Treatment of Idiopathic Pulmonary Fibrosis with Long Acting Octreotide

Phase 1

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: octreotide

• Registration Number: NCT00463983
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2007-04-18
• Study First Submitted QC: 2007-04-18
• Study First Posted: 2007-04-20
• Primary Completion: 2010-01
• Study Completion: 2012-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
octreotide	octreotide	octreotide SR 30 mg intra muscularly every 4 weeks

Primary Outcome Measures

Name	Time	Method
FVC changes	12 months

Secondary Outcome Measures

Name	Time	Method
DLCO changes	12 months

Trial Locations

Locations (16)

Service de Pneumologie Hôpital Avicenne 125 rue de Stalingrad; 🇫🇷 Bobigny Cedex, France

Service de Pneumologie Hôpital Ambroise Paré; 🇫🇷 Boulogne-Billancourt, France

Service de Pneumologie Hôpital Côte de Nacre; 🇫🇷 Caen, France

Service de Pneumologie Hôpital Antoine Béclère; 🇫🇷 Clamart, France

Service de Pneumologie Centre hospitalier intercommunal de Créteil; 🇫🇷 Creteil, France

Service de Pneumologie Hôpital Albert calmette; 🇫🇷 Lille Cedex, France

Service de Pneumologie Hôpital Sainte Marguerite BP 29; 🇫🇷 Marseille Cedex 09, France

Service de Pneumologie Hôpital Saint Louis 1 avenue Claude-Vellefaux; 🇫🇷 Paris Cedex 10, France

Service de Pneumologie Hôpital de la Pitié-Salpetrière 47-83 boulevard de l'hôpital; 🇫🇷 Paris Cedex 13, France

Service de Pneumologie Hôpital Cochin; 🇫🇷 Paris Cedex 14, France

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