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

• Status: Completed
• Trial end date: 2018-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laval University
• Collaborator: Novartis
• Treatments: Glycopyrrolate; Tiotropium Bromide

Criteria

Inclusion Criteria:

1. Age > 50 years

2. Smoking history > 10 packs/year

3. FEV1 30 - 79% of predicted and FEV1/FVC < 70% (GOLD 2-3)

4. FRC > 120 % predicted

5. Borg dyspnea score > 3 during the 3-min constant rate shuttle walking test at V3

Exclusion Criteria:

1. Respiratory exacerbation within the 2 months preceding the study

2. Current diagnostic of asthma

3. Significant O2 desaturation (SpO2 < 85%) at rest or during exercise

4. Presence of another pathology that could influence exercise tolerance

5. Use of home oxygen