Phase 3
Completed N=2,144
A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT01202188 ↗Enrolled (actual)
2,144
Serious AEs
5.1%
Results posted
May 2013
Primary outcomePrimary: Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment — 1.45; 1.38; 1.36 Liters
Summary
The purpose of this study is to provide pivotal efficacy and safety data for QVA149 in patients with moderate to severe COPD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment |
1.45; 1.38; 1.36 | — |
| SECONDARY Transitional Dyspnea Index (TDI) Focal Score at Week 26 |
2.72; 1.63 | — |
| SECONDARY St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 26 |
37.01; 40.02 | — |
| SECONDARY Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Over 26 Weeks |
-1.88; -0.92 | — |
| SECONDARY Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149, QAB149 and NVA237 Compared to Placebo |
1.45; 1.38; 1.36; 1.25 | — |
| SECONDARY Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149 Compared to Tiotropium |
1.46; 1.39 | — |
| SECONDARY Baseline Transitional Dyspnea Index (BDI/TDI) Focal Score at Week 12 and Week 26 |
6.45; 6.28; 6.21; 6.43; 6.53; 2.44 | — |
| SECONDARY Percentage of Patients With a Clinically Important Improvement of at Least 1 Point in TDI Focal Score After 26 Weeks of Treatment |
68.1; 64.6; 63.7; 59.2; 57.5 | — |
| SECONDARY St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 and 26 Weeks of Treatment |
37.56; 38.55; 39.40; 39.94; 41.55; 37.01 | — |
| SECONDARY Percentage of Patients With a Clinically Important Improvement From Baseline of at Least 4 Units in the SGRQ Total Score After 26 Weeks of Treatment |
63.7; 63.0; 60.5; 56.4; 56.6 | — |
| SECONDARY Percentage of Nights With "No Night Time Awakenings" Over 26 Weeks |
63.68; 62.48; 58.64; 60.00; 53.67 | — |
| SECONDARY Percentage of Days With "No Daytime Symptoms" Over 26 Weeks |
7.49; 9.17; 6.40; 5.54; 4.44 | — |
| SECONDARY Percentage of "Days Able to Perform Usual Daily Activities" Over 26 Weeks |
45.97; 40.94; 40.10; 37.52; 34.49 | — |
| SECONDARY Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication at Week 12 and Week 26 |
-1.82; -1.46; -1.22; -1.28; -0.83; -1.88 | — |
| SECONDARY Change From Baseline (BL) in the Daytime and Night Time Rescue Medication Use (Number of Puffs) Over 26 Weeks |
-1.11; -0.96; -0.75; -0.83; -0.58; -0.78 | — |
| SECONDARY Percentage of "Days With no Rescue Medication Use" Over 26 Weeks |
47.09; 44.81; 37.74; 36.51; 34.76 | — |
| SECONDARY Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours at Day 1 and Week 26 |
1.52; 1.46; 1.49; 1.44; 1.30; 1.57 | — |
| SECONDARY Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours at Day 1 and Week 26 |
1.50; 1.40; 1.42; 1.38; 1.24; 1.52 | — |
| SECONDARY Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes at Week 26 |
1.46; 1.35; 1.35; 1.36; 1.15 | — |
| SECONDARY 24 Hour Holter Monitoring in a Subset of Patients |
80.8; 79.9; 79.4; 78.9; 79.8; 78.6 | — |
| SECONDARY Rate of Moderate or Severe COPD Exacerbation |
0.46; 0.59; 0.52; 0.45; 0.75 | — |
| SECONDARY Percentage of Patients With at Least One Moderate or Severe COPD Exacerbation Over the 26 Week Treatment Period |
17.9; 21.6; 18.8; 17.7; 25.8 | — |
| SECONDARY Percentage of Participants With COPD Exacerbations Requiring Hospitalization or Treatment With Systemic Corticosteroids and/or Antibiotics But no Hospitalization |
2.1; 2.5; 1.9; 1.0; 3.0; 16.7 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female adults aged ≥40 yrs
- Smoking history of at least 10 pack years
- Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)
- Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%
Exclusion Criteria
- Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
- Patients with concomitant pulmonary disease
- Patients with a history of asthma
- Any patient with lung cancer or a history of lung cancer
- Patients with a history of certain cardiovascular co-morbid conditions
- Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
- Patients in the active phase of a supervised pulmonary rehabilitation program
- Patients contraindicated for inhaled anticholinergic agents and β2 agonists
- Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01202188). 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.