BOSSA Study: Bosentan for the treatment of Steroid-resistant Pulmonary Sarcoidosis
| ISRCTN | ISRCTN73579020 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73579020 |
| Secondary identifying numbers | N/A |
- Submission date
- 31/08/2010
- Registration date
- 27/09/2010
- Last edited
- 01/11/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Michael Tamm
Scientific
Scientific
University Hospital Basel
Petersgraben 4
Basel
4031
Switzerland
Study information
| Study design | Randomised placebo controlled phase II 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 contact details below to request a patient information sheet |
| Scientific title | Randomised placebo-controlled, double-blind, exploratory trial of Bosentan for Steroid-resistant Pulmonary Sarcoidosis: the BOSSA Study |
| Study acronym | BOSSA |
| Study hypothesis | To assess the safety and efficacy of a treatment with bosentan in steroid-resistant sarcoidosis. |
| Ethics approval(s) | The Ethics Committee of University Hospital Basel approved on the 29th May 2007 (ref: Nr. 71/07) |
| Condition | Sarcoidosis with pulmonary involvement |
| Intervention | Patients will be randomised to receive 1. Bosentan 2. Placebo 62.5 mg Twice daily (BID) for 4 weeks followed by 125 mg BID for 11 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Bosentan |
| Primary outcome measure | 1. Safety as measured by severe adverse events (SAEs) and necessity to stop bosentan due to increases liver enzymes 2. Efficacy at 12 months as measured by: 2.1. Overall response rate as defined by a 10% improvement of either TLC, DLCO, VO2 peak, endurance time at 75% of VO2 peak or 6-min walk distance (6MWD) or 2.2. A decrease in the HRCT-score greater than or equal to and absence of worsening by at least 10% in any functional parameters and absence of an increase in the HRCT-score greater than or equal to 2 |
| Secondary outcome measures | 1. Overall adverse events, reported during the regular visits of the patients at the centres 2. Changes in QoL, measured by SF-36 questionnaire 3. Decrease in expression of genes associated with firbroproliferation 4. Efficacy at 3, 6 and 9 months |
| Overall study start date | 01/10/2007 |
| Overall study end date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 36 |
| Participant inclusion criteria | 1. Biopsy-proven sarcoidosis with pulmonary involvement stages II, III, (IV) according to Silzbach 2. Persistant symptoms on long-term oral corticosteroids (greater than 2 months; 5 mg prednisone or equivalent and/or other immunosuppressive agents 3. Aged greater than 18 years 4. Informed written consent 5. Impaired exercise capacity (oxygen uptake [VO2] peak less than 80%) or resting lung functions (forced expiratory volume in one second [FEV1], forced vital capacity [FVC] or diffusing capacity of the lung for carbon monoxide [DLCO] less than 80%) |
| Participant exclusion criteria | 1. Systemic illness other than sarcoidosis requiring immunosuppressive therapy 2. Honey combing greater than 10% on High Resolution Computed Tomography [HRCT] scan 3. Marked disturbance of liver enzymes at baseline 4. Pregnancy 5. Relevant psychiatric illness or addictive disorder 6. Previous or current treatment with bosentan 7. Therapry with cyclosporine A |
| Recruitment start date | 01/10/2007 |
| Recruitment end date | 31/12/2012 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
University Hospital Basel
Basel
4031
Switzerland
4031
Switzerland
Sponsor information
University Hospital Basel (Switzerland)
Hospital/treatment centre
Hospital/treatment centre
c/o Prof. Michael Tamm
Petersgraben 4
Basel
4031
Switzerland
| Website | http://www.unispital-basel.ch/ |
|---|---|
"ROR" |
https://ror.org/04k51q396 |
Funders
Funder type
Industry
Actelion Pharma Schweiz AG (Germany)
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 | 28/10/2018 | Yes | No |
Editorial Notes
01/11/2018: Publication reference added.
