Phase 3
N=822
A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT01005901 ↗Enrolled (actual)
822
Serious AEs
8.0%
Results posted
Apr 2012
Primary outcome: Primary: Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks — 1.408; 1.301 Liters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Glycopyrronium bromide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in 1 Second (FEV1) at 12 Weeks |
1.408; 1.301 | — |
| SECONDARY Transition Dyspnea Index (TDI) Focal Score After 26 Weeks of Treatment |
1.84; 0.80 | — |
| SECONDARY Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 26 Weeks of Treatment |
39.50; 42.31 | — |
| SECONDARY Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During 26 Weeks of Treatment |
NA; NA | — |
| SECONDARY Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (Baseline to Week 26) |
-1.21; -0.75 | — |
| SECONDARY FEV1 at Each Time-point on Day 1 and Week 26 |
1.388; 1.295; 1.435; 1.292; 1.472; 1.299 | — |
| SECONDARY Forced Vital Capacity (FVC) at Each Time-point on Day 1 and Week 26 |
2.887; 2.675; 2.943; 2.660; 2.948; 2.637 | — |
| SECONDARY FEV1 Area Under the Curve (AUC) (5 Min - 12 Hour) at Day 1, Week 12 and Week 26 |
1.475; 1.320; 1.433; 1.284; 1.445; 1.238 | — |
| SECONDARY FEV1 Area Under Curve (AUC) (5 Min - 23 Hour 45 Min) at Week 12 and Week 26 |
1.401; 1.268; 1.412; 1.213 | — |
| SECONDARY Trough FEV1 and FVC at Day 1 and Week 26 |
1.414; 1.309; 1.387; 1.275; 2.901; 2.705 | — |
| SECONDARY Change in 24-hourly Mean Heart Rate at Day 1, Week 12 and Week 26 |
-1.77; -1.28; -1.99; -1.70; -4.40; -2.60 | — |
| SECONDARY Number of Participants With Adverse Events, Death, and Serious or Clinically Significant Adverse Events or Related Discontinuations |
317; 174; 3; 3; 41; 24 | — |
| SECONDARY Rate of Moderate or Severe COPD Exacerbations Over the 26 Week Treatment Period |
0.43; 0.59 | — |
| SECONDARY Percentage of Nights With no Nighttime Awakenings Over the 26 Week Treatment Period |
55.96; 54.37 | — |
| SECONDARY Percentage of Days With no Daytime Symptoms Over the 26 Week Treatment Period |
5.70; 5.78 | — |
| SECONDARY Percentage of Days Able to Perform Usual Daily Activities Over the 26 Week Treatment Period |
40.31; 35.19 | — |
| SECONDARY Mean Daily Total Symptom Score Over the 26 Week Treatment Period |
-1.54; -1.18 | — |
Summary
A study to assess the safety, tolerability and efficacy of NVA237 versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:
- Smoking history of at least 10 pack-years
- Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value
- Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%
Exclusion Criteria
- Patients who have had a lower respiratory tract infection within 6 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 comorbid 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 tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01005901). 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.