Phase 2
N=10
Sildenafil for Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive · Emphysema
Bottom Line
View on ClinicalTrials.gov: NCT00104637 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: 6 Minute Walk Distance — 458.2; 466.1 meters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- sildenafil citrate (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Kawut, Steven, MD
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6 Minute Walk Distance |
458.2; 466.1 | — |
| PRIMARY VO2 Peak (Oxygen Consumption at Peak Exercise) |
13.7; 13.8 | — |
| SECONDARY Pulmonary Function FVC (Forced Vital Capacity) |
2.8; 2.8 | — |
| SECONDARY Forced Expiratory Volume in the First Second (FEV1 ) |
1.1; 1.1 | — |
| SECONDARY Borg Dyspnea(Scale That Measures Breathlessness) Score at Finish of 6 Minute Walk Test (6MWT) |
3.9; 3.8 | — |
| SECONDARY Diffusing Capacity of Carbon Monoxide (DLCO) |
11; 11 | — |
| SECONDARY Partial Pressure of Carbon Dioxide (PCO2) in Arterial Blood Gas (ABG) |
42; 40 | — |
| SECONDARY Partial Pressure of Oxygen (PO2) in Arterial Blood Gas (ABG) |
73; 77 | — |
| SECONDARY A-a Gradient (Alveolar-arterial Gradient) |
25; 23 | — |
| SECONDARY Oxygen Pulse |
8.7; 9.5 | — |
| SECONDARY O2 Saturation at Peak Exercise |
95; 96 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or emphysema
- FEV1/FVC ratio < 70%
- FEV1 < 80%
- Stable medication regimen
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00104637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.