Phase 3
Completed N=523
QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT01315249 ↗Enrolled (actual)
523
Serious AEs
5.2%
Results posted
Aug 2013
Primary outcomePrimary: Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 — 1.69; 1.56 liters
Summary
The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 |
1.69; 1.56 | — |
| SECONDARY Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours |
1.71; 1.59 | — |
| SECONDARY Forced Vital Capacity at All-time Points (Week 12) |
3.37; 3.16; 3.37; 3.17; 3.44; 3.20 | — |
| SECONDARY Forced Vital Capacity at All-time Points (Week 26) |
3.32; 3.13; 3.33; 3.12; 3.42; 3.17 | — |
| SECONDARY Focal Score of the Transitional Dyspnea Index (TDI) |
2.03; 1.45; 2.36; 1.60 | — |
| SECONDARY Total Score of the St. George's Respiratory Questionnaire (SGRQ-C) |
36.74; 36.03; 35.45; 36.68 | — |
| SECONDARY Mean Change From Baseline in Daily Number of Puffs of Rescue Medication |
-2.18; -1.90; -2.32; -1.93 | — |
| SECONDARY Change From Baseline in Symptom Scores Reported Using the Ediary |
-1.08; -1.17; -1.28; -1.24 | — |
| SECONDARY Inspiratory Capacity (IC) at All-time Points (12 Weeks) |
2.39; 2.31; 2.55; 2.42; 2.54; 2.43 | — |
| SECONDARY Inspiratory Capacity (IC) at All-time Points (26 Weeks) |
2.25; 2.22; 2.41; 2.34; 2.38; 2.35 | — |
| SECONDARY Number of Participants With Adverse Events |
143; 159; 0; 1; 13; 14 | — |
Eligibility Criteria
Inclusion Criteria
- Smoking history of at least 10 pack years
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2009)
- Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) >40% and < 80% of the predicted normal value and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <70%
Exclusion Criteria
- Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the last year.
- Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
- 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 (within last 5 years)
- Patients with a history of certain cardiovascular co-morbid conditions
Data sourced from ClinicalTrials.gov (NCT01315249). 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.