Phase 3
Completed N=1,001
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 NCT01712516 ↗Enrolled (actual)
1,001
Serious AEs
3.6%
Results posted
Jul 2015
Primary outcomePrimary: Primary: Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h)) — 0.234; 0.122; 0.155; -0.028 Liters
Summary
This study will assess the efficacy, safety and tolerability of indacaterol maleate/glycopyrronium bromide in patients with moderate to severe airflow limitation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary: Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h)) |
0.234; 0.122; 0.155; -0.028 | — |
| SECONDARY Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score |
-7.5; -5.9; -6.0; -1.1 | — |
| SECONDARY Percentage of Participants With a Clinically Important Improvement of at Least 4 Units in the SGRQ Total Score |
59.2; 56.8; 51.5; 34.5 | — |
| SECONDARY Change From Baseline in Trough FEV1 |
0.208; 0.111; 0.132; 0.010; 0.216; 0.138 | — |
| SECONDARY Change From Baseline in Pre-dose Trough FEV1 |
0.193; 0.100; 0.108; -0.027 | — |
| SECONDARY Change From Baseline in FEV1 |
0.117; 0.076; 0.072; -0.001; 0.160; 0.090 | — |
| SECONDARY Change From Baseline in FVC |
0.245; 0.175; 0.158; -0.006; 0.318; 0.185 | — |
| SECONDARY 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) |
0.213; 0.101; 0.174; 0.019; 0.187; 0.090 | — |
| SECONDARY Transitional Dyspnea Index (TDI) Focal Score |
2.88; 1.98; 1.88; 0.85 | — |
| SECONDARY Secondary: Change From Baseline in Mean Daily Number of Puffs of Rescue Medication |
-2.19; -2.05; -1.78; -1.04 | — |
| SECONDARY Secondary: Change From Baseline in Mean Total Daily Symptom Score, Mean Daytime Total Symptom Score and Mean Nighttime Total Symptom Score |
-1.34; -1.22; -1.09; -0.61; -1.16; -1.05 | — |
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 (NCT01712516). 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.