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OpenTrials
Completed

NCT Number: NCT00463983

Treatment of Idiopathic Pulmonary Fibrosis With Long Acting Octreotide

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Service de Pneumologie Hôpital Avicenne 125 rue de Stalingrad, Bobigny, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Octreotide

Drug

Primary outcomes

  1. FVC changes

    Time frame: 12 months

Secondary outcomes

  1. DLCO changes

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Official study title

Phase 2 Study of Long Acting Octreotide in Idiopathic Pulmonary Fibrosis

Acronym: FIBROSAND

Important dates

Study start
2006
Primary completion
2010
Study completion
2012
First posted
Apr 20, 2007
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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