Pulmonary Disease, Chronic ObstructivePhase 2NCT00104637
Sildenafil for Chronic Obstructive Pulmonary Disease
A Phase 2 study testing sildenafil citrate in people with Pulmonary Disease, Chronic Obstructive and Emphysema, run by Kawut, Steven, MD at 1 site in United States.
Trial summary
The purpose of this study is to determine if sildenafil improves the exercise capacity and lung function of patients with chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Emphysema
- What is being tested?
- sildenafil citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Nov 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or emphysema
- FEV1/FVC ratio < 70%
- FEV1 < 80%
- Stable medication regimen
Who cannot join
- COPD exacerbation or hospitalization in the past 3 months
- Heart disease
- Contraindication to sildenafil
- Unrelated lung disease
- Inability to walk or pedal on a stationary bike
- Pregnancy or breast-feeding
- Pulmonary hypertension at rest
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia Univeristy, College of Physicians and Surgeons
New York, New York, 10032
About this study
Official title: A Double-blind, Placebo-controlled, Crossover Study of Sildenafil in Patients With Chronic Obstructive Pulmonary Disease
The purpose of this study is to determine if sildenafil improves the exercise capacity and lung function of patients with chronic obstructive pulmonary disease.
Read the detailed description
Patients with chronic obstructive pulmonary disease (COPD) suffer from impaired exercise capacity and quality-of-life, largely related to shortness of breath. Many of the therapies currently available for COPD are aimed at improving these factors. Exercise capacity is limited in part by high blood pressure in the blood vessels in the lungs. Sildenafil, also known as Viagra, is an FDA-approved therapy for male erectile dysfunction. One of its effects is to relax (or open) the lung vessels, thereby lowering the blood pressure in the lungs. We hypothesize that sildenafil will result in an improvement in exercise capacity, quality-of-life, and shortness of breath.
Enrolled subjects will receive sildenafil or placebo for 4 weeks followed by exercise tests, breathing tests, and administration of quality-of-life questionnaires. Subjects will then receive placebo or sildenafil (whichever one they did not receive for the first 4 weeks) for another 4 weeks, followed by the same testing.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Emphysema
- Being tested
- sildenafil citrate, Placebo
- Keywords
- Chronic Obstructive Pulmonary Disease, Emphysema, Phosphodiesterase inhibitors, Sildenafil, Exercise testing, Quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sildenafil citrateDrug
sildenafil citrate 25 mg by mouth thrice daily (po tid)
PlaceboDrug
25 mg po tid
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil / Placebo | Active comparator | Sildenafil first, followed by washout, followed by placebo Receives: Drug: sildenafil citrate; Drug: Placebo |
| Placebo / Sildenafil | Placebo comparator | Placebo first, followed by washout, followed by Sildenafil Receives: Drug: sildenafil citrate; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Distance
The distance a subject walked within 6 minutes was measured and documented.
Measured: Period 1 and Period 3 ( within 8 weeks)
VO2 Peak (Oxygen Consumption at Peak Exercise)
Oxygen consumption at peak exercise was measured at scheduled timepoints during treatment periods 1 and 3.
Measured: Period 1 and Period 3 ( within 8 weeks)
Secondary outcomes (9)
Pulmonary Function FVC (Forced Vital Capacity)
Data to calculate results for FVC was based on Period 1.
Measured: Period 1 (4 weeks)
Forced Expiratory Volume in the First Second (FEV1 )
The volume of air exhaled in the first second. Data to calculate results for FEV1 was based on Period 1 only.
Measured: Period 1 ( 4 weeks)
Borg Dyspnea(Scale That Measures Breathlessness) Score at Finish of 6 Minute Walk Test (6MWT)
Participants were asked to scale the breathlessness felt at the end of 6MWT from 0 to 10, with 0 being the least discomfort and 10 being the most discomfort in breathing.
Measured: Period 1 and Period 3 ( within 8 weeks)
Diffusing Capacity of Carbon Monoxide (DLCO)
Carbon Monoxide Diffusing Capacity was measured on the same days as the pulmonary function tests.
Measured: Period 1 and Period 3 ( within 8 weeks)
Partial Pressure of Carbon Dioxide (PCO2) in Arterial Blood Gas (ABG)
Partial pressure of carbon dioxide in ABG performed breathing room air at rest.
Measured: Period 1 and Period 3 ( within 8 weeks)
Partial Pressure of Oxygen (PO2) in Arterial Blood Gas (ABG)
Partial Pressure of Oxygen in ABG breathing room air at rest.
Measured: Period 1 and Period 3 ( within 8 weeks)
A-a Gradient (Alveolar-arterial Gradient)
A-a gradient was measured with ABG breathing room air at rest.
Measured: Period 1 and Period 3 ( within 8 weeks)
Oxygen Pulse
Oxygen pulse during Cardiopulmonary exercise test at peak exercise.
Measured: Period 1 and Period 3 ( within 8 weeks)
O2 Saturation at Peak Exercise
O2 Saturation at Peak Exercise measured during the Cardiopulmonary exercise test.
