Status:
COMPLETED
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
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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 β2-adrenergic receptor antagonists or non-selective β-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.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT01424813
Start Date
December 1 2012
End Date
November 1 2013
Last Update
June 26 2015
Active Locations (38)
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1
Teva Investigational Site 10077
Birmingham, Alabama, United States
2
Teva Investigational Site 10079
Phoenix, Arizona, United States
3
Teva Investigational Site 10569
Costa Mesa, California, United States
4
Teva Investigational Site 10053
Fountain Valley, California, United States