Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease
Treatments nva237 50µg once daily, tiotropium 18µg once daily, placebo, nva237 placebo + tiotropium placebo.
Phase phase 3
Sponsor Novartis Pharmaceuticals
Start date April 2012
End date February 2014
Trial size 763 participants
Trial identifier NCT01513460, CNVA237AAU01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Fluticasone/Salmeterol). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus fluticasone / salmeterol 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all patients were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
nva237 50µg once daily
NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI)
nva237 placebo + tiotropium placebo.
Tiotropium 18 μg o.d. delivered via a proprietary inhalation device
(Active Comparator)
Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Fluticasone/Salmeterol). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus fluticasone / salmeterol 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all patients were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
tiotropium 18µg once daily
Tiotropium 18 μg o.d. delivered via a proprietary inhalation device
nva237 placebo + tiotropium placebo.
Tiotropium 18 μg o.d. delivered via a proprietary inhalation device
(Placebo Comparator)
Placebo (NVA237 placebo + Tiotropium placebo + Fluticasone/Salmeterol). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus fluticasone / salmeterol 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all patients were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
placebo
NVA237 placebo + Tiotropium placebo.
nva237 placebo + tiotropium placebo.
Tiotropium 18 μg o.d. delivered via a proprietary inhalation device

Primary Outcomes

Measure
Mean trough forced expiratory volume in 1 second (FEV1)
time frame: 12 weeks

Secondary Outcomes

Measure
Mean trough forced expiratory volume in 1 second (FEV1)
time frame: Weeks 4 and 8
Total score of the St George's Respiratory Questionnaire for COPD patients (SGRQ-C) After 12 weeks of treatment
time frame: Week 12
Daily rescue Medication Use (number of puffs) Over the study duration (Baseline to Week 12)
time frame: 12 weeks
Percentage of nights with 'no nighttime awakenings' over 12 weeks (Baseline to Week 12)
time frame: 12 weeks
Performance of usual activities
time frame: 12 weeks
Adverse Events, Death, and Serious or Clinically Significant Adverse Events or Related Discontinuations
time frame: 12 weeks and 30 day follow-up (for SAE - 7 days for AE)

Eligibility Criteria

Male or female participants at least 40 years old.

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.

Additional Information

Official title A Multicenter, Randomized, Blinded, Active-controlled, Parallel-group Study to Compare the Efficacy, Tolerability and Safety of NVA237 Compared to Tiotropium Added on to Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Novartis.