Phase 3
N=460
Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease (COPD)
Bottom Line
View on ClinicalTrials.gov: NCT01566604 ↗Enrolled (actual)
460
Serious AEs
6.8%
Results posted
Aug 2014
Primary outcome: Primary: Trough Forced Expiratory Volume in One Second (FEV1) — 1.204; 1.063 Liters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NVA237 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in One Second (FEV1) |
1.204; 1.063 | — |
| SECONDARY Transition Dyspnea Index (TDI) Score |
2.8; 1.6; 3.0; 2.0 | — |
| SECONDARY Change From Baseline in Daily Rescue Medication Use (Number of Puffs) |
-0.77; -0.55 | — |
| SECONDARY 24h Trough FEV1 |
1.230; 1.109; 1.195; 1.059 | — |
| SECONDARY FEV1 and Forced Vital Capacity (FVC) |
1.199; 1.112; 1.245; 1.116; 1.265; 1.111 | — |
| SECONDARY Peak FEV1 |
1.376; 1.183; 1.347; 1.140; 1.308; 1.112 | — |
| SECONDARY Standardized FEV1 Area Under the Curve (AUC(5 Min-4 h)) Post-dose |
1.311; 1.117; 1.286; 1.080; 1.243; 1.046 | — |
| SECONDARY Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptoms (Cough, Wheezing, Shortness of Breath, Sputum Volume, Sputum Color and Night Time Awakenings) |
-1.16; -0.85; -0.21; -0.12; -0.24; -0.20 | — |
| SECONDARY Time to First Moderate or Severe COPD Exacerbation |
NA; NA | — |
| SECONDARY Number of Moderate and Severe COPD Exacerbations |
0.2; 0.3 | — |
| SECONDARY The Total Score of the St George's Respiratory Questionnaire (SGRQ) |
32.35; 37.39; 31.02; 35.94 | — |
Summary
This study will assess of the efficacy and safety of a once-daily, 50µg inhalation of NVA237 in moderate to severe chronic obstructive pulmonary disease (COPD) patients over 26 weeks treatment.
Eligibility Criteria
Inclusion Criteria
- Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
- With moderate to severe stable COPD (Stage II or Stage III).
- Current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack- years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years).
- Post-bronchodilator FEV1 ≥30% and 600/mm3 (at Visit 2) or onset of symptoms prior to age 40 years. Patients without asthma but who have a blood eosinophil count >600/mm3 at Visit 2 are excluded.
- Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless confirmed by imaging to be no longer active) or clinically significant bronchiectasis, sarcoidosis and interstitial lung disorder.
- Patients with lung lobectomy or lung volume reduction or lung transplantation.
- Patients with known history and diagnosis of α-1 antitrypsin deficiency.
- Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 6 weeks prior to Visit 1 Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1.
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01566604). 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.