Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis
2 other identifiers
interventional
132
0 countries
N/A
Brief Summary
Clinical and experimental studies suggest that bosentan could delay the progression of interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a condition for which no established efficacious treatment is available. The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO Class III and IV, to a new category of patients suffering from ILD associated with SSc.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2003
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 6, 2003
CompletedFirst Posted
Study publicly available on registry
October 8, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFebruary 3, 2025
January 1, 2025
2.2 years
October 6, 2003
January 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline to End-of-Study in 6-minute walk distance.
Secondary Outcomes (2)
Time to death (all causes) or to worsening of PFTs up to End-of-Study.
Worsening of PFTs (on 2 consecutive tests at least 4 weeks apart) is defined as: decrease from baseline ≥ 10% in FVC OR decrease from baseline ≥ 15% in DLco AND ≥ 6% in FVC
Interventions
Eligibility Criteria
You may qualify if:
- Systemic Sclerosis diffuse or limited
- Significant Interstitial Lung Disease on HRCTscan
- DLco \< 80% predicted
- Dyspnea on exertion
- Walk not limited by musculoskeletal reasons
You may not qualify if:
- Interstitial Lung Disease due to other conditions than SSc
- End stage restrictive or obstructive lung disease
- Severe cardiac or renal diseases
- Significant pulmonary arterial hypertension
- Smoker (\> 5cig./day)
- Treatment with immunosuppressive, antifibrotic drugs, high dose corticosteroids (within 4 weeks of randomization)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Actelionlead
Related Publications (2)
Liu C, Chen J, Gao Y, Deng B, Liu K. Endothelin receptor antagonists for pulmonary arterial hypertension. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD004434. doi: 10.1002/14651858.CD004434.pub6.
PMID: 33765691DERIVEDSeibold JR, Denton CP, Furst DE, Guillevin L, Rubin LJ, Wells A, Matucci Cerinic M, Riemekasten G, Emery P, Chadha-Boreham H, Charef P, Roux S, Black CM. Randomized, prospective, placebo-controlled trial of bosentan in interstitial lung disease secondary to systemic sclerosis. Arthritis Rheum. 2010 Jul;62(7):2101-8. doi: 10.1002/art.27466.
PMID: 20506355DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 6, 2003
First Posted
October 8, 2003
Study Start
July 1, 2003
Primary Completion
September 1, 2005
Study Completion
September 1, 2005
Last Updated
February 3, 2025
Record last verified: 2025-01