DRUG
Treatment of Idiopathic Pulmonary Fibrosis With Long Acting Octreotide
Status
Completed
Phase
Phase 1 / Phase 2
Enrollment
25
Locations
16
Results
Not posted
Publications
2
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Apr 20, 2007
Study start
Oct 2006
Primary completion
Jan 2010
Study completion
Jan 2012
Results posted
Not reported
Registry updated
Mar 5, 2025
Outcomes
What the study measures.
Primary outcomes
FVC changes
Time frame · 12 months
Secondary outcomes
DLCO changes
Time frame · 12 months
Eligibility
Who can take part.
- Minimum age
- 40 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
16 registered sites.
France. Showing up to 24 locations stored in the fast local snapshot.
Service de Pneumologie Hôpital Avicenne 125 rue de Stalingrad
Bobigny, France
Service de Pneumologie Hôpital Ambroise Paré
Boulogne-Billancourt, France
Service de Pneumologie Hôpital Côte de Nacre
Caen, France
Service de Pneumologie Hôpital Antoine Béclère
Clamart, France
Service de Pneumologie Centre hospitalier intercommunal de Créteil
Créteil, France
Service de Pneumologie Hôpital Albert calmette
Lille, France
Service de Pneumologie Hôpital Sainte Marguerite BP 29
Marseille, France
Service de Pneumologie Hôpital Saint-Antoine
Paris, France
Hôpital Bichat 46 rue Henri Huchard
Paris, France
Service de Pneumologie A Hôpital Bichat 1
Paris, France
Service de Pneumologie Hôpital Saint Louis 1 avenue Claude-Vellefaux
Paris, France
Service de Pneumologie Hôpital de la Pitié-Salpetrière 47-83 boulevard de l'hôpital
Paris, France
Service de Pneumologie Hôpital Cochin
Paris, France
Service de Pneumologie Hôpital Georges Pompidou
Paris, France
Service de Pneumologie A Hôpital Tenon
Paris, France
Service de Pneumologie Hôpital Pontchaillou
Rennes, France
Publications
Results and literature.
PMID 22379151 ↗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 16883006 ↗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.
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