Idiopathic Pulmonary Fibrosis
Conditions
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.
Interventions
DRUGoctreotide
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FVC changes | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| DLCO changes | 12 months |
Countries
France
Outcome results
None listed