Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients
This study is enrolling participants by invitation only.
Rabin Medical Center
Information provided by (Responsible Party):
Mordechai Kremer, Rabin Medical Center
First received: May 2, 2011
Last updated: November 13, 2012
Last verified: November 2012
- 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.
Chronic Obstructive Pulmonary Disease
Idiopathic Pulmonary Fibrosis
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients|
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources: Idiopathic Pulmonary Fibrosis Usual Interstitial PneumoniaU.S. FDA Resources
Further study details as provided by Rabin Medical Center:
Primary Outcome Measures:
- VO2 Peak [ Time Frame: 2-30 days between exercise tests ] [ Designated as safety issue: No ]
- 6 min walk test [ Time Frame: 2-30 days between exercise tests ] [ Designated as safety issue: No ]Distance walked in 6 min test
- Functional Tests [ Time Frame: 2-30 days between exercise tests ] [ Designated as safety issue: No ]
- 30 seconds chair stand test- number of repetitions in 30 sec
- 8-ft-up-and -go (agility and coordination)- number of sec that takes to complete the task.
Secondary Outcome Measures:
- Pulmonary Arterial Pressure [ Time Frame: 2-30 days between exercise tests ] [ Designated as safety issue: No ]
- NT-pro-BNP [ Time Frame: 2-30 days between exercise tests ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Acute single dose of 100 mg of sildenafil. Oral intake in tablet form.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01382368
|Pulmonary Institute, Rabin Medical Center, Beilinson Hospital|
|Petach Tikva, Israel, 49100|
Sponsors and Collaborators
Rabin Medical Center
|Principal Investigator:||Mordechai R Kramer, M.D||Rabin Medical Center, Belinson Hospital|