Phase 3
Completed N=511
Long Term Safety Study of NVA237 vs QAB149 in COPD Patients
Source: ClinicalTrials.gov NCT01697696 ↗Enrolled (actual)
511
Serious AEs
13.2%
Results posted
Mar 2016
Primary outcomePrimary: Percentage of Participants Reporting Safety and Tolerability in Terms of Adverse Event (AE) Reporting Rate — 77.3; 77 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Reporting Safety and Tolerability in Terms of Adverse Event (AE) Reporting Rate |
77.3; 77 | — |
| SECONDARY Time to Treatment Discontinuation |
NA; 388 | — |
| SECONDARY 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 |
0.056; 0.060 | — |
| SECONDARY Change From Baseline in Pre-dose Forced Expiratory Volume (FEV1) in One Second at All Post Baseline Timepoints |
0.104; 0.118; 0.123; 0.138; 0.098; 0.101 | — |
| SECONDARY Change From Baseline in Pre-dose Forced Vital Capacity (FVC) at All Post-baseline Timepoints |
0.191; 0.170; 0.217; 0.194; 0.168; 0.140 | — |
| SECONDARY Change From Baseline in COPD Symptoms |
17.4; 18.0; 6.0; 5.1; 5.4; 8.5 | — |
| SECONDARY Change From Baseline in Mean Daily Number of Puffs of Rescue Medication |
-1.16; -1.79; -0.71; -1.05; -0.52; -0.73 | — |
| SECONDARY Time to First COPD Exacerbation (Moderate or Severe). |
NA; NA | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01697696). 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.