Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH

Conditions

• Chronic Obstructive Pulmonary Disease
• Dyspnea
• Pulmonary Hypertension

Eligibility Criteria

Sex

ALL

Age

35 Years - 89 Years

Healthy Volunteers

Not accepted

Interventions

• Tadalafil — DRUG
  one or 2 encapsulated tablets of encapsulated tadalafil (20MG) po QD
• Placebo — DRUG
  one or two encapsulated tablets of placebo po QD

Study Details

The investigators will study whether the drug tadalafil improves shortness of breath in 126 Veterans with Chronic Obstructive Pulmonary Disease (COPD) and high blood pressure in the lungs. The investigators will also assess whether tadalafil improves quality of life, home daily physical activity, exercise endurance, the frequency of acute flares of COPD, blood pressure in the lungs, and lung function. Veterans who enroll in the trial will be allocated by chance to either active tadalafil or an inactive identical capsule (placebo). Neither the Veteran nor the investigator will know whether the Veteran is taking tadalafil or placebo. Veterans will be followed closely in clinic or by telephone at 1, 2, 3, 4, 5, and 6 months, with attention to side effects and safety. At 1,3, and 6 months the investigators will repeat the questionnaires and testing of blood pressures in the lung and lung function. The investigators anticipate that the results of this study will determine whether tadalafil improves shortness of breath when added to usual medications for COPD.

Key Dates

Start date

Apr 1, 2024

Status verified

May 2026

Primary completion

Mar 1, 2029

Completion

Mar 1, 2029

Study Design

Enrollment

126 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Encapsulated placebo one or 2 encapsulated tablets po QD
• Active Comparator: tadalafil
  one or 2 encapsulated tablets of encapsulated tadalafil (20MG) po QD

Primary Outcome Measure

severity of patient-reported dyspnea [ Time Frame: 6 months ]

Central Contacts

• Sharon I Rounds, MD
  (401) 273-7100
  [email protected]
• Ronald H Goldstein, MD
  (857) 203-6578
  [email protected]

Locations (5)

Find similar trials in Aurora, CO

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