Measured: Period 1 and Period 3 ( within 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2005 (estimated)
- Study startFeb 2005
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kawut, Steven, MD
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Steven M Kawut, M.D., M.S., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104637
- Sponsor's protocol ID
- 1022
- Status last verified
- May 2012
- First submitted
- 3 Mar 2005
- Last updated
- 21 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lederer DJ, Bartels MN, Schluger NW, Brogan F, Jellen P, Thomashow BM, Kawut SM. Sildenafil for chronic obstructive pulmonary disease: a randomized crossover trial. COPD. 2012 Jun;9(3):268-75. doi: 10.3109/15412555.2011.651180. Epub 2012 Feb 23.
PubMed 22360383
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Crossover Study of Sildenafil in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00104637
- Acronym / sponsor ID
- 1022
- Conditions
- Pulmonary Disease, Chronic Obstructive, Emphysema
- Keywords
- Chronic Obstructive Pulmonary Disease, Emphysema, Phosphodiesterase inhibitors, Sildenafil, Exercise testing, Quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kawut, Steven, MD
- Collaborators
- Pfizer
- Study start
- Feb 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 4 Mar 2005 (estimated)
- Results
- Posted 21 May 2012
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 determine if sildenafil improves the exercise capacity and lung function of patients with chronic obstructive pulmonary disease.
Detailed description
Patients with chronic obstructive pulmonary disease (COPD) suffer from impaired exercise capacity and quality-of-life, largely related to shortness of breath. Many of the therapies currently available for COPD are aimed at improving these factors. Exercise capacity is limited in part by high blood pressure in the blood vessels in the lungs. Sildenafil, also known as Viagra, is an FDA-approved therapy for male erectile dysfunction. One of its effects is to relax (or open) the lung vessels, thereby lowering the blood pressure in the lungs. We hypothesize that sildenafil will result in an improvement in exercise capacity, quality-of-life, and shortness of breath.
Enrolled subjects will receive sildenafil or placebo for 4 weeks followed by exercise tests, breathing tests, and administration of quality-of-life questionnaires. Subjects will then receive placebo or sildenafil (whichever one they did not receive for the first 4 weeks) for another 4 weeks, followed by the same testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sildenafil / Placebo | Active comparator | Drug: sildenafil citrate, Drug: PlaceboSildenafil first, followed by washout, followed by placebo |
| Placebo / Sildenafil | Placebo comparator | Drug: sildenafil citrate, Drug: PlaceboPlacebo first, followed by washout, followed by Sildenafil |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or emphysema
- FEV1/FVC ratio < 70%
- FEV1 < 80%
- Stable medication regimen
Key exclusion criteria (7 listed)
- COPD exacerbation or hospitalization in the past 3 months
- Heart disease
- Contraindication to sildenafil
- Unrelated lung disease
- Inability to walk or pedal on a stationary bike
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 |
|---|---|---|
| sildenafil citratesildenafil citrate 25 mg by mouth thrice daily (po tid) | Drug | Placebo / Sildenafil, Sildenafil / Placebo |
| Placebo25 mg po tid | Drug | Placebo / Sildenafil, Sildenafil / Placebo |
Primary outcome
6 Minute Walk Distance
Time frame: Period 1 and Period 3 ( within 8 weeks)
The distance a subject walked within 6 minutes was measured and documented.
VO2 Peak (Oxygen Consumption at Peak Exercise)
Time frame: Period 1 and Period 3 ( within 8 weeks)
Oxygen consumption at peak exercise was measured at scheduled timepoints during treatment periods 1 and 3.
9 secondary outcomes
Pulmonary Function FVC (Forced Vital Capacity)
Time frame: Period 1 (4 weeks)
Forced Expiratory Volume in the First Second (FEV1 )
Time frame: Period 1 ( 4 weeks)
Borg Dyspnea(Scale That Measures Breathlessness) Score at Finish of 6 Minute Walk Test (6MWT)
Time frame: Period 1 and Period 3 ( within 8 weeks)
Diffusing Capacity of Carbon Monoxide (DLCO)
Time frame: Period 1 and Period 3 ( within 8 weeks)
Partial Pressure of Carbon Dioxide (PCO2) in Arterial Blood Gas (ABG)
Time frame: Period 1 and Period 3 ( within 8 weeks)
Partial Pressure of Oxygen (PO2) in Arterial Blood Gas (ABG)
Time frame: Period 1 and Period 3 ( within 8 weeks)
A-a Gradient (Alveolar-arterial Gradient)
Time frame: Period 1 and Period 3 ( within 8 weeks)
Oxygen Pulse
Time frame: Period 1 and Period 3 ( within 8 weeks)
O2 Saturation at Peak Exercise
Time frame: Period 1 and Period 3 ( within 8 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22360383Lederer DJ, Bartels MN, Schluger NW, Brogan F, Jellen P, Thomashow BM, Kawut SM. Sildenafil for chronic obstructive pulmonary disease: a randomized crossover trial. COPD. 2012 Jun;9(3):268-75. doi: 10.3109/15412555.2011.651180. Epub 2012 Feb 23.
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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.
Steven M Kawut, M.D., M.S. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sildenafil citrate in people with Pulmonary Disease, Chronic Obstructive and Emphysema, run by Kawut, Steven, MD 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 4 inclusion and 7 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 21 May 2012. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
6 Minute Walk Distance (time frame: Period 1 and Period 3 ( within 8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00104637, which also lists 1 linked publication.
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 21 May 2012.