Status:
COMPLETED
Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Asthma
Eligibility:
All Genders
12-70 years
Phase:
PHASE2
Brief Summary
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 corticoster...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
2283 Patients enrolled
Trial Details
Trial ID
NCT00941798
Start Date
July 1 2009
End Date
May 1 2011
Last Update
August 31 2012
Active Locations (146)
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1
Novartis Investigator Site
Birmingham, Alabama, United States, 35209
2
Novartis Investigator Site
Buena Park, California, United States, 90620
3
Novartis Investigator Site
Encinitas, California, United States, 92024
4
Novartis Investigator Site
Fullerton, California, United States, 92835