Crossover Study to Evaluate the Efficacy, Safety and Tolerability of Different Doses of Indacaterol in Patients With Persistent Asthma

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

The purpose of this study is to determine the efficacy of indacaterol 55µg once daily (and 27.5 µg twice) in QVA149 compared to 75 µg indacaterol monotherapy.

Key facts

Study ID

NCT01959412

Run by

Novartis Pharmaceuticals

People needed

91

Starts

2013-11-01

Expected to finish

2014-03-01

Last updated by the study team

2015-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Asthma for at least 6 months, using inhaled corticosteroid for at least one month, foreced breath test less than below the normal value of the general population, -show an immediate improvement in breathing when given albuterol

You may not qualify if…

• patients who have smoked in the past 6 months or are currently smoking, including those who smoked more than a pack of cigarettes a day for at least 10 years, -patients who have a history of life-threatening asthma, -patients who have had an astham attack, in the last 6 weeks, requiring use of systemic steroids, hospitalization, or ER visit, -patients who have had a respiratory tract infection or worsening asthma between screening or run-in periods, patients requring use of other asthma-related drugs during the trial, other protocol-defined inclusion/exclusion may apply

Where it is running

• Novartis Investigative Site — Huntington Beach, California, United States
• Novartis Investigative Site — Los Angeles, California, United States
• Novartis Investigative Site — Mission Viejo, California, United States
• Novartis Investigative Site — Centennial, Colorado, United States
• Novartis Investigative Site — North Dartmouth, Massachusetts, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Skillman, New Jersey, United States
• Novartis Investigative Site — Raleigh, North Carolina, United States
• Novartis Investigative Site — Medford, Oregon, United States
• Novartis Investigative Site — Portland, Oregon, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — El Paso, Texas, United States

Full record on ClinicalTrials.gov

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