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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
octreotide
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    octreotide

    Arm Description

    octreotide SR 30 mg intra muscularly every 4 weeks

    Outcomes

    Primary Outcome Measures

    FVC changes

    Secondary Outcome Measures

    DLCO changes

    Full Information

    First Posted
    April 18, 2007
    Last Updated
    September 20, 2012
    Sponsor
    Institut National de la Santé Et de la Recherche Médicale, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00463983
    Brief Title
    Treatment of Idiopathic Pulmonary Fibrosis With Long Acting Octreotide
    Acronym
    FIBROSAND
    Official Title
    Phase 2 Study of Long Acting Octreotide in Idiopathic Pulmonary Fibrosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2006 (undefined)
    Primary Completion Date
    January 2010 (Actual)
    Study Completion Date
    January 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institut National de la Santé Et de la Recherche Médicale, France

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Idiopathic Pulmonary Fibrosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    octreotide
    Arm Type
    Experimental
    Arm Description
    octreotide SR 30 mg intra muscularly every 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    octreotide
    Primary Outcome Measure Information:
    Title
    FVC changes
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    DLCO changes
    Time Frame
    12 months
    Other Pre-specified Outcome Measures:
    Title
    safety
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bruno Crestani, MD, PhD
    Organizational Affiliation
    INSERM, France
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16883006
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22379151
    Citation
    Crestani B, Chapron J, Wallaert B, Bergot E, Delaval P, Israel-Biet D, Lacronique J, Monnet I, Reynaud-Gaubert M, Tazi A, Lebtahi R, Debray MP, Brauner M, Dehoux M, Dornic Q, Aubier M, Mentre F, Duval X. Octreotide treatment of idiopathic pulmonary fibrosis: a proof-of-concept study. Eur Respir J. 2012 Mar;39(3):772-5. doi: 10.1183/09031936.00113011. No abstract available.
    Results Reference
    derived

    Learn more about this trial

    Treatment of Idiopathic Pulmonary Fibrosis With Long Acting Octreotide

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