Treatment of Idiopathic Pulmonary Fibrosis With Long Acting Octreotide

Idiopathic Pulmonary Fibrosis Clinical Trial

— FIBROSAND  

Official title:

Phase 2 Study of Long Acting Octreotide in Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00463983
• Other study ID #: C05-32
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 18, 2007
• Last updated: September 20, 2012
• Start date: October 2006
• Est. completion date: January 2012

Study information

• Verified date: September 2012
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2012
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• octreotide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	safety		12 months	Yes
Primary	FVC changes		12 months	No
Secondary	DLCO changes		12 months	No