Does Sildenafil Increase Exercise Performance in Air Pollution?

This study has been completed.
Sponsor:
Information provided by:
Marywood University
ClinicalTrials.gov Identifier:
NCT00808912
First received: December 12, 2008
Last updated: June 22, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Pulmonary Hypertension
Pulmonary Artery Pressure
Exercise Performance
Air Pollution
Drug: sildenafil
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Decreased Pulmonary Artery Pressure by Oral Sildenafil Injection During Exercise in Air Pollution Increases Exercise Performance.

Resource links provided by NLM:


Further study details as provided by Marywood University:

Primary Outcome Measures:
  • 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. [ Time Frame: Cycle ergometer testing will be done one hour after administration of sildenafil or matching placebo. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • That the decreased VO2 peak and decreased exercise performance from emissions inhalation will be the result of pulmonary hypertension causing decreased stroke volume. [ Time Frame: Pulmonary artery pressure will be measured before and immediately post exercise. ] [ Designated as safety issue: No ]
  • That plasma and urine sildenafil and metabolites will be measurable by liquid chromatography mass spectrometry (LC/MS) 6 h post ingestion. [ Time Frame: Blood and urine samples will be collected at 1, 3, 1nd 6 hours post exercise testing. ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: December 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Subjects will exercise in a high air pollutant environment after ingesting a standard dose of sildenafil.
Drug: sildenafil
sildenafil 50 mg ingested orally 1 hour prior to exercise testing
Other Name: Viagra
Active Comparator: 2
Subjects will exercise in a low pollutant environment after ingesting a standard dose of sildenafil.
Drug: sildenafil
sildenafil 50 mg ingested orally 1 hour prior to exercise testing
Other Name: Viagra
Placebo Comparator: 3
Subjects will exercise in a high pollutant environment after ingesting a placebo.
Other: placebo
matching placebo for sildenafil 50 mg to be ingested orally 1 hour prior to exercise testing.
Other Name: sugar pill
Placebo Comparator: 4
Subjects will exercise in a low pollutant environment after ingesting a placebo.
Other: placebo
matching placebo for sildenafil 50 mg to be ingested orally 1 hour prior to exercise testing.
Other Name: sugar pill

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00808912

Locations
United States, Pennsylvania
Marywood University
Scranton, Pennsylvania, United States, 18509
Sponsors and Collaborators
Marywood University
Investigators
Principal Investigator: Kenneth W Rundell, Ph.D. Marywood University
  More Information

No publications provided

Responsible Party: Kenneth W. Rundell Ph.D., Marywood University
ClinicalTrials.gov Identifier: NCT00808912     History of Changes
Other Study ID Numbers: MU2007-028
Study First Received: December 12, 2008
Last Updated: June 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Marywood University:
phosphodiesterase
sildenafil
pulmonary hypertension
exercise performance
air pollution

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
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 23, 2014