Phase 3
Completed N=773
Efficacy, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov NCT01513460 ↗Enrolled (actual)
773
Serious AEs
6.7%
Results posted
Jan 2015
Primary outcomePrimary: Change From Baseline in Mean Trough Forced Expiratory Volume in 1 Second (FEV1) (NVA237 Versus Tiotropium) — 0.095; 0.102 liters
Summary
This study will assess the efficacy, tolerability and safety of NVA237 compared to tiotropium when added on to fluticasone/salmeterol in patients with chronic obstructive pulmonary disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Trough Forced Expiratory Volume in 1 Second (FEV1) (NVA237 Versus Tiotropium) |
0.095; 0.102 | — |
| SECONDARY Change From Baseline in Mean Trough FEV1 (Flu/Sal Versus NVA237/Tiotropium+Flu/Sal) |
-0.010; 0.077; -0.002; 0.088; -0.012; 0.088 | — |
| SECONDARY Change From Baseline in Mean Trough FEV1 |
0.077; 0.077; -0.010; 0.084; 0.092; -0.002 | — |
| SECONDARY Change From Baseline in Total Score of the St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) After 12 Weeks of Treatment |
-2.806; -3.902; -0.652 | — |
| SECONDARY Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Use |
2.191; 2.093; 2.908 | — |
| SECONDARY Mean Percentage of Nights With 'no Nighttime Awakenings' |
0.834; 0.816; 0.823 | — |
| SECONDARY Mean Percentage of Days With Performance of Usual Activities |
0.934; 0.946; 0.903 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with Moderate to Severe COPD (Stage II or Stage III) according to the GOLD 2010 guideline
- Current or ex-smokers who have a smoking history of at least 10 pack years
- Qualifying FEV1 at Visit 2 (day -7)
Exclusion Criteria
- Patients with a history of asthma or a history of high blood eosinophil count (>600/mm³)
- Patients with concomitant pulmonary disease
- Patients with lung lobectomy or lung volume reduction or lung transplantation
- Patients with α-1 antitrypsin deficiency
- Patients who have had live attenuated vaccinations within 30 days prior to screening visit or during run-in period
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01513460). 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.