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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
History of Changes

December 12, 2008
June 22, 2010
December 2008
February 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00808912 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Does Sildenafil Increase Exercise Performance in Air Pollution?
Decreased Pulmonary Artery Pressure by Oral Sildenafil Injection During Exercise in Air Pollution Increases Exercise Performance.

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
  • Pulmonary Hypertension
  • Pulmonary Artery Pressure
  • Exercise Performance
  • Air Pollution
  • Drug: sildenafil
    sildenafil 50 mg ingested orally 1 hour prior to exercise testing
    Other Name: Viagra
  • Other: placebo
    matching placebo for sildenafil 50 mg to be ingested orally 1 hour prior to exercise testing.
    Other Name: sugar pill
  • Active Comparator: 1
    Subjects will exercise in a high air pollutant environment after ingesting a standard dose of sildenafil.
    Intervention: Drug: sildenafil
  • Active Comparator: 2
    Subjects will exercise in a low pollutant environment after ingesting a standard dose of sildenafil.
    Intervention: Drug: sildenafil
  • Placebo Comparator: 3
    Subjects will exercise in a high pollutant environment after ingesting a placebo.
    Intervention: Other: placebo
  • Placebo Comparator: 4
    Subjects will exercise in a low pollutant environment after ingesting a placebo.
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00808912
MU2007-028
No
Kenneth W. Rundell Ph.D., Marywood University
Marywood University
Not Provided
Principal Investigator: Kenneth W Rundell, Ph.D. Marywood University
Marywood University
June 2010

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