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

May 2, 2011
November 13, 2012
September 2011
November 2012   (final data collection date for primary outcome measure)
  • 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.
  • VO2 Peak [ Time Frame: 5-10 days between exercise tests ] [ Designated as safety issue: No ]
  • 6 min walk test [ Time Frame: 5-10 days between exercise tests ] [ Designated as safety issue: No ]
    Distance walked in 6 min test
  • Functional Tests [ Time Frame: 5-10 days between exercise tests ] [ Designated as safety issue: No ]
    1. 30 seconds chair stand test- number of repetitions in 30 sec
    2. Chair sit-and- reach test (trunk and hamstring flexibility) - number of cm on ruler
    3. Back stretch (shoulder and back flexibility) - number of cm on ruler 4.8-ft-up-and -go (agility and coordination)- number of sec that takes to complete the task.
Complete list of historical versions of study NCT01382368 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Pulmonary Arterial Pressure [ Time Frame: 5-10 days between exercise tests ] [ Designated as safety issue: No ]
  • NT-pro-BNP [ Time Frame: 5-10 days between exercise tests ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients
Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients
  • 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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Chronic Obstructive Pulmonary Disease
  • Idiopathic Pulmonary Fibrosis
Drug: Sildenafil
Acute single dose of 100 mg of sildenafil. Oral intake in tablet form.
Experimental: Sildenafil
Intervention: Drug: Sildenafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
60
September 2013
November 2012   (final data collection date for primary outcome measure)

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).
Both
30 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01382368
RMCBH116278 CTIL
Yes
Mordechai Kremer, Rabin Medical Center
Rabin Medical Center
Not Provided
Principal Investigator: Mordechai R Kramer, M.D Rabin Medical Center, Belinson Hospital
Rabin Medical Center
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP