Pulmonary HypertensionNCT00808912
Does Sildenafil Increase Exercise Performance in Air Pollution?
A study testing sildenafil in people with Pulmonary Hypertension and Pulmonary Artery Pressure, run by Marywood University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension, Pulmonary Artery Pressure, Exercise Performance
- What is being tested?
- sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-asthmatic
- asthmatic
- active participants in endurance sports.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- sildenafil, placebo
- Keywords
- phosphodiesterase, sildenafil, pulmonary hypertension, exercise performance, air pollution
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sildenafilDrug
Also called Viagra
sildenafil 50 mg ingested orally 1 hour prior to exercise testing
placeboOther
Also called sugar pill
matching placebo for sildenafil 50 mg to be ingested orally 1 hour prior to exercise testing.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Subjects will exercise in a high air pollutant environment after ingesting a standard dose of sildenafil. Receives: Drug: sildenafil |
| 2 | Active comparator | Subjects will exercise in a low pollutant environment after ingesting a standard dose of sildenafil. Receives: Drug: sildenafil |
| 3 | Placebo comparator | Subjects will exercise in a high pollutant environment after ingesting a placebo. Receives: Other: placebo |
| 4 | Placebo comparator | Subjects will exercise in a low pollutant environment after ingesting a placebo. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Blood and urine samples will be collected at 1, 3, 1nd 6 hours post exercise testing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marywood University
- Sponsor type
- University, hospital or other
- Investigators
- Kenneth W Rundell, Ph.D., Principal investigator, Marywood University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808912
- Sponsor's protocol ID
- MU2007-028
- Status last verified
- Jun 2010
- First submitted
- 12 Dec 2008
- Last updated
- 23 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreased Pulmonary Artery Pressure by Oral Sildenafil Injection During Exercise in Air Pollution Increases Exercise Performance.
- ClinicalTrials.gov ID
- NCT00808912
- Acronym / sponsor ID
- MU2007-028
- Keywords
- phosphodiesterase, sildenafil, pulmonary hypertension, exercise performance, air pollution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Marywood UniversityUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 16 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: sildenafilSubjects will exercise in a high air pollutant environment after ingesting a standard dose of sildenafil. |
| 2 | Active comparator | Drug: sildenafilSubjects will exercise in a low pollutant environment after ingesting a standard dose of sildenafil. |
| 3 | Placebo comparator | Other: placeboSubjects will exercise in a high pollutant environment after ingesting a placebo. |
| 4 | Placebo comparator | Other: placeboSubjects will exercise in a low pollutant environment after ingesting a placebo. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- non-asthmatic
- asthmatic
- active participants in endurance sports.
Key exclusion criteria (6 listed)
- history of high blood pressure
- history of heart disease
- pulmonary arterial hypertension
- pulmonary emboli
- diagnosis of moderate to severe asthma (FEV1 <75% predicted)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sildenafilAlso: Viagrasildenafil 50 mg ingested orally 1 hour prior to exercise testing | Drug | 1, 2 |
| placeboAlso: sugar pillmatching placebo for sildenafil 50 mg to be ingested orally 1 hour prior to exercise testing. | Other | 3, 4 |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth W Rundell, Ph.D. principal investigator
Marywood University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sildenafil in people with Pulmonary Hypertension and Pulmonary Artery Pressure, run by Marywood University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2010.