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Evaluation of the Efficacy and Safety of QVA149 (110/50 μg o.d.) vs Tiotropium (18 µg o.d.) + Salmeterol/Fluticasone Propionate FDC (50/500 µg b.i.d.) in Patients With Moderate to Severe COPD

NCT02603393 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1053

Last updated 2019-04-29

Study results available
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Summary

This study will evaluate the efficacy and safety of QVA149 (110/50 μg o.d.) vs tiotropium (18 µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with moderate to severe COPD

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

QVA149

QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI

DRUG

Tiotropium

Tiotropium will be supplied as commercially available blisters, delivered via HandiHaler®

DRUG

Salmeterol/fluticasone

Salmeterol/fluticasone propionate dry inhalation powder delivered via Accuhaler™

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
2015-11-20
Primary Completion
2017-07-18
Completion
2017-07-18

Countries

  • Argentina
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Croatia
  • Czechia
  • Denmark
  • Estonia
  • Germany
  • Greece
  • Hungary
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Romania
  • Serbia
  • Slovakia
  • Spain
  • United Kingdom

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 NCT02603393 on ClinicalTrials.gov