A Multicener, Randomised, Double-blind, Placebo-controlled Study, to Assess the Long Term Safety of 52 Weeks Treatment With QVA149 (110 ug Indacaterol/50ug Glycopyrrolate) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Overview
- Phase
- Phase 3
- Intervention
- QVA149
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 339
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events, Serious Adverse Events or Death
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The study is designed to provide long-term safety data for QVA149 in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Investigators
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
Arms & Interventions
QVA149
110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
Intervention: QVA149
Placebo
Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants With Adverse Events, Serious Adverse Events or Death
Time Frame: 52 weeks + Follow-up (Up to Day 394)
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.
Secondary Outcomes
- Pre-dose FEV1(52 weeks)
- Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period(52 weeks)
- Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period(52 weeks)
- Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period(52 weeks)
- Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period(52 weeks)