Effects of Dual Bronchodilator Treatment on Cardiopulmonary Interactions in COPD

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03425617
• Date of registration: 01/02/2018
• Prospective Registration: No
• Primary sponsor: Queen's University
• Public title: Effects of Dual Bronchodilator Treatment on Cardiopulmonary Interactions in COPD
• Scientific title: Effects of Dual Bronchodilator Treatment (Tiotropium + Olodaterol Respimat) on Cardiopulmonary Interactions in Hyperinflated Patients With COPD
• Date of first enrolment: January 1, 2017
• Target sample size: 25
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03425617
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Canada

Contacts

• Name: J Alberto Neder, Prof
• Affiliation: Queen'sUniversity/Kingston General Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age =50 years;

2. Male or female gender;

3. Long-term history of active smoking;

4. Signs and symptoms of COPD with adequate treatment according to the GOLD
recommendations for at least 3 months (1);

5. A modified MRC dyspnea score =2 or a Baseline Dyspnea Index =8;

6. Resting lung hyperinflation as demonstrated by inspiratory capacity <80% predicted or
functional residual capacity >120% predicted at Visit 1;

7. Objective evidence of dynamic hyperinflation (a decrease in inspiratory capacity from
rest >200 mL)(24,25) and peak exercise dyspnea (breathing discomfort) = leg discomfort
scores during the incremental cardiopulmonary exercise test at Visit 1;

8. A positive "volume" response (=200 mL increase in inspiratory capacity) to a
bronchodilator (400µg salbutamol) at Visit 1

9. Ability to perform all study procedures and provide/sign informed consent.

Exclusion Criteria:

1. Asthma or other concomitant pulmonary disease;

2. Use of oral steroids in the preceding month;

3. Orthopedic/rheumatological limitation precluded cycling;

4. Type I or non-controlled type II diabetes mellitus or other endocrine diseases;

5. Unstable angina, life-threatening cardiac arrhythmias, use of an implantable
defibrillator;

6. Myocardial infarction within the previous 6 months;

7. History of long QT syndrome (or prolonged corrected QT interval (>450 ms during
screening);

8. Clinically significant ECG abnormality;

9. History of exercise-induced syncope;

10. Any contraindication for exercise testing;

11. Inability to understand and cooperate with the procedures.



Age minimum: 50 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease

Intervention(s)

Drug: Tiotropium + Olodaterol

Other: PLACEBO

Primary Outcome(s)

Blood Flow Index (BFI) [Time Frame: 1 day]

Secondary Outcome(s)

Tlim [Time Frame: 1 day]

Cardiac output [Time Frame: 1 day]

Exercise dyspnea [Time Frame: 1 day]

Inspiratory reserve volume [Time Frame: 1 day]

Inspiratory capacity [Time Frame: 1 day]

Muscle oxygenation [Time Frame: 1 day]

Secondary ID(s)

6018318

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Boehringer Ingelheim