On demand prostacyclin inhalation in obstructive pulmonary disease and pulmonary hypertension

ISRCTN ISRCTN61661881
DOI https://doi.org/10.1186/ISRCTN61661881
Protocol serial number 1.2
Sponsor University Hospital Basel (Switzerland)
Funder University Hospital Basel (Switzerland)
Submission date
06/10/2009
Registration date
11/11/2009
Last edited
25/02/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Daiana Stolz
Scientific

Petersgraben 4
Basel
4031
Switzerland

stolzd@uhbs.ch

Study information

Primary study designInterventional
Study designInvestigator driven single centre prospective randomised double-blind crossover study
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleOn demand prostacyclin inhalation in obstructive pulmonary disease and pulmonary hypertension: a single centre prospective randomised double-blind crossover study
Study acronymThe OPTION pilot study
Study objectivesWe hypothesise that inhalative iloprost improves the exercise capacity in chronic obstructive pulmonary disease (COPD) patients with secondary pulmonary hypertension (PH).
Ethics approval(s)Ethics Committee of Basel (Ethikkommission Beider Basel, Switzerland) approved on the 10th August 2009 (ref: EKBB 190/09)
Health condition(s) or problem(s) studiedChronic obstructive pulmonary disease (COPD) with secondary pulmonary hypertension
InterventionIn 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)
3. 20 μg iloprost diluted in 0.9% saline (2 ml)

All study visits have to be done on different days within one month.
Intervention typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Iloprost
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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

Completion date01/11/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration17
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/10/2009
Date of final enrolment01/11/2010

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Petersgraben 4
Basel
4031
Switzerland

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2012 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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