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Efficacy, Tolerability and Safety of NVA237 in Patients With Chronic Obstructive Pulmonary Disease

NCT01513460 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 773

Last updated 2015-01-05

Study results available
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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.

Conditions

Interventions

DRUG

NVA237 50µg once daily

NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI)

DRUG

Tiotropium 18µg once daily

Tiotropium 18 μg o.d. delivered via a proprietary inhalation device

DRUG

Flu/Sal

Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device

DRUG

NVA237 placebo + Tiotropium placebo.

Tiotropium 18 μg o.d. delivered via a proprietary inhalation device

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01513460 on ClinicalTrials.gov