States

Teva Clinical Study Site, St. Louis, Missouri 63141, United States

Teva Clinical Study Site, Skillman, New Jersey 08558, United States

Teva Clinical Study Site, Raleigh, North Carolina 27607, United States

Teva Clinical Study Site, Cincinnati, Ohio 45231, United States

Teva Clinical Study Site, Dayton, Ohio 45406, United States

Teva Clinical Study Site, Medford, Oregon 97504, United States

Teva Clinical Study Site, Portland, Oregon 97213, United States

Additional Information

Starting date: February 2010
Last updated: May 19, 2015

Page last updated: August 23, 2015

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