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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.
• Treatments: Albuterol

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 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.