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- Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or emphysema
- FEV1/FVC ratio < 70%
- FEV1 < 80%
- Stable medication regimen
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Sildenafil for Chronic Obstructive Pulmonary Disease | |||
Official Title ICMJE | A Double-blind, Placebo-controlled, Crossover Study of Sildenafil in Patients With Chronic Obstructive Pulmonary Disease | |||
Brief 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. | |||
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 Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 10 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | November 2008 | |||
Actual Primary Completion Date | November 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00104637 | |||
Other Study ID Numbers ICMJE | 1022 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Kawut, Steven, MD | |||
Study Sponsor ICMJE | Kawut, Steven, MD | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Kawut, Steven, MD | |||
Verification Date | May 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |