NCT Number: NCT00463983
Treatment of Idiopathic Pulmonary Fibrosis With Long Acting Octreotide
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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Notify MeKey information
Conditions
Age range
40 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
Service de Pneumologie Hôpital Avicenne 125 rue de Stalingrad, Bobigny, France
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
FVC changes
Time frame: 12 months
Secondary outcomes
-
DLCO changes
Time frame: 12 months
Sponsors and collaborators
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Other Gov
Registry information
Official study title
Phase 2 Study of Long Acting Octreotide in Idiopathic Pulmonary Fibrosis
Acronym: FIBROSAND
Important dates
- Study start
- 2006
- Primary completion
- 2010
- Study completion
- 2012
- First posted
- Apr 20, 2007
- Registry last updated
- Mar 5, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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