Treatment of Idiopathic Pulmonary Fibrosis with Long Acting Octreotide
- Registration Number
- NCT00463983
- Lead Sponsor
- Institut National de la Sant茅 Et de la Recherche M茅dicale, France
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- confident diagnosis of IPF according to ATS/ERS 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description octreotide octreotide octreotide SR 30 mg intra muscularly every 4 weeks
- Primary Outcome Measures
Name Time Method FVC changes 12 months
- Secondary Outcome Measures
Name Time Method DLCO changes 12 months
Trial Locations
- Locations (16)
Service de Pneumologie H么pital Avicenne 125 rue de Stalingrad
馃嚝馃嚪Bobigny Cedex, France
Service de Pneumologie H么pital Ambroise Par茅
馃嚝馃嚪Boulogne-Billancourt, France
Service de Pneumologie H么pital C么te de Nacre
馃嚝馃嚪Caen, France
Service de Pneumologie H么pital Antoine B茅cl猫re
馃嚝馃嚪Clamart, France
Service de Pneumologie Centre hospitalier intercommunal de Cr茅teil
馃嚝馃嚪Creteil, France
Service de Pneumologie H么pital Cochin
馃嚝馃嚪Paris Cedex 14, France
Service de Pneumologie H么pital Albert calmette
馃嚝馃嚪Lille Cedex, France
Service de Pneumologie H么pital de la Piti茅-Salpetri猫re 47-83 boulevard de l'h么pital
馃嚝馃嚪Paris Cedex 13, France
Service de Pneumologie H么pital Sainte Marguerite BP 29
馃嚝馃嚪Marseille Cedex 09, France
Service de Pneumologie H么pital Saint Louis 1 avenue Claude-Vellefaux
馃嚝馃嚪Paris Cedex 10, France
Service de Pneumologie H么pital Georges Pompidou
馃嚝馃嚪Paris Cedex 15, France
Service de Pneumologie A H么pital Tenon
馃嚝馃嚪Paris Cedex 20, France
Service de Pneumologie H么pital Saint-Antoine
馃嚝馃嚪Paris, France
H么pital Bichat 46 rue Henri Huchard
馃嚝馃嚪Paris, France
Service de Pneumologie A H么pital Bichat 1
馃嚝馃嚪Paris, France
Service de Pneumologie H么pital Pontchaillou
馃嚝馃嚪Rennes, France