NCT00071461: BUILD 1

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Idiopathic Pulmonary Fibrosis, Open Label Extension

Completed Phase 2/Phase 3 Last updated 22 February 2012

What this trial tests

Phase 2/Phase 3 trial testing bosentan in Idiopathic Pulmonary Fibrosis in 158 participants. Completed in 1 May 2010.

Timeline

1 August 2003

Primary endpoint
1 September 2005

1 May 2010

Quick facts

Lead sponsor	Actelion
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	158
Start date	1 August 2003
Primary completion	1 September 2005
Estimated completion	1 May 2010
Sites	29 locations across United States, Canada, France, Germany, Israel, Italy, Switzerland, United Kingdom

Drugs / interventions tested

• bosentan (BOSENTAN) — full drug profile →
• Placebo

Conditions studied

• Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →

Sponsor

Actelion — full company profile →

Who can join

18 and older, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in 6-minute walk distance
  Time frame: Baseline to End-of-Period 1

Sponsor's own description

Endothelin-1 (ET-1) is expressed in a variety of pulmonary pathological conditions including pulmonary vascular disease and pulmonary fibrosis.

Bosentan (an oral dual ET-1 receptor antagonist) could delay the progression of idiopathic pulmonary fibrosis (IPF), a condition for which no established treatment is available.

The present trial investigates a possible use of 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 IPF.

It was decided to offer Open Label treatment (bosentan) for patients willing to continue in the BUILD 1 study.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. New therapeutic targets in idiopathic pulmonary fibrosis. Aiming to rein in runaway wound-healing responses.
   Ahluwalia N, Shea BS, Tager AM. · · 2014 · cited 186× · PMID 25090037 · DOI 10.1164/rccm.201403-0509pp
2. A review of current and novel therapies for idiopathic pulmonary fibrosis.
   Rafii R, Juarez MM, Albertson TE, Chan AL. · · 2013 · cited 102× · PMID 23372951 · DOI 10.3978/j.issn.2072-1439.2012.12.07
3. Endothelin Receptor Antagonists: Status Quo and Future Perspectives for Targeted Therapy.
   Enevoldsen FC, Sahana J, Wehland M, Grimm D, et al · · 2020 · cited 88× · PMID 32197449 · DOI 10.3390/jcm9030824
4. Development of antifibrotic therapy for stricturing Crohn's disease: lessons from randomized trials in other fibrotic diseases.
   Lin SN, Mao R, Qian C, Bettenworth D, et al · · 2022 · cited 62× · PMID 34569264 · DOI 10.1152/physrev.00005.2021
5. Smoking and idiopathic pulmonary fibrosis.
   Oh CK, Murray LA, Molfino NA. · · 2012 · cited 60× · PMID 22448328 · DOI 10.1155/2012/808260
6. Targeting GPCR Signaling for Idiopathic Pulmonary Fibrosis Therapies.
   Haak AJ, Ducharme MT, Diaz Espinosa AM, Tschumperlin DJ. · · 2020 · cited 56× · PMID 32008852 · DOI 10.1016/j.tips.2019.12.008
7. Targeting Alveolar Repair in Idiopathic Pulmonary Fibrosis.
   Ptasinski VA, Stegmayr J, Belvisi MG, Wagner DE, et al · · 2021 · cited 43× · PMID 34129811 · DOI 10.1165/rcmb.2020-0476tr
8. The 6-min walk test as a primary end-point in interstitial lung disease.
   Harari S, Wells AU, Wuyts WA, Nathan SD, et al · · 2022 · cited 35× · PMID 36002171 · DOI 10.1183/16000617.0087-2022