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Phase 2 N=36 Randomized Triple-blind Treatment

Tadalafil for Pulmonary Hypertension Due to Chronic Lung Disease

Pulmonary Hypertension · Chronic Obstructive Pulmonary Disease (COPD)

Enrolled (actual)
36
Serious AEs
22.2%
Results posted
Mar 2021
Primary outcome: Primary: Change in 6 Minute Walk Test — 7.00; 16.60; 16.00; 4.90 Meters walked in 6 minutes

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Tadalafil (Drug); placebo (Drug)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
Aug 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in 6 Minute Walk Test
7.00; 16.60; 16.00; 4.90; -18.00; 8.93
SECONDARY
Maximum VO2
13.6
SECONDARY
Pulmonary Vascular Resistance
4.26; 2.69
SECONDARY
Mean Pulmonary Artery Pressure
33.00; 29.00
SECONDARY
Tricuspid Annular Plane Excursion (TAPSE)
2.08; 2.12
SECONDARY
St. George's Respiratory Questionnaire, Dyspnea and Health Related Quality of Life
49.34; 44.64
SECONDARY
N-type Brain Natriuretic Peptide (BNP) Concentration
37.50; 47.81
SECONDARY
Resting Hypoxemia
SECONDARY
Exercise-induced Hypoxemia

Summary

The functional, social, and economic burden of chronic obstructive lung disease (COPD) on the healthcare system is extraordinary. COPD is the fourth leading cause of death in the United States, and some estimates attribute up to $33.2 billion in health care costs to COPD-associated morbidity and mortality annually. The burden of COPD to the VA Healthcare system parallels these findings. According to the VA HSR&D Health Economics Resource Center, COPD ranks 5th among the 40 most common chronic clinical conditions in the U.S. Veteran patient population, is responsible for >14,000 VA hospital admission annually, and increases by $1,051/patient the total annual health care cost burden on the VA Healthcare system. Importantly, COPD is associated with frequent emergency room visitation and/or hospitalization patients. Pulmonary hypertension is a common co-morbid condition that worsen morbidity and mortality in patients with COPD. This study will examine the potential for tadalafil, a phosphodiesterase type-5 (PDE-5) inhibitor to improve functional status by decreasing pulmonary hypertension. Results from this study are expected to define the potential use of PDE-5 inhibitors in COPD-induced pulmonary hypertension. If successful, this treatment option may improve quality of life and outcomes for the large number of Veterans afflicted with PH due to COPD.

Eligibility Criteria

Inclusion Criteria

  • Male and female U.S. Veteran patients 40-85 years old, with Gold Stage II COPD by pulmonary function testing (FEV1/FVC 40mmHg. To confirm the presence of PH, a right-heart catheterization will be performed, with subjects randomized to treatment only if catheterization shows a:
  • mPAP >25 mm Hg
  • PVR >2.5 Wood units
  • pulmonary artery capillary wedge pressure 18 mm Hg or less at rest
  • PH belonging to the following subgroup of the updated Dana Point Clinical Classification:
  • Group 3 (PH associated with lung disease and/or hypoxemia) specifically, Group 3.1 (chronic obstructive pulmonary disease [COPD]) as the major criteria. Patients may also have minor clinical features associated with 3.2 (Interstitial disease) (such as mild fibrosis on high resolution chest CT, but total lung capacity>80% predicted) and 3.3 (sleep disordered breathing) (AHI 15)
  • Patients with any coagulopathy
  • Patients requiring nitrate therapy for any clinical indication
  • Patients with an active prescription for pulmonary vasodilator medication other than oxygen
  • Patients with a history of nonarteritic anterior ischemic optic neuropathy
  • Contraindication to tadalafil use including allergy to:
  • any PDE-5 inhibitor
  • anatomical deformations of the penis
  • sickle cell anemia
  • multiple myeloma
  • leukemia
  • bleeding disorders
  • active peptic ulcer disease
  • retinitis pigmentosa or other retinal disorders.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01862536). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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