Does Sildenafil Increase Exercise Performance in Air Pollution?

Pulmonary Hypertension Clinical Trial

Official title:

Decreased Pulmonary Artery Pressure by Oral Sildenafil Injection During Exercise in Air Pollution Increases Exercise Performance.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00808912
• Other study ID #: MU2007-028
• Status: Completed
• Phase: N/A
• First received: December 12, 2008
• Last updated: June 22, 2010
• Start date: December 2008
• Est. completion date: February 2010

Study information

• Verified date: June 2010
• Source: Marywood University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine if the ingestion of a standard dose of sildenafil enhances the athletic performance of competitive athletes when exercising in a high pollutant environment verses a low air pollutant environment.

Description:

This study will evaluate effects of sildenafil on exercise performance while breathing high levels of emission exhaust ultrafine and fine particulate matter. Exercise performance will be measured by work accumulation (total kJ) during a 6-min maximal effort cycle ergometer ride (CER) done immediately after 30 min cycling at 75% of 6 min mean watts determined from familiarization trial. Peak oxygen consumption, cardiac output, pulmonary artery pressure, diffusion capacity(DLco), and SaO2 will be determined for each trial. Blood and urine will be analyzed for sildenafil using LC/MS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• non-asthmatic

• asthmatic

• active participants in endurance sports.

Exclusion Criteria:

• history of high blood pressure

• history of heart disease

• pulmonary arterial hypertension

• pulmonary emboli

• diagnosis of moderate to severe asthma (FEV1 <75% predicted)

• pregnant or lactating

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Air Pollution
• Exercise Performance
• Hypertension, Pulmonary
• Pulmonary Artery Pressure
• Pulmonary Hypertension

Intervention

Drug:
• sildenafil
sildenafil 50 mg ingested orally 1 hour prior to exercise testing

Other:
• placebo
matching placebo for sildenafil 50 mg to be ingested orally 1 hour prior to exercise testing.

Locations

Country	Name	City	State
United States	Marywood University	Scranton	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Marywood University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	That a decrease in exercise performance subsequent to emissions particle inhalation will be blunted by oral ingestion of 50 mg sildenafil prior to a 6-min maximal accumulation test (total kJ)on a cycle ergometer.		Cycle ergometer testing will be done one hour after administration of sildenafil or matching placebo.	No
Secondary	That the decreased VO2 peak and decreased exercise performance from emissions inhalation will be the result of pulmonary hypertension causing decreased stroke volume.		Pulmonary artery pressure will be measured before and immediately post exercise.	No
Secondary	That plasma and urine sildenafil and metabolites will be measurable by liquid chromatography mass spectrometry (LC/MS) 6 h post ingestion.		Blood and urine samples will be collected at 1, 3, 1nd 6 hours post exercise testing.	No