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Tadalafil for Respiratory Symptoms in COPD with Pulmonary Hypertension
NCT05937854Phase 2
Key facts
- Status
- Recruiting
- Start
- Apr 2024
- Primary completion
- Mar 2029
- Countries
- 1
- Sponsor
- VA Office of Research & Development
- Modality
- Small Molecules
- Drugs
- tadalafil
- Conditions
- chronic obstructive pulmonary disease (COPD)pulmonary hypertension (PH)
01
Overview
Phase 2, randomised, double-blind trial in chronic obstructive pulmonary disease (COPD) and pulmonary hypertension (PH) comparing Tadalafil with Placebo (2 arms). Primary endpoint: Severity of patient-reported dyspnea at 6 months. Started Apr 2024; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Tadalafil
Tadalafil 20mg po QD
Placebo
Placebo po QD
03
Who it enrols
Outpatients aged 35-89 with COPD, documented pulmonary hypertension, and dyspnea, on a long-acting bronchodilator. Excludes patients with severe heart, liver, or kidney disease, systemic hypotension, or those taking nitrates, other PDE-5 inhibitors, or strong CYP inducers/inhibitors.
04
Endpoints
Primary
Severity of patient-reported dyspnea
Secondary
Physical activity assessed by objective daily step count
Functional exercise capacity
Time to clinically important deterioration
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