Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorUniversity of Alberta

About this trial

Chronic obstructive pulmonary disease (COPD) is a condition characterized by airway obstruction. Patients with COPD experience significant shortness of breath on exertion. The mechanisms responsible for shortness of breath on exertion are well understood in moderate and severe COPD, but, are poorly understood in mild COPD where symptoms appear disproportionate to the degree of airway obstruction.

Mild COPD patients show an exaggerated breathing response to exercise, determined by the breathing response to carbon dioxide production (V̇E/V̇CO2). Recent work suggests that the increased V̇E/V̇CO2 during exercise in mild COPD is secondary to increased deadspace (i.e. lung regions with ventilation but no perfusion) and/or ventilation/perfusion (V̇A/Q) inequality (poor matching of ventilation to perfusion). Researchers have proposed that the increased deadspace or V̇A/Q inequality is secondary to pulmonary vascular dysfunction and hypoperfusion of the pulmonary capillaries.

Recently, we have shown that inhaled nitric oxide, a potent dilator of pulmonary vasculature, reduces shortness of breath and V̇E/V̇CO2, and improves exercise capacity in mild COPD. This preliminary finding suggests that pulmonary vascular dysfunction is an important contributor to exercise intolerance in mild COPD. Here, we aim to test whether sildenafil, an oral pulmonary vasodilator, can improve exercise tolerance and shortness of breath in mild COPD.

Eligibility criteria

Qualifiers

Post bronchodilator Forced Expiratory Volume in one second (FEV1) to Forced Vital Capacity (FVC) ratio (FEV1/FVC) below the lower limit of normal

FEV1 >30% of predicted (lower limit of GOLD severe COPD classification)

No diagnosis of COPD

Post bronchodilator Forced Expiratory Volume in one second (FEV1) to Forced Vital Capacity (FVC) ratio (FEV1/FVC) above the lower limit of normal

Disqualifiers

Absolute contraindication to exercise testing or an orthopedic condition that may limit exercise testing.

Pre-existing cardiac conditions (heart failure, congenital heart defect, valvular disease) that may limit exercise testing

A diagnosis of pulmonary hypertension preceding COPD

Current phosphodiesterase type-5 inhibitor, nitrate, opioid, azole antifungal, macrolide antibiotic, protease inhibitor, alpha blocker, riociguat, mifepristone or rifamycin use.

Trial design

Treatments tested in this trial

  • Sildenafil Citrate
  • Placebo

Treatment groups

160 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Alberta

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator