Phase 3
N=246
The Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT01490125 ↗Enrolled (actual)
246
Serious AEs
2.6%
Results posted
Dec 2013
Primary outcome: Primary: Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo — 7.34; 7.33; 0.98; -0.38 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- QVA149 (Drug); Tiotropium (Drug); Placebo to QVA149 (Drug); Placebo to tiotropium (Drug); Salbutamol/albuterol (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo |
7.34; 7.33; 0.98; -0.38 | — |
| SECONDARY Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Tiotropium |
7.34; 7.31; 0.98; 0.47 | — |
| SECONDARY Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 5min-4h After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium |
1.564; 1.496; 1.352; 1.636; 1.529; 1.302 | — |
| SECONDARY Standardized Forced Vital Capacity (FVC) Area Under the Curve (AUC) 5min-4 Hrs After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium |
3.340; 3.249; 3.020; 3.393; 3.269; 2.957 | — |
| SECONDARY Change From Baseline in The Capacity of Daily Living During the Morning (CDLM) Score Averaged Over 6 Weeks of Treatment |
0.09; 0.08; -0.01 | — |
| SECONDARY Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Used Over the 6 Weeks of Treatment |
-1.02; -0.57; 0.41 | — |
Summary
This study assessed the effect of QVA149 on patient-reported dyspnea in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.
Eligibility Criteria
Inclusion Criteria
- Patients with moderate to severe stable chronic obstructive pulmonary disease
- Smoking history of 10 pack years
- Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) between 30 - 80%
- Patients must be able to use computer mouse and display
- mMRC grade>2
Exclusion Criteria
- Patients with a history of long QT syndrome
- Patients with Type I or uncontrolled Type II diabetes
- Patients who have had a COPD exacerbation or respiratory tract infection within 6 weeks prior to screening
- Patients with any history of asthma
- Patients with pulmonary lobectomy, lung volume reduction surgery, or lung transplantation
- Patients with concomitant pulmonary disease
- Patients requiring long term oxygen therapy (>15 h a day)
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01490125). 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.