A Randomized, Multi-center, Parallel Group, Double Blind, Study to Assess the Safety of QMF Twisthaler® (500/400 µg) and Mometasone Furoate Twisthaler® (400 µg) in Adolescent and Adult Patients With Persistent Asthma
| City: |
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North Dartmouth |
| State: |
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Massachusetts |
| Zip Code: |
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02747 |
| Conditions: |
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Asthma |
| Purpose: |
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Study CQMF149A2210 will evaluate 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 that is approved for use in the treatment of asthma. The objective
of this safety trial is to asses the effect of treatment on the incidence of serious asthma
exacerbations, defined as asthma related hospitalization and/or intubation and/or death.
This is an event driven trial.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Patients with a documented diagnosis of persistent asthma and who are currently
treated with or qualify for treatment with both ICS and LABA combination
- Patients demonstrating an increase in FEV1 of ≥ 12% or ≥ 200 mLs within 30 minutes
after administration of β2-agonist (SABA)
- Patients with an FEV1 ≥ 50% of predicted normal
Exclusion Criteria:
- Patients with a previous diagnosis of COPD
- Patients who have had an asthma attack/exacerbation requiring
hospitalization/emergency room visit or respiratory tract infection within 1 month
prior to randomization
- Patients who have 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
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| NCT ID: |
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NCT00941798 |
| Primary Contact: |
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Study Director
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Phone: 862-778-8300
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| Backup Contact: |
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N/A |
| Location Contact: |
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North Dartmouth, Massachusetts 02747
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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