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

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

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

Key facts

Study ID

NCT01747629

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

160

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
• 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

You may not qualify if…

• 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.

Where it is running

• Teva Investigational Site 10225 — Costa Mesa, California, United States
• Teva Investigational Site 10250 — Encinitas, California, United States
• Teva Investigational Site 10230 — Huntington Beach, California, United States
• Teva Investigational Site 10255 — Palmdale, California, United States
• Teva Investigational Site 10231 — Rancho Mirage, California, United States
• Teva Investigational Site 10252 — Riverside, California, United States
• Teva Investigational Site 10242 — Rolling Hills Estates, California, United States
• Teva Investigational Site 10238 — San Diego, California, United States
• Teva Investigational Site 10243 — San Jose, California, United States
• Teva Investigational Site 10247 — Miami Lakes, Florida, United States
• Teva Investigational Site 10239 — Tallahassee, Florida, United States
• Teva Investigational Site 10234 — Tampa, Florida, United States
• Teva Investigational Site 10253 — Bangor, Maine, United States
• Teva Investigational Site 10257 — Baltimore, Maryland, United States
• Teva Investigational Site 10254 — White Marsh, Maryland, United States
• Teva Investigational Site 10235 — Fall River, Massachusetts, United States
• Teva Investigational Site 10236 — North Dartmouth, Massachusetts, United States
• Teva Investigational Site 10226 — Minneapolis, Minnesota, United States
• Teva Investigational Site 10233 — Minneapolis, Minnesota, United States
• Teva Investigational Site 10241 — St Louis, Missouri, United States
• Teva Investigational Site 10229 — Bellevue, Nebraska, United States
• Teva Investigational Site 10227 — Rochester, New York, United States
• Teva Investigational Site 10244 — Charlotte, North Carolina, United States
• Teva Investigational Site 10248 — Cincinnati, Ohio, United States
• Teva Investigational Site 10249 — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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