Phase 3
Completed N=1,042
A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.
Source: ClinicalTrials.gov NCT01727141 ↗Enrolled (actual)
1,042
Serious AEs
3.8%
Results posted
Jun 2015
Primary outcomePrimary: Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h)) — 0.211; 0.117; 0.112; -0.021 Liter
Summary
This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to severe airflow limitation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h)) |
0.211; 0.117; 0.112; -0.021 | — |
| SECONDARY Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score |
-6.4; -4.6; -4.8; -2.7 | — |
| SECONDARY Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score |
57.3; 48.0; 46.1; 39.0 | — |
| SECONDARY Change From Baseline in Trough FEV1 |
0.187; 0.109; 0.112; 0.015; 0.201; 0.120 | — |
| SECONDARY Change From Baseline in Pre-dose Trough FEV1 |
0.161; 0.083; 0.061; -0.035 | — |
| SECONDARY Change From Baseline in FEV1 |
0.111; 0.071; 0.065; 0.009; 0.146; 0.088 | — |
| SECONDARY Change From Baseline in FVC |
0.234; 0.175; 0.136; 0.009; 0.283; 0.200 | — |
| SECONDARY Change From Baseline in Standardized FEV1 AUC (0-4 h), FEV1 AUC (4-8h), FEV1 AUC (8-12h) and FEV1 AUC (0-12 h) |
0.194; 0.096; 0.158; 0.028; 0.178; 0.096 | — |
| SECONDARY Transitional Dyspnea Index (TDI) Focal Score |
1.94; 1.30; 1.48; 0.71 | — |
| SECONDARY Change From Baseline in Mean Daily Number of Puffs of Rescue Medication |
-2.22; -1.72; -1.65; -1.00 | — |
| SECONDARY Change From Baseline in Mean Total Daily Symptom Score, Mean Daytime Total Symptom Score and Mean Nighttime Total Symptom Score |
-1.30; -0.97; -0.99; -0.52; -1.17; -0.85 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients that have signed informed consent and are >/= 40 years of age.
- Patients with stable COPD according to GOLD 2011.
- Patients with a post-bronchodilator FEV1 of >/= 30% and 450 ms for males and females) and confirmed by a central assessor. (These patients should not be re-screened.)
- Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102. (These patients should not be re-screened.)
- Patients with a history of malignancy of any organ system, treated or untreated, within the last five years.
- Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention.
- Patients who had a COPD exacerbation within 6 weeks prior to screening.
- Patients who have a respiratory tract infection within 4 weeks prior to screening.
- Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.
- Patients with a history of asthma. 8. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to age 40 years.
- Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.
- Patients with concomitant pulmonary disease.
- Patients with a diagnosis of alpha-1 anti-trypsin deficiency.
- Patients with active pulmonary tuberculosis.
- Patients in the active phase of a pulmonary rehabilitation programme.
- Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01727141). 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.