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

NCT01382368 | Unknown Phase 4 DMC

• 1 other identifier: RMCBH116278 CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Idiopathic Pulmonary Fibrosis

Keywords

Post Pneumonectomy Patients; IPF; COPD

Outcome Measures

Primary Outcomes (3)

• VO2 Peak

  2-30 days between exercise tests

• 6 min walk test

  Distance walked in 6 min test

  2-30 days between exercise tests

• Functional 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.

  2-30 days between exercise tests

Secondary Outcomes (2)

• Pulmonary Arterial Pressure

  2-30 days between exercise tests

• NT-pro-BNP

  2-30 days between exercise tests

Study Arms (1)

Sildenafil

EXPERIMENTAL

Drug: Sildenafil

Interventions

Sildenafil DRUG

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

Sildenafil

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[9, 39\].
• Patients post Pneumonectomy more than 6 month from the amputation surgery for any diagnosis (Cancer, Trauma, and Infection- Bronchiectasis).

You may not qualify if:

• Patients with known sensitivity or contraindications to phosphodiesterase 5 (PDE-5) inhibitor therapies will be excluding from the study.
• Thromboembolic disease will be excluded by pulmonary CT-angiography or perfusion scan.
• Patients with a history of left-sided heart failure will be excluded.
• Patients will also exclude if they are on regular treatment with nitrates or PDE-5 inhibitors (Sildenafil, Tadalafil, Vardenafil).

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Pulmonary Institute, Rabin Medical Center, Beilinson Hospital

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Idiopathic Pulmonary Fibrosis

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pulmonary Fibrosis; Lung Diseases, Interstitial

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mordechai R Kramer, M.D

  Rabin Medical Center, Belinson Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Mordechai R. Kramer, Head of Pulmonary Institute

Study Record Dates

• First Submitted: May 2, 2011
• First Posted: June 27, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: September 1, 2013
• Last Updated: November 15, 2012

Record last verified: 2012-11

Locations

IL (1)