Condition category
Respiratory
Date applied
06/10/2009
Date assigned
11/11/2009
Last edited
25/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Daiana Stolz

ORCID ID

Contact details

Petersgraben 4
Basel
4031
Switzerland
stolzd@uhbs.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.2

Study information

Scientific title

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

Acronym

The OPTION pilot study

Study hypothesis

We hypothesise that inhalative iloprost improves the exercise capacity in chronic obstructive pulmonary disease (COPD) patients with secondary pulmonary hypertension (PH).

Ethics approval

Ethics Committee of Basel (Ethikkommission Beider Basel, Switzerland) approved on the 10th August 2009 (ref: EKBB 190/09)

Study design

Investigator driven single centre prospective randomised double-blind crossover study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Iloprost

Primary outcome measures

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 trial start date

01/10/2009

Overall trial end date

01/11/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

17

Participant 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

Recruitment start date

01/10/2009

Recruitment end date

01/11/2010

Locations

Countries of recruitment

Switzerland

Trial participating centre

Petersgraben 4
Basel
4031
Switzerland

Sponsor information

Organisation

University Hospital Basel (Switzerland)

Sponsor details

Petersgraben 4
Basel
4031
Switzerland

Sponsor type

Hospital/treatment centre

Website

http://www.unispital-basel.ch/

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Basel (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23300624

Publication citations

  1. Results

    Boeck L, Tamm M, Grendelmeier P, Stolz D, Acute effects of aerosolized iloprost in COPD related pulmonary hypertension - a randomized controlled crossover trial., PLoS ONE, 2012, 7, 12, e52248, doi: 10.1371/journal.pone.0052248.

Additional files

Editorial Notes