Does Sildenafil Increase Exercise Performance in Air Pollution?

Marywood University

Status: Completed

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

Treatments: Drug: sildenafil; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00808912

MU2007-028

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: Male

Ages: 18 to 30 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

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

Treatment:

Drug: sildenafil

2

Active Comparator group

Description:

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

Treatment:

Drug: sildenafil

3

Placebo Comparator group

Description:

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

Treatment:

Other: placebo

4

Placebo Comparator group

Description:

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

Treatment:

Other: placebo