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

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ClinicalTrials.gov Identifier: NCT00463983
Recruitment Status : Completed
First Posted : April 20, 2007
Last Update Posted : September 21, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: octreotide Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Long Acting Octreotide in Idiopathic Pulmonary Fibrosis
Study Start Date : October 2006
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2012


Arm Intervention/treatment
Experimental: octreotide
octreotide SR 30 mg intra muscularly every 4 weeks
Drug: octreotide



Primary Outcome Measures :
  1. FVC changes [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. DLCO changes [ Time Frame: 12 months ]

Other Outcome Measures:
  1. safety [ Time Frame: 12 months ]


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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00463983


Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Bruno Crestani, MD, PhD INSERM, France

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT00463983     History of Changes
Other Study ID Numbers: C05-32
First Posted: April 20, 2007    Key Record Dates
Last Update Posted: September 21, 2012
Last Verified: September 2012

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents