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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01382368
Recruitment Status : Unknown
Verified November 2012 by Mordechai Kremer, Rabin Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : June 27, 2011
Last Update Posted : November 15, 2012
Information provided by (Responsible Party):
Mordechai Kremer, Rabin Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Idiopathic Pulmonary Fibrosis Drug: Sildenafil Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients
Study Start Date : September 2011
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : September 2013

Arm Intervention/treatment
Experimental: Sildenafil Drug: Sildenafil
Acute single dose of 100 mg of sildenafil. Oral intake in tablet form.

Primary Outcome Measures :
  1. VO2 Peak [ Time Frame: 2-30 days between exercise tests ]
  2. 6 min walk test [ Time Frame: 2-30 days between exercise tests ]
    Distance walked in 6 min test

  3. Functional Tests [ Time Frame: 2-30 days between exercise tests ]
    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 :
  1. Pulmonary Arterial Pressure [ Time Frame: 2-30 days between exercise tests ]
  2. NT-pro-BNP [ Time Frame: 2-30 days between exercise tests ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01382368

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

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Responsible Party: Mordechai Kremer, Prof. Mordechai R. Kramer, Head of Pulmonary Institute, Rabin Medical Center Identifier: NCT01382368     History of Changes
Other Study ID Numbers: RMCBH116278 CTIL
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: November 15, 2012
Last Verified: November 2012

Keywords provided by Mordechai Kremer, Rabin Medical Center:
Post Pneumonectomy Patients

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Respiratory Tract Diseases
Lung Diseases, Interstitial
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents