A 26-week Treatment, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of NVA237 (50 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease

Novartis Pharmaceuticals1 site in 1 country460 target enrollmentMarch 2012

ConditionsChronic Obstructive Pulmonary Disease (COPD)

InterventionsNVA237 Placebo

DrugsNVA237 Placebo

Overview

Phase: Phase 3
Intervention: NVA237
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Novartis Pharmaceuticals
Enrollment: 460
Locations: 1
Primary Endpoint: Trough Forced Expiratory Volume in One Second (FEV1)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

June 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

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 \< 80% of the predicted normal, and post-bronchodilator FEV1/FVC \< 0.7 at Visit 2 (Day -14) (post means: record FEV1 and FVC 45 min after administering ipratropium).
•Symptomatic patients, according to daily electronic diary data between Visit 2 (Day -14) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3

Exclusion Criteria

•With a history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
•Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count \> 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
•Other protocol-defined inclusion/exclusion criteria may apply.

Arms & Interventions

NVA237

NVA237 50 µg once daily delivered via a single dose dry powder inhaler

Intervention: NVA237

Placebo

Placebo once daily delivered via a single dose dry powder inhaler

Intervention: Placebo

Outcomes

Primary Outcomes

Trough Forced Expiratory Volume in One Second (FEV1)

Time Frame: 12 weeks

Baseline FEV1 was defined as the average of the -45 min and -15 min FEV1 values taken on day 1 prior to the first dose of study medication. Trough FEV1 was defined as the mean of the post-dose 23 h 15 min and the 23 h 45 min FEV1 values. FEV1 was measured using central spirometry according to ATS/ERS standardization. Trough FEV1 was analyzed using a MIXED model for the full analysis set population. The model contained treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation of short acting bronchodilator, FEV1 45 min post inhalation of short acting bronchodilator and baseline inhaled corticosteroids (ICS) use as covariates.

Secondary Outcomes

Standardized FEV1 Area Under the Curve (AUC(5 Min-4 h)) Post-dose(Day 1, week 12, week 26)
Number of Moderate and Severe COPD Exacerbations(26 weeks)
Transition Dyspnea Index (TDI) Score(Baseline, week 12, week 26)
Peak FEV1(Day 1, week 12, week 26)
Change From Baseline in Chronic Obstructive Pulmonary Disease (COPD) Symptoms (Cough, Wheezing, Shortness of Breath, Sputum Volume, Sputum Color and Night Time Awakenings)(Baseline, 26 weeks)
Change From Baseline in Daily Rescue Medication Use (Number of Puffs)(Baseline, 26 weeks)
Time to First Moderate or Severe COPD Exacerbation(26 weeks)
24h Trough FEV1(Day 1, Week 26)
FEV1 and Forced Vital Capacity (FVC)(Day 1 at 5, 15, 30 minutes (min) and 1 hour (h) post dose; days 2, 86, 184 at 23 (h) 15 min and 23 h 45 min post dose; days 29, 85, 183 at -45 and -15 min pre-dose and 5, 15, and 30 min post dose)
The Total Score of the St George's Respiratory Questionnaire (SGRQ)(Week 12, week 26)