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Long Term Safety and Tolerability of QVA149 Versus Tiotropium in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01285492 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2013-12-27

Study results available
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Summary

This is a 52-week treatment, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily QVA149 (indacaterol and NVA237 (\[glycopyrronium bromide\]) using tiotropium as an active control in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

QVA149

QVA149 (110 μg indacaterol / 50 μg glycopyrronium o.d.), delivered via Concept1

DRUG

Tiotropium

Tiotropium (18 μg o.d.), delivered via Handihaler®

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

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 NCT01285492 on ClinicalTrials.gov