Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma With Steady State Pharmacokinetics

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

Summary

The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax® versus placebo in subjects with persistent asthma.

• 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

• At least 12 years of age at screening

• General good health

• Persistent asthma for ≥3 months, with an FEV1 50-80% predicted and ≥15% reversibility

• Taking inhaled corticosteroids at a stable dose (≤ equivalent of 500mcg of fluticasone propionate/day) for at least 4 weeks prior to the Screening Visit.

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

• Other inclusion criteria apply

Exclusion Criteria:

• A known hypersensitivity to albuterol or any of the excipients in the formulations.

• History of a respiratory infection or disorder that has not resolved within 1 week preceding the Screening Visit (SV).

• 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 SV. A subject must not have had any hospitalization for asthma within 6 months prior to the SV.

• Hospitalization due to asthma exacerbation 2 or more times in the past year

• Initiation of immunotherapy or dose escalation during the study period

• Other exclusion criteria apply.