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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

Sponsored by Teva Branded Pharmaceutical Products, R&D Inc.

Phase Quota
Phase 2

The study will measure the change in lung function in subjects with asthma after inhaling from either of two inhalers: albuterol in a dry powder inhaler or placebo.

Study Start Date: December 2012

Estimated Completion Date: December 2013

Specialties: Pulmonology: Asthma/Atopy Allergy/Immunology: Cardiovascular/Pulm,Derm Allergy/Immunology

Interventions

  • Drug: Albuterol dry powder
  • Drug: Placebo
  • Drug: Albuterol Spiromax®

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 SV
  • Currently requires treatment with ß2-adrenergic receptor antagonists or non-selective ß-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 SV. A subject must not have had any hospitalization for asthma within 6 months prior to the SV
  • Historical or current evidence of any clinically significant non-asthmatic acute or chronic condition including.
  • Other exclusion criteria apply

Study Locations And Contact Information

  • Teva Investigational Site 10570, Spartanburg South Carolina
  • Teva Investigational Site 10076, Medford Oregon
  • Teva Investigational Site 10059, Fairfax Virginia
  • Teva Investigational Site 10058, Miami Florida
  • Teva Investigational Site 10069, Denver Colorado
  • Teva Investigational Site 10067, Wheaton Maryland
  • Teva Investigational Site 10051, Cincinnati Ohio
  • Teva Investigational Site 10055, Tulsa Oklahoma
  • Teva Investigational Site 10072, St. Louis Missouri
  • Teva Investigational Site 10079, Phoenix Arizona
  • Teva Investigational Site 10073, Wichita Kansas
  • Teva Investigational Site 10074, Puyallup Washington
  • Teva Investigational Site 10070, Owensboro Kentucky
  • Teva Investigational Site 10050, Missoula Montana
  • Teva Investigational Site 10066, San Diego California
  • Teva Investigational Site 10071, Savannah Georgia
  • Teva Investigational Site 10571, Gaithersburg Maryland
  • Teva Investigational Site 10685, Waco Texas
  • Teva Investigational Site 10049, Live Oak Texas
  • Teva Investigational Site 10569, Costa Mesa California
  • Teva Investigational Site 10078, Sylvania Ohio
  • Teva Investigational Site 10060, Miami Florida
  • Teva Investigational Site 10062, Tacoma Washington
  • Teva Investigational Site 10064, Ormond Beach Florida
  • Teva Investigational Site 10063, Bethesda Maryland
  • Teva Investigational Site 10053, Fountain Valley California
  • Teva Investigational Site 10075, Los Angeles California
  • Teva Investigational Site 10068, Denver Colorado
  • Teva Investigational Site 10052, San Antonio Texas
  • Teva Investigational Site 10057, Raleigh North Carolina
  • Teva Investigational Site 10684, Charleston South Carolina
  • Teva Investigational Site 10572, Huntington Beach California
  • Teva Investigational Site 10065, Huntington Beach California
  • Teva Investigational Site 10056, Medford Oregon
  • Teva Investigational Site 10061, Roseville California
  • Teva Investigational Site 10077, Birmingham Alabama
  • Teva Investigational Site 10568, Oklahoma City Oklahoma
  • Teva Investigational Site 10054, Oklahoma City Oklahoma

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