Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma

Completed · Phase 2

Conditions studied: Asthma

In brief

Study CQMF149A2210 evaluated the safety of QMF149 Twisthaler® 500/400 μg, a fixed dose combination of indacaterol 500 μg, a once daily β2 agonist, and mometasone furoate 400 μg, an inhaled corticosteroid (ICS) that is approved for use in the treatment of asthma. The objective of this safety trial was to assess the effect of treatment on the incidence of serious asthma exacerbations, defined as asthma related hospitalization and/or intubation and/or death. This was an event driven trial.

Key facts

Study ID

NCT00941798

Run by

Novartis Pharmaceuticals

People needed

2283

Starts

2009-07-01

Expected to finish

2011-05-01

Last updated by the study team

2012-08-31

Who can join

Age: 12 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with a documented diagnosis of persistent asthma and who were currently treated with or qualified for treatment with both ICS and long-acting beta2-agonist (LABA) combination
• Patients demonstrating an increase in forced expiration volume in 1 second (FEV1) of ≥ 12% or ≥ 200 mLs within 30 minutes after administration of short-acting beta2-agonist (SABA)
• Patients with an FEV1 ≥ 50% of predicted normal

You may not qualify if…

• Patients with a previous diagnosis of chronic obstructive pulmonary disease (COPD)
• Patients who had an asthma attack/exacerbation requiring hospitalization/emergency room visit or respiratory tract infection within 1 month prior to randomization
• Patients who had ever required ventilator support for respiratory failure
• Patients with diabetes Type I or uncontrolled diabetes Type II
• Patients with concomitant pulmonary disease
• Patients with certain cardiovascular co-morbid conditions
• Patients with any significant medical condition that might compromise patient safety, interfere with evaluation or preclude completion of the study
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigator Site — Buena Park, California, United States
• Novartis Investigator Site — Encinitas, California, United States
• Novartis Investigator Site — Fullerton, California, United States
• Novartis Investigator Site — Long Beach, California, United States
• Novartis Investigator Site — Los Angeles, California, United States
• Novartis Investigator Site — Orange, California, United States
• Novartis Investigator Site — Riverside, California, United States
• Novartis Investigator Site — San Diego, California, United States
• Novartis Investigator Site — San Jose, California, United States
• Novartis Investigator Site — San Mateo, California, United States
• Novartis Investigator Site — Vista, California, United States
• Novartis Investigator Site — Walnut Creek, California, United States
• Novartis Investigator Site — Denver, Colorado, United States
• Novartis Investigator Site — Engelwood, Colorado, United States
• Novartis Investigator Site — Lakewood, Colorado, United States
• Novartis Investigator Site — Wheat Ridge, Colorado, United States
• Novartis Investigator Site — Clearwater, Florida, United States
• Novartis Investigator Site — Clearwater, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigator Site — Port Charlotte, Florida, United States
• Novartis Investigator Site — Sarasota, Florida, United States
• Novartis Investigative Site — South Miami, Florida, United States
• Novartis Investigator Site — Tampa, Florida, United States
• Novartis Investigator Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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