Does Sildenafil Increase Exercise Performance in Air Pollution?

NCT00808912 | Completed

• 1 other identifier: MU2007-028
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension; Pulmonary Artery Pressure; Exercise Performance; Air Pollution

Keywords

phosphodiesterase; sildenafil; pulmonary hypertension; exercise performance; air pollution

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• 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.

• 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.

Study Arms (4)

1

ACTIVE COMPARATOR

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

Drug: sildenafil

2

ACTIVE COMPARATOR

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

Drug: sildenafil

3

PLACEBO COMPARATOR

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

Other: placebo

4

PLACEBO COMPARATOR

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

Other: placebo

Interventions

sildenafil DRUG

sildenafil 50 mg ingested orally 1 hour prior to exercise testing

Also known as: Viagra

1; 2

placebo OTHER

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

Also known as: sugar pill

3; 4

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• non-asthmatic
• asthmatic
• active participants in endurance sports.

You may not qualify if:

• 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

Sponsors & Collaborators

• Marywood University: lead

Study Sites (1)

Marywood University

Scranton, Pennsylvania, 18509, United States

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Sildenafil Citrate; Sugars

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

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; Carbohydrates

Study Officials

• Kenneth W Rundell, Ph.D.

  Marywood University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 12, 2008
• First Posted: December 16, 2008
• Study Start: December 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: June 23, 2010

Record last verified: 2010-06

Locations

US (1)