BOSSA Study: Bosentan for the treatment of Steroid-resistant Pulmonary Sarcoidosis

ISRCTN	ISRCTN73579020
DOI	https://doi.org/10.1186/ISRCTN73579020
Protocol serial number	N/A
Sponsor	University Hospital Basel (Switzerland)
Funder	Actelion Pharma Schweiz AG (Germany)

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 of protocol

Not provided at time of registration

Contact information

Prof Michael Tamm
Scientific

University Hospital Basel
Petersgraben 4
Basel
4031
Switzerland

Study information

Primary study design	Interventional
Study design	Randomised placebo controlled phase II study
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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)
Health condition(s) or problem(s) studied	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
Phase	Phase II
Drug / device / biological / vaccine name(s)	Bosentan
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	36
Key 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%)
Key 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
Date of first enrolment	01/10/2007
Date of final enrolment	31/12/2012

Locations

Countries of recruitment

Switzerland

Study participating centre

University Hospital Basel

Basel
4031
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

01/11/2018: Publication reference added.