Treatment of Idiopathic Pulmonary Fibrosis With Long Acting Octreotide - Full Text View

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

This study has been completed.

Sponsored by:	Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:	Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:	NCT00463983

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 I Phase II

MedlinePlus related topics: Pulmonary Fibrosis

Drug Information available for: Octreotide Octreotide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 2 Study of Long Acting Octreotide in Idiopathic Pulmonary Fibrosis

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

Estimated Enrollment:	25
Study Start Date:	October 2006

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

Locations

France
Hopital Bichat, Service de Pneumologie
Paris, France, 75018

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:

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.

Study ID Numbers:	C-05-32
Study First Received:	April 18, 2007
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00463983
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Lung Diseases, Interstitial
Respiratory Tract Diseases
Fibrosis
Hamman-Rich syndrome

Lung Diseases
Octreotide
Pulmonary Fibrosis

Additional relevant MeSH terms:

Pathologic Processes
Antineoplastic Agents, Hormonal
Antineoplastic Agents

Therapeutic Uses
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009