Treatment of Idiopathic Pulmonary Fibrosis With Long Acting Octreotide

Overview

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.

Full Title of Study: “Phase 2 Study of Long Acting Octreotide in Idiopathic Pulmonary Fibrosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2010

Interventions

  • Drug: octreotide

Arms, Groups and Cohorts

  • Experimental: octreotide
    • octreotide SR 30 mg intra muscularly every 4 weeks

Clinical Trial Outcome Measures

Primary Measures

  • FVC changes
    • Time Frame: 12 months

Secondary Measures

  • DLCO changes
    • Time Frame: 12 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institut National de la Santé Et de la Recherche Médicale, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bruno Crestani, MD, PhD, Principal Investigator, INSERM, France

References

Lebtahi R, Moreau S, Marchand-Adam S, Debray MP, Brauner M, Soler P, Marchal J, Raguin O, Gruaz-Guyon A, Reubi JC, Le Guludec D, Crestani B. Increased uptake of 111In-octreotide in idiopathic pulmonary fibrosis. J Nucl Med. 2006 Aug;47(8):1281-7.

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