NCT00463983

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_1

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 5, 2025

Status Verified

February 1, 2025

Enrollment Period

3.3 years

First QC Date

April 18, 2007

Last Update Submit

February 28, 2025

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

  • FVC changes

    12 months

Secondary Outcomes (1)

  • DLCO changes

    12 months

Study Arms (1)

octreotide

EXPERIMENTAL

octreotide SR 30 mg intra muscularly every 4 weeks

Drug: octreotide

Interventions

octreotideDRUG
octreotide

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • confident diagnosis of IPF according to ATS/ERS criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Service de Pneumologie Hôpital Avicenne 125 rue de Stalingrad

Bobigny, 93009, France

Location

Service de Pneumologie Hôpital Ambroise Paré

Boulogne-Billancourt, 92100, France

Location

Service de Pneumologie Hôpital Côte de Nacre

Caen, 14000, France

Location

Service de Pneumologie Hôpital Antoine Béclère

Clamart, 92140, France

Location

Service de Pneumologie Centre hospitalier intercommunal de Créteil

Créteil, 94010, France

Location

Service de Pneumologie Hôpital Albert calmette

Lille, 59037, France

Location

Service de Pneumologie Hôpital Sainte Marguerite BP 29

Marseille, 13274, France

Location

Service de Pneumologie Hôpital Saint-Antoine

Paris, 75012, France

Location

Hôpital Bichat 46 rue Henri Huchard

Paris, 75018, France

Location

Service de Pneumologie A Hôpital Bichat 1

Paris, 75018, France

Location

Service de Pneumologie Hôpital Saint Louis 1 avenue Claude-Vellefaux

Paris, 75475, France

Location

Service de Pneumologie Hôpital de la Pitié-Salpetrière 47-83 boulevard de l'hôpital

Paris, 75651, France

Location

Service de Pneumologie Hôpital Cochin

Paris, 75679, France

Location

Service de Pneumologie Hôpital Georges Pompidou

Paris, 75908, France

Location

Service de Pneumologie A Hôpital Tenon

Paris, 75970, France

Location

Service de Pneumologie Hôpital Pontchaillou

Rennes, 35000, France

Location

Related Publications (2)

  • 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.

    PMID: 22379151BACKGROUND

  • 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.

    PMID: 16883006BACKGROUND

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Bruno Crestani, MD, PhD

    INSERM, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2007

First Posted

April 20, 2007

Study Start

October 1, 2006

Primary Completion

January 1, 2010

Study Completion

January 1, 2012

Last Updated

March 5, 2025

Record last verified: 2025-02

Locations

FR(16)