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.
Sponsor:
Information provided by (Responsible Party):
Mordechai Kremer, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01382368
First received: May 2, 2011
Last updated: November 13, 2012
Last verified: November 2012
  Purpose
  • 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.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Idiopathic Pulmonary Fibrosis
Drug: Sildenafil
Phase 4

Study Type: Interventional
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:


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 ]
    1. 30 seconds chair stand test- number of repetitions in 30 sec
    2. 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 ]

Estimated Enrollment: 60
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)
Arms Assigned Interventions
Experimental: Sildenafil Drug: Sildenafil
Acute single dose of 100 mg of sildenafil. Oral intake in tablet form.

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with severe COPD GOLD stage III- IV, FEV1 30-50% or less of predicted values, greater shortness of breath, reduced exercise capacity, repeated excretions and\ or with chronic respiratory failure [9, 39].
  2. IPF patients diagnosed essentially according to the American Thoracic and European Respiratory Societies (ATS-ERS) by clinical diagnostic criteria of: (a) High-resolution computed tomography (HRCT) demonstrating a pattern of "confident" or "possible" IPF (b) Abnormal pulmonary physiology with evidence of restriction and/or impaired gas exchange (can exist during exercise alone) (c) Exclusion of other known causes of interstitial lung disease (e.g.: connective tissue disease, environmental exposure,etc.)[31].
  3. Patients post Pneumonectomy more than 6 month from the amputation surgery for any diagnosis (Cancer, Trauma, and Infection- Bronchiectasis).

Exclusion Criteria:

  1. Patients with known sensitivity or contraindications to phosphodiesterase 5 (PDE-5) inhibitor therapies will be excluding from the study.
  2. Thromboembolic disease will be excluded by pulmonary CT-angiography or perfusion scan.
  3. Patients with a history of left-sided heart failure will be excluded.
  4. Patients will also exclude if they are on regular treatment with nitrates or PDE-5 inhibitors (Sildenafil, Tadalafil, Vardenafil).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01382368

Locations
Israel
Pulmonary Institute, Rabin Medical Center, Beilinson Hospital
Petach Tikva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Mordechai R Kramer, M.D Rabin Medical Center, Belinson Hospital
  More Information

No publications provided

Responsible Party: Mordechai Kremer, Prof. Mordechai R. Kramer, Head of Pulmonary Institute, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01382368     History of Changes
Other Study ID Numbers: RMCBH116278 CTIL
Study First Received: May 2, 2011
Last Updated: November 13, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Post Pneumonectomy Patients
IPF
COPD

Additional relevant MeSH terms:
Fibrosis
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Pulmonary Fibrosis
Lung Diseases, Obstructive
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014