Efficacy of NVA237 (50 μg o.d) Using Tiotropium (5μg μg o.d) as Active Control in COPD Patients.

Phase 3

Withdrawn

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Tiotropium Respimat®; Drug: NVA237

• Registration Number: NCT01837927
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study will assess the Efficacy of NVA237 (50 μg o.d) using tiotropium (5μg μg o.d) as active control in COPD patients.

Detailed Description

A 52-week treatment, multicenter, randomized, open-label, parallel-group study to assess the efficacy of NVA237 (50μg once daily) using Tiotropium (5μg once daily) as an active control in Brazilian patients with moderate to severe Chronic Obstructive Pulmonary Disease.

Study Timeline

• Study First Submitted: 2013-04-18
• Study First Submitted QC: 2013-04-18
• Study First Posted: 2013-04-23
• Study Start: 2014-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-19
• Last Update Posted: 2016-08-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tiotropium	Tiotropium Respimat®	Tiotropium 5μg inhaled via the Respimat® device once daily
NVA237	NVA237	NVA237 inhaled via the Breezhaler® device once daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)	Baseline and 12 weeks after treatment.	Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.

Secondary Outcome Measures

Name	Time	Method
Safety and tolerance of NVA237	52 weeks	All AEs and SAEs will be reported
Forced Expiratory Volume in 1 Second (FEV1) at weeks 24 and 52	pre-dose at weeks 24 and 52 of study treatment	Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.
Change From Baseline in Forced Vital Capacity (FVC)	Days 1 and 7, weeks 12, 24 and 52 of study treatment	Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
Forced Expiratory Volume in 1 Second (FEV1) at day 7 and weeks 12, 24 and 52	30 and 60 minutes post-dose on the 7th day of study treatment and at weeks 12, 24 and 52	Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.
FEV1 AUC 0-4h	05, 30, 60 minutes and 4 hours post-dose at days 1, 7 and week 12	Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.
Forced Expiratory Volume in 1 Second (FEV1) at day 1	30 and 60 minutes post-dose on the first day of study treatment.	Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. A positive change from baseline in FEV1 indicates improvement in lung function.