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Ultibro® Versus Spiriva® Alone to Reduce Exertional Dyspnea in Patients With Moderate to Severe COPD

NCT02567214 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-06-07

No results posted yet for this study

Summary

The investigators will compare the reduction in Borg dyspnea score during the 3-min constant rate shuttle walking test after 3 weeks of indacaterol 110 µg/Glycopyrronium 50 µg (Ultibro®) versus Tiotropium 18 µg (Spiriva®) alone in patients with moderate to severe COPD.

Conditions

Interventions

DRUG

Ultibro®

The intervention in this arm is the Ultibro®. To keep the patients blinded on which treatement they are taking they will use the two devices but in this arm the Ultibro will be delivered and the Spiriva will be a placebo. We will measure the exertional dyspnea after 21 days of treatment.

DRUG

Spiriva®

The intervention in this arm is the Spiriva®. To keep the patients blinded on which treatement they are taking they will use the two devices but in this arm the Ultibro will be a placebo and the Spiriva will be delivered. We will measure the exertional dyspnea after 21 days of treatment.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Laval University

    lead OTHER

Principal Investigators

  • François Maltais, MD · Laval University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
51 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-11-30
Completion
2018-11-30

Countries

  • Canada

Study Locations

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Diseases
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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 NCT02567214 on ClinicalTrials.gov