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On demand prostacyclin inhalation in obstructive pulmonary disease and pulmonary hypertension

On demand prostacyclin inhalation in obstructive pulmonary disease and pulmonary hypertension: a single centre prospective randomised double-blind crossover study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN61661881
Enrollment
17
Registered
2009-11-11
Start date
2009-10-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease (COPD) with secondary pulmonary hypertension Respiratory Other chronic obstructive pulmonary disease

Interventions

In every of the three study visits the patient will inhale one of the following in a randomised manner prior to the exercise test: 1. 0.9% saline (2 ml) 2. 10 µg iloprost diluted in 0.9% saline (2 ml

Sponsors

University Hospital Basel (Switzerland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Six-minute walking distance (6MWD) test, measured during the three study visits, after every inhalation.

Secondary

MeasureTime frame
Measured during the three study visits, after every inhalation: 1. Oxygen consumption 2. Oxygen saturation 3. Ventilation 4. Carbon dioxide production 5. Arterial oxygen content 6. Alveolar-arterial gradient 7. BORG score

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 24, 2026