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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT00463983
First received: April 18, 2007
Last updated: September 20, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Idiopathic Pulmonary Fibrosis
 Drug: octreotide
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Long Acting Octreotide in Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • FVC changes [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • DLCO changes [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: October 2006
Study Completion Date: January 2012
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: octreotide
octreotide SR 30 mg intra muscularly every 4 weeks
 Drug: octreotide

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463983

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

Publications:

Additional 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
Study First Received: April 18, 2007
Last Updated: September 20, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on May 19, 2013