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Does Sildenafil Increase Exercise Performance in Air Pollution?

Primary Purpose

Pulmonary Hypertension, Pulmonary Artery Pressure, Exercise Performance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
sildenafil
placebo
Sponsored by
Marywood University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pulmonary Hypertension focused on measuring phosphodiesterase, sildenafil, pulmonary hypertension, exercise performance, air pollution

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Marywood University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Subjects will exercise in a high air pollutant environment after ingesting a standard dose of sildenafil.

Subjects will exercise in a low pollutant environment after ingesting a standard dose of sildenafil.

Subjects will exercise in a high pollutant environment after ingesting a placebo.

Subjects will exercise in a low pollutant environment after ingesting a placebo.

Outcomes

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.

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.
That plasma and urine sildenafil and metabolites will be measurable by liquid chromatography mass spectrometry (LC/MS) 6 h post ingestion.

Full Information

First Posted
December 12, 2008
Last Updated
June 22, 2010
Sponsor
Marywood University
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1. Study Identification

Unique Protocol Identification Number
NCT00808912
Brief Title
Does Sildenafil Increase Exercise Performance in Air Pollution?
Official Title
Decreased Pulmonary Artery Pressure by Oral Sildenafil Injection During Exercise in Air Pollution Increases Exercise Performance.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Marywood University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension, Pulmonary Artery Pressure, Exercise Performance, Air Pollution
Keywords
phosphodiesterase, sildenafil, pulmonary hypertension, exercise performance, air pollution

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Subjects will exercise in a high air pollutant environment after ingesting a standard dose of sildenafil.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Subjects will exercise in a low pollutant environment after ingesting a standard dose of sildenafil.
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Subjects will exercise in a high pollutant environment after ingesting a placebo.
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Subjects will exercise in a low pollutant environment after ingesting a placebo.
Intervention Type
Drug
Intervention Name(s)
sildenafil
Other Intervention Name(s)
Viagra
Intervention Description
sildenafil 50 mg ingested orally 1 hour prior to exercise testing
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
sugar pill
Intervention Description
matching placebo for sildenafil 50 mg to be ingested orally 1 hour prior to exercise testing.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
Title
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth W Rundell, Ph.D.
Organizational Affiliation
Marywood University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marywood University
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18509
Country
United States

12. IPD Sharing Statement

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Does Sildenafil Increase Exercise Performance in Air Pollution?

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