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Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients

NCT01382368 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-11-15

No results posted yet for this study

Summary

* Pulmonary diseases are increasingly important causes of morbidity and mortality in the modern world.
* Sildenafil, an orally administered a phosphodiesterase type 5 (PDE-5) inhibitor, targets the nitric oxide (NO) pathway. The drug was first approved for the treatment of Pulmonary Arterial Hypertension (PAH) in 2005.
* The aim of the suggested study is to examine the acute effect of oral intake of sildenafil on exercise tolerance and functional capacity in Chronic Obstructive Pulmonary Disease (COPD), Idiopathic pulmonary fibrosis (IPF) and post Pneumonectomy patients.
* The investigators hypothesize that oral ingestion of sildenafil prior the exercise may enhance exercise tolerance and improve function in COPD, IPF and post Pneumonectomy patients.
* Patients and Methods:

Sixty chronic lung disease patients males and females (aged 30 to 90 years) 20 COPD (GOLD III-IV) \[9, 39\] , 20 IPF and 20 post Pneumonectomy patients will be recruit to this study.

* All subjects will carried out two maximal cardiopulmonary exercise tests (CPET) on bicycle ergometer in different days; 60 min after intake of placebo and 60 min after intake of 100 mg sildenafil (Pfizer, Sandwich, UK), in random order.
* In first meeting prior exercise test at rest standard pulmonary function test, diffusion of CO, TLC and RV will be measured. In addition, Doppler Echocardiography and blood samples for NT-proBNP will be taken prior and post each CPET.
* After 15-20 minute of passive recovery post exercise test all patients will perform 3 short functional tests including 6 minute walk test to assess functional capacity.

Conditions

Interventions

DRUG

Sildenafil

Acute single dose of 100 mg of sildenafil. Oral intake in tablet form.

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Mordechai R Kramer, M.D · Rabin Medical Center, Belinson Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-11-30
Completion
2013-09-30

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01382368 on ClinicalTrials.gov