Phase 3
Completed N=934
The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT01574651 ↗Enrolled (actual)
934
Serious AEs
5.8%
Results posted
Apr 2014
Primary outcomePrimary: St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Non-inferiority Analysis). — 44.70; 45.68; 41.30; 43.19 Score on a scale
Summary
This study will assess the efficacy and safety of QVA149 compared to tiotropium plus formoterol in patients with moderate to severe COPD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Non-inferiority Analysis). |
44.70; 45.68; 41.30; 43.19 | — |
| SECONDARY St. George's Respiratory Questionnaire (SGRQ-C) Total Score After 26 Weeks of Treatment (Superiority Analysis). |
44.70; 45.68; 41.30; 43.19 | — |
| SECONDARY Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment. |
1.34; 0.87 | — |
| SECONDARY Percent of Participants With at Least One Exacerbation Requiring Systemic Corticosteroids and/or Antibiotics Over 26 Weeks |
10.9; 13.3 | — |
| SECONDARY Percent of Participants With at Least One Exacerbation Requiring Hospitalization |
2.1; 2.4 | — |
| SECONDARY Time- Event Analysis, Number of Participants With at Least One COPD Exacerbation (Moderate or Severe) During the Treatment Period |
62; 70 | — |
| SECONDARY Trough FEV1 at Baseline and Week 26 |
1.329; 1.313; 1.495; 1.409 | — |
| SECONDARY FEV1 30 Min After the Morning Dose at Baseline and Week 26 |
1.517; 1.495; 1.605; 1.565 | — |
| SECONDARY Symptoms Score Reported by the Patients Using Part I "Symptoms" of SGRO-C |
64.10; 64.29; 58.31; 60.16 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female adults aged ≥ 40 yrs
- Patients with moderate to severe chronic obstructive pulmonary disease (GOLD 2010 guidelines)
- Smoking history of at least 10 pack years
- Post-bronchodilator FEV1 15 h a day)
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01574651). 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.