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A 12-week Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years 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: Placebo MDPI (Drug); Albuterol MDPI (Drug)

Phase: Phase 3

Status: Completed

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

Official(s) and/or principal investigator(s):
Clinical Project Leader, Study Director, Affiliation: Teva Respiratory R&D

Summary

The study will measure the change in lung function in subjects with asthma after inhaling from either of two inhalers: Albuterol Spiromax« or placebo.

Clinical Details

Official title: A 12-week Comparison of the Efficacy and Safety of Albuterol Spiromax« Versus Placebo in Subjects 12 Years and Older With Persistent Asthma

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period

Secondary outcome:

Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1

Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8

Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85

Participants With Adverse Events

Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group

Participants With Clinically Significant Vital Sign Assessments

Eligibility

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

Criteria:

Inclusion Criteria:

- Written informed consent/assent

- General good health

- Persistent asthma, with an FEV1 50-80% predicted.

- Ability to perform spirometry in an acceptable manner as per protocol guidelines.

- Ability to perform PEFR with a handheld peak flow meter.

- Demonstration of reversible bronchoconstriction as verified by a 15% or greater

increase from baseline FEV1.

- Taking inhaled corticosteroids at a stable dose for at least 4 weeks prior to the

Screening Visit.

- Non-smokers.

- Capable of understanding the requirements, risks, and benefits of study

participation.

- Other inclusion criteria apply.

Exclusion Criteria:

- Participation in any investigational drug trial within the 30 days preceding the

Screening Visit (SV).

- 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 that has not resolved within the 2

weeks preceding the Screening Visit (SV).

- Currently requires treatment with ╬▓2-adrenergic receptor antagonists or non-selective

╬▓-receptor blocking agents.

- History of life-threatening asthma that is defined for this protocol as an asthma

episode that required intubation.

- Any asthma exacerbation requiring oral corticosteroids within 3 months of the

Screening Visit (SV). A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit (SV).

- Historical or current evidence of any clinically significant non-asthmatic acute or

chronic condition including.

- Other exclusion criteria apply.

Locations and Contacts

Teva Investigational Site 10077, Birmingham, Alabama, United States

Teva Investigational Site 10079, Phoenix, Arizona, United States

Teva Investigational Site 10569, Costa Mesa, California, United States

Teva Investigational Site 10053, Fountain Valley, California, United States

Teva Investigational Site 10065, Huntington Beach, California, United States

Teva Investigational Site 10572, Huntington Beach, California, United States

Teva Investigational Site 10075, Los Angeles, California, United States

Teva Investigational Site 10061, Roseville, California, United States

Teva Investigational Site 10066, San Diego, California, United States

Teva Investigational Site 10068, Denver, Colorado, United States

Teva Investigational Site 10069, Denver, Colorado, United States

Teva Investigational Site 10058, Miami, Florida, United States

Teva Investigational Site 10060, Miami, Florida, United States

Teva Investigational Site 10064, Ormond Beach, Florida, United States

Teva Investigational Site 10071, Savannah, Georgia, United States

Teva Investigational Site 10073, Wichita, Kansas, United States

Teva Investigational Site 10070, Owensboro, Kentucky, United States

Teva Investigational Site 10063, Bethesda, Maryland, United States

Teva Investigational Site 10571, Gaithersburg, Maryland, United States

Teva Investigational Site 10067, Wheaton, Maryland, United States

Teva Investigational Site 10072, St. Louis, Missouri, United States

Teva Investigational Site 10050, Missoula, Montana, United States

Teva Investigational Site 10057, Raleigh, North Carolina, United States

Teva Investigational Site 10051, Cincinnati, Ohio, United States

Teva Investigational Site 10078, Sylvania, Ohio, United States

Teva Investigational Site 10054, Oklahoma City, Oklahoma, United States

Teva Investigational Site 10568, Oklahoma City, Oklahoma, United States

Teva Investigational Site 10055, Tulsa, Oklahoma, United States

Teva Investigational Site 10056, Medford, Oregon, United States

Teva Investigational Site 10076, Medford, Oregon, United States

Teva Investigational Site 10684, Charleston, South Carolina, United States

Teva Investigational Site 10570, Spartanburg, South Carolina, United States

Teva Investigational Site 10049, Live Oak, Texas, United States

Teva Investigational Site 10052, San Antonio, Texas, United States

Teva Investigational Site 10685, Waco, Texas, United States

Teva Investigational Site 10059, Fairfax, Virginia, United States

Teva Investigational Site 10074, Puyallup, Washington, United States

Teva Investigational Site 10062, Tacoma, Washington, United States

Additional Information

Starting date: December 2012
Last updated: May 28, 2015

Page last updated: August 23, 2015

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