Treatment of Idiopathic Pulmonary Fibrosis with Long Acting Octreotide (FIBROSAND)

Institut National de la Santé Et de la Recherche Médicale, France

Status and phase: Completed; Phase 2; Phase 1

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: octreotide

Study type: Interventional

Funder types: Other

Identifiers

NCT00463983

C05-32

Details and patient eligibility

About

Octreotide is a somatostatin analog with a long half-life in vivo. Octreotide has interesting anti-inflammatory and anti-fibrotic properties in vitro and in vivo. Somatostatin receptors are increased and Octreotide uptake is increased in the lung in patients with idiopathic pulmonary fibrosis. Our hypothesis is that octreotide may slow the degradation of lung function in patients with IPF. In this proof of concept study, patients with IPF will receive an intramuscular injection of slow release octreotide (Sandostatin LP, 30 mg)every 4 weeks for 48 weeks. Lung function (FVC, DLCO), HRCT scores for fibrosis and ground glass, 6 minute walking test,quality of life and survival will be monitored.

Enrollment: 25 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• confident diagnosis of IPF according to ATS/ERS criteria

Exclusion criteria

• known intolerance to somatostatin or octreotide
• another disease with predicted survival < 12 months
• pregnancy or lactation
• previous treatment with somatostatin or somatostatin analogs
• patient on a waiting list for transplantation
• antifibrotic treatment or prednisone > 10 mg/day within the last 6 weeks
• symptomatic biliary lithiasis
• blood coagulation disorders that prevent intra-muscular injections
• HIV infection
• hepatitis B or C active infection

Trial design

25 participants in 1 patient group

octreotide

Experimental group

Description:

octreotide SR 30 mg intra muscularly every 4 weeks

Treatment:

Drug: octreotide