Treatment of Idiopathic Pulmonary Fibrosis with Long Acting Octreotide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Study Groups

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octreotide

octreotide SR 30 mg intra muscularly every 4 weeks

Group Type EXPERIMENTAL

octreotide

Intervention Type DRUG

Interventions

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octreotide

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No