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

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT01424813

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

158

Starts

2012-12-01

Expected to finish

2013-11-01

Last updated by the study team

2015-06-26

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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