On demand prostacyclin inhalation in obstructive pulmonary disease and pulmonary hypertension
| ISRCTN | ISRCTN61661881 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61661881 |
| Secondary identifying numbers | 1.2 |
- 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
Scientific
Petersgraben 4
Basel
4031
Switzerland
| stolzd@uhbs.ch |
Study information
| Study design | Investigator driven single centre prospective randomised double-blind crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | On demand prostacyclin inhalation in obstructive pulmonary disease and pulmonary hypertension: a single centre prospective randomised double-blind crossover study |
| Study acronym | The OPTION pilot study |
| Study objectives | We 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) studied | Chronic obstructive pulmonary disease (COPD) with secondary pulmonary hypertension |
| Intervention | 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) 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 type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Iloprost |
| Primary outcome measure | Six-minute walking distance (6MWD) test, measured during the three study visits, after every inhalation. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/10/2009 |
| Completion date | 01/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target number of participants | 17 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2009 |
| Date of final enrolment | 01/11/2010 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Petersgraben 4
Basel
4031
Switzerland
4031
Switzerland
Sponsor information
University Hospital Basel (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
Petersgraben 4
Basel
4031
Switzerland
| Website | http://www.unispital-basel.ch/ |
|---|---|
"ROR" |
https://ror.org/04k51q396 |
Funders
Funder type
Hospital/treatment centre
University Hospital Basel (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
