NCT01697696CompletedPhase 3
A Multi-center, Randomized, Double-blind, 52-week Study to Assess the Safety of NVA237 Compared to QAB149 in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Have Moderate to Severe Airflow Limitation
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 511
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Reporting Safety and Tolerability in Terms of Adverse Event (AE) Reporting Rate
Study Overview
Brief Summary
The purpose of the study is to provide long term safety data of NVA237. This study will assess the safety and tolerability of a single dose strength of NVA237.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female patients with COPD according to GOLD 2011 who have signed informed consent.
- •Patients with airflow limitation of 30-80% post-bronchodilator FEV1 at run-in.
- •Current or ex-smokers with a smoking history of at least 10 pack years
- •Patients with a mMRC score of at least 2 at run-in.
Exclusion Criteria
- •Patients contraindicated for muscarinic antagonist agents and beta-2 agonists
- •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 requiring long term oxygen therapy prescribed for more than 12 hr per day.
- •Patients with a history of asthma.
- •Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to 40 years of age.
- •Patients with a blood eosinophil count of greater than 600 mm/3 during run-in
- •Patients with concomitant pulmonary disease
- •Patients with a history of certain cardiovascular co-morbid conditions
- •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
Arms & Interventions
NVA237 dose 1
Experimental
NVA237 dose 1
Intervention: NVA237 (Drug)
Long-acting beta 2-agonist (LABA)
Active Comparator
QAB149
Intervention: Long-acting beta 2-agonist (LABA) (Drug)
Long-acting beta 2-agonist (LABA)
Active Comparator
QAB149
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Reporting Safety and Tolerability in Terms of Adverse Event (AE) Reporting Rate
Time Frame: 52 weeks
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
- Time to Treatment Discontinuation(52 Weeks)
- Change From Baseline in Pre-dose Forced Expiratory Volume (FEV1) in One Second at All Post Baseline Timepoints(-45 min and -15 minutes baseline and at Week 52)
- Change From Baseline in Pre-dose Forced Vital Capacity (FVC) at All Post-baseline Timepoints(-45 min and -15 minutes baseline and at Week 52)
- Change From Baseline in COPD Symptoms(52 weeks)
- Change From Baseline in Mean Daily Number of Puffs of Rescue Medication(52 weeks)
- Change From Baseline in Mean Forced Expiratory Volume (Average of the Two FEV1 Measurements 45 and 15 Minutes Pre-dose) in One Second at Week 52(-45 min and -15 minutes baseline and at Week 52)
- Time to First COPD Exacerbation (Moderate or Severe).(52 weeks)
Investigators
Study Sites (1)
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