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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to determine if sildenafil improves the exercise capacity and lung function of patients with chronic obstructive pulmonary disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sildenafil / Placebo | Active Comparator | Sildenafil first, followed by washout, followed by placebo |
|
| Placebo / Sildenafil | Placebo Comparator | Placebo first, followed by washout, followed by Sildenafil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sildenafil citrate | Drug | sildenafil citrate 25 mg by mouth thrice daily (po tid) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6 Minute Walk Distance | The distance a subject walked within 6 minutes was measured and documented. | 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. | Period 1 and Period 3 ( within 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Function FVC (Forced Vital Capacity) | Data to calculate results for FVC was based on Period 1. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven M Kawut, M.D., M.S. | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia Univeristy, College of Physicians and Surgeons | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22360383 | Derived | 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. |
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The recruitment period began in February 2005 and ended by November 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sildenafil /Placebo | 25 mg sildenafil is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg placebo by mouth 3 times daily for 14 days. |
| FG001 | Placebo /Sildenafil | 25 mg placebo is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg sildenafil by mouth 3 times daily for 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: ( TREATMENT: 4 Weeks) |
|
| ||||||||||||||||||
| Period 2 (WASHOUT: 1 Week) |
| |||||||||||||||||||
| Period 3 ( TREATMENT: 4 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomized Participants | All enrolled and randomized participants who were administered 25 mg Sildenafil and 25mg placebo at 2 different time periods. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Pulmonary Function FVC (Forced Vital Capacity) | Data to calculate results for FVC was based on Period 1. | Posted | Least Squares Mean | 95% Confidence Interval | liters | Period 1 (4 weeks) |
|
|
9 weeks
Adverse events were monitored during the clinical trial period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sildenafil | 25 mg sildenafil is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg placebo by mouth 3 times daily for 14 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
The study had slow enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David J. Lederer, MD | Columbia University | 212-305-7771 | dl427@columbia.edu |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Placebo | Drug | 25 mg po tid |
|
| 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. | 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. | 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. | 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. | 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. | Period 1 and Period 3 ( within 8 weeks) |
| Oxygen Pulse | Oxygen pulse during Cardiopulmonary exercise test at peak exercise. | Period 1 and Period 3 ( within 8 weeks) |
| O2 Saturation at Peak Exercise | O2 Saturation at Peak Exercise measured during the Cardiopulmonary exercise test. | Period 1 and Period 3 ( within 8 weeks) |
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| NOT COMPLETED |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 6 Minute Walk Distance | The distance a subject walked within 6 minutes was measured and documented. | Posted | Least Squares Mean | 95% Confidence Interval | meters | Period 1 and Period 3 ( within 8 weeks) |
|
|
|
| Primary | VO2 Peak (Oxygen Consumption at Peak Exercise) | Oxygen consumption at peak exercise was measured at scheduled timepoints during treatment periods 1 and 3. | Posted | Least Squares Mean | 95% Confidence Interval | ml/kg/min | Period 1 and Period 3 ( within 8 weeks) |
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | liters | Period 1 ( 4 weeks) |
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | Period 1 and Period 3 ( within 8 weeks) |
|
|
|
| Secondary | Diffusing Capacity of Carbon Monoxide (DLCO) | Carbon Monoxide Diffusing Capacity was measured on the same days as the pulmonary function tests. | Posted | Least Squares Mean | 95% Confidence Interval | ml/min/torr | Period 1 and Period 3 ( within 8 weeks) |
|
|
|
| Secondary | Partial Pressure of Carbon Dioxide (PCO2) in Arterial Blood Gas (ABG) | Partial pressure of carbon dioxide in ABG performed breathing room air at rest. | Posted | Least Squares Mean | 95% Confidence Interval | mm Hg | Period 1 and Period 3 ( within 8 weeks) |
|
|
|
| Secondary | Partial Pressure of Oxygen (PO2) in Arterial Blood Gas (ABG) | Partial Pressure of Oxygen in ABG breathing room air at rest. | Posted | Least Squares Mean | 95% Confidence Interval | mm Hg | Period 1 and Period 3 ( within 8 weeks) |
|
|
|
| Secondary | A-a Gradient (Alveolar-arterial Gradient) | A-a gradient was measured with ABG breathing room air at rest. | Posted | Least Squares Mean | 95% Confidence Interval | mm Hg | Period 1 and Period 3 ( within 8 weeks) |
|
|
|
| Secondary | Oxygen Pulse | Oxygen pulse during Cardiopulmonary exercise test at peak exercise. | Posted | Least Squares Mean | 95% Confidence Interval | ml/beat | Period 1 and Period 3 ( within 8 weeks) |
|
|
|
| Secondary | O2 Saturation at Peak Exercise | O2 Saturation at Peak Exercise measured during the Cardiopulmonary exercise test. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of oxygen saturation | Period 1 and Period 3 ( within 8 weeks) |
|
|
|
| 0 |
| 10 |
| 9 |
| 10 |
| EG001 | Placebo | 25 mg placebo is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg sildenafil by mouth 3 times daily for 14 days. | 0 | 9 | 1 | 9 |
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Blurry vision | Eye disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Pleuritic pain | General disorders | Systematic Assessment |
|
| Nasal Congestion | General disorders | Systematic Assessment |
|
| Upper respirartory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Epistaxis | General disorders | Systematic Assessment |
|
| Rib Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Facial Flushing | General disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |