Phase 2
Completed N=1,518
Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma
Source: ClinicalTrials.gov NCT00941798 ↗Enrolled (actual)
1,518
Serious AEs
4.9%
Results posted
Jun 2012
Primary outcomePrimary: Time to First Serious Asthma Exacerbation — 13.3; 13.4 months
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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Serious Asthma Exacerbation |
13.3; 13.4 | — |
| SECONDARY Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death. |
2; 6 | — |
| SECONDARY Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids |
124; 171 | — |
| SECONDARY Number of Patients With at Least One Asthma Worsening Post-baseline |
533; 637 | — |
| SECONDARY Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit |
0.06; -0.07 | — |
| SECONDARY Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit |
0.09; -0.04; 0.12; -0.05; 0.13; -0.06 | — |
| SECONDARY Change From Baseline in Forced Vital Capacity (FVC) at Final Visit |
-0.03; -0.11; -0.03; -0.13; -0.01; -0.13 | — |
| SECONDARY Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period |
0.43; 0.00; 0.27; -0.15 | — |
| SECONDARY Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime |
22.3; 18.4; 27.1; 19.5; 23.6; 17.3 | — |
| SECONDARY Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime |
-1.22; -0.94; -0.50; -0.39; -0.46; -0.36 | — |
| SECONDARY Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime |
29.1; 17.9; 23.6; 13.8; 24.6; 14.5 | — |
| SECONDARY Change From Baseline in Asthma Control Questionnaire (ACQ) at Final Visit |
-0.55; -0.32 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00941798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.