Condition category
Haematological Disorders
Date applied
31/08/2010
Date assigned
27/09/2010
Last edited
27/09/2010
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

Prof Michael Tamm

ORCID ID

Contact details

University Hospital Basel
Petersgraben 4
Basel
4031
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised placebo-controlled, double-blind, exploratory trial of Bosentan for Steroid-resistant Pulmonary Sarcoidosis: the BOSSA Study

Acronym

BOSSA

Study hypothesis

To assess the safety and efficacy of a treatment with bosentan in steroid-resistant sarcoidosis.

Ethics approval

The Ethics Committee of University Hospital Basel approved on the 29th May 2007 (ref: Nr. 71/07)

Study design

Randomised placebo controlled phase II 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 contact details below to request a patient information sheet

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

Phase

Phase II

Drug names

Bosentan

Primary outcome measures

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 trial start date

01/10/2007

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

36

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

Trial participating centre

University Hospital Basel
Basel
4031
Switzerland

Sponsor information

Organisation

University Hospital Basel (Switzerland)

Sponsor details

c/o Prof. Michael Tamm
Petersgraben 4
Basel
4031
Switzerland

Sponsor type

Hospital/treatment centre

Website

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

Funders

Funder type

Industry

Funder name

Actelion Pharma Schweiz AG (Germany)

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

Publication citations

Additional files

Editorial Notes