Phase 2
N=154
Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease (COPD)
Bottom Line
View on ClinicalTrials.gov: NCT00570778 ↗Enrolled (actual)
154
Serious AEs
0.4%
Results posted
Feb 2013
Primary outcome: Primary: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7 — 1.512; 1.389; 1.395; 1.286 Liters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- indacaterol/glycopyrrolate (Drug); indacaterol (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 7 |
1.512; 1.389; 1.395; 1.286 | — |
| SECONDARY Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7 |
1.610; 1.473; 1.457; 1.317 | — |
| SECONDARY Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events |
2; 0; 0; 0; 39; 31 | — |
Summary
This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD.
Eligibility Criteria
Inclusion Criteria
- Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
- Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines 2006.
- Patients who have smoking history of at least 10 pack years.
- Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥30% and 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency department for a COPD exacerbation or as result of their airways disease in the 6 weeks prior to screening.
- Patients who have had a respiratory tract infection within 6 weeks prior to screening.
- Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
- Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 400/mm3.
- Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
- Patients with uncontrolled Type I and Type II diabetes.
- History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years.
- Patients who are contraindicated for or who have shown an untoward reaction to inhaled anticholinergic agents.
- Patients with a history of long QT syndrome or whose QTc interval (Fridericia method) measured at screening is prolonged (>450 ms for males or >470 ms for females).
- Patients with a history of untoward reactions to sympathomimetic amines, inhaled medication or any component thereof, or any of the study drugs or drugs with similar chemical structures.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00570778). 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.