Clinical trial NCT00463983: Treatment of Idiopathic Pulmonary Fibrosis with Long Acting Octreotide
Official title: Phase 2 Study of Long Acting Octreotide in Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2007-04-20
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: FVC changes
timeFrame: 12 months
Secondary outcomes:
measure: DLCO changes
timeFrame: 12 months
Other outcomes:
Locations:
city: Bobigny Cedex
country: France
facility: Service de Pneumologie Hôpital Avicenne 125 rue de Stalingrad
city: Boulogne-Billancourt
country: France
facility: Service de Pneumologie Hôpital Ambroise Paré
city: Caen
country: France
facility: Service de Pneumologie Hôpital Côte de Nacre
city: Clamart
country: France
facility: Service de Pneumologie Hôpital Antoine Béclère
city: Creteil
country: France
facility: Service de Pneumologie Centre hospitalier intercommunal de Créteil
city: Lille Cedex
country: France
facility: Service de Pneumologie Hôpital Albert calmette
city: Marseille Cedex 09
country: France
facility: Service de Pneumologie Hôpital Sainte Marguerite BP 29
city: Paris Cedex 10
country: France
facility: Service de Pneumologie Hôpital Saint Louis 1 avenue Claude-Vellefaux
city: Paris Cedex 13
country: France
facility: Service de Pneumologie Hôpital de la Pitié-Salpetrière 47-83 boulevard de l'hôpital
city: Paris Cedex 14
country: France
facility: Service de Pneumologie Hôpital Cochin
city: Paris Cedex 15
country: France
facility: Service de Pneumologie Hôpital Georges Pompidou
city: Paris Cedex 20
country: France
facility: Service de Pneumologie A Hôpital Tenon
city: Paris
country: France
facility: Service de Pneumologie Hôpital Saint-Antoine
city: Paris
country: France
facility: Hôpital Bichat 46 rue Henri Huchard
city: Paris
country: France
facility: Service de Pneumologie A Hôpital Bichat 1
city: Rennes
country: France
facility: Service de Pneumologie Hôpital Pontchaillou
Study officials:
affiliation: INSERM, France
name: Bruno Crestani, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.