On demand prostacyclin inhalation in obstructive pulmonary disease and pulmonary hypertensio
Completed
- Conditions
- Chronic obstructive pulmonary disease (COPD) with secondary pulmonary hypertensionOther chronic obstructive pulmonary diseaseRespiratory
- Registration Number
- ISRCTN61661881
- Lead Sponsor
- niversity Hospital Basel (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 17
Inclusion Criteria
1. Patients with diagnosed COPD (Global initiative for chronic Obstructive Lung Disease [GOLD] I - IV)
2. Confirmed disproportional pulmonary arterial hypertension (mean pulmonary artery pressure of over 45 mmHg during exercise and/or over 30 mmHg at rest)
3. Aged above 40 years, men and women
Exclusion Criteria
1. Mental disorder preventing appropriate judgment concerning study participation
2. Significant comorbidity resulting in reduced life expectancy (lower than 6 months)
3. Significant exacerbation of COPD within the last month
4. Decompensated heart failure (left ventricular ejection fraction below 30%)
5. Present pulmonary embolism
6. PH explained by another cause than COPD
7. Pregnant and breastfeeding women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Six-minute walking distance (6MWD) test, measured during the three study visits, after every inhalation.
- Secondary Outcome Measures
Name Time Method Measured during the three study visits, after every inhalation:<br>1. Oxygen consumption<br>2. Oxygen saturation<br>3. Ventilation<br>4. Carbon dioxide production<br>5. Arterial oxygen content<br>6. Alveolar-arterial gradient<br>7. BORG score