Idiopathic Pulmonary FibrosisPhase 1/2FIBROSANDNCT00463983
Treatment of Idiopathic Pulmonary Fibrosis With Long Acting Octreotide
A Phase 1/2 study testing octreotide in people with Idiopathic Pulmonary Fibrosis, run by Institut National de la Santé Et de la Recherche Médicale, France at 16 sites in France.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- octreotide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 16 sitesFrance
- Study dates
- Oct 2006to Jan 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confident diagnosis of IPF according to ATS/ERS criteria
Who cannot join
- 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
Show all 10Show fewer
- symptomatic biliary lithiasis
- blood coagulation disorders that prevent intra-muscular injections
- HIV infection
- hepatitis B or C active infection
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
Service de Pneumologie Hôpital Avicenne 125 rue de Stalingrad
Bobigny, 93009
Service de Pneumologie Hôpital Ambroise Paré
Boulogne-Billancourt, 92100
Service de Pneumologie Hôpital Côte de Nacre
Caen, 14000
Service de Pneumologie Hôpital Antoine Béclère
Clamart, 92140
Service de Pneumologie Centre hospitalier intercommunal de Créteil
Créteil, 94010
Service de Pneumologie Hôpital Albert calmette
Lille, 59037
Service de Pneumologie Hôpital Sainte Marguerite BP 29
Marseille, 13274
Service de Pneumologie Hôpital Saint-Antoine
Paris, 75012
Hôpital Bichat 46 rue Henri Huchard
Paris, 75018
Service de Pneumologie A Hôpital Bichat 1
Paris, 75018
Service de Pneumologie Hôpital Saint Louis 1 avenue Claude-Vellefaux
Paris, 75475
Service de Pneumologie Hôpital de la Pitié-Salpetrière 47-83 boulevard de l'hôpital
Paris, 75651
Service de Pneumologie Hôpital Cochin
Paris, 75679
Service de Pneumologie Hôpital Georges Pompidou
Paris, 75908
Service de Pneumologie A Hôpital Tenon
Paris, 75970
Service de Pneumologie Hôpital Pontchaillou
Rennes, 35000
About this study
Official title: Phase 2 Study of Long Acting Octreotide in Idiopathic Pulmonary Fibrosis
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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- octreotide
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
octreotideDrug
| Study group | Role | What they receive |
|---|---|---|
| octreotide | Experimental | octreotide SR 30 mg intra muscularly every 4 weeks Receives: Drug: octreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
FVC changes
Measured: 12 months
Secondary outcomes (1)
DLCO changes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startOct 2006
- Primary completionJan 2010
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Bruno Crestani, MD, PhD, Principal investigator, INSERM, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463983
- Sponsor's protocol ID
- C05-32
- Acronym
- FIBROSAND
- Status last verified
- Feb 2025
- First submitted
- 18 Apr 2007
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Crestani B, Chapron J, Wallaert B, Bergot E, Delaval P, Israel-Biet D, Lacronique J, Monnet I, Reynaud-Gaubert M, Tazi A, Lebtahi R, Debray MP, Brauner M, Dehoux M, Dornic Q, Aubier M, Mentre F, Duval X. Octreotide treatment of idiopathic pulmonary fibrosis: a proof-of-concept study. Eur Respir J. 2012 Mar;39(3):772-5. doi: 10.1183/09031936.00113011. No abstract available.
PubMed 22379151Lebtahi 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.
PubMed 16883006
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Long Acting Octreotide in Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT00463983
- Acronym / sponsor ID
- FIBROSAND / C05-32
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Oct 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 20 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| octreotide | Experimental | Drug: octreotideoctreotide SR 30 mg intra muscularly every 4 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- confident diagnosis of IPF according to ATS/ERS criteria
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| octreotide | Drug | octreotide |
Primary outcome
FVC changes
Time frame: 12 months
1 secondary outcome
DLCO changes
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Results publication: PubMed 22379151Crestani B, Chapron J, Wallaert B, Bergot E, Delaval P, Israel-Biet D, Lacronique J, Monnet I, Reynaud-Gaubert M, Tazi A, Lebtahi R, Debray MP, Brauner M, Dehoux M, Dornic Q, Aubier M, Mentre F, Duval X. Octreotide treatment of idiopathic pulmonary fibrosis: a proof-of-concept study. Eur Respir J. 2012 Mar;39(3):772-5. doi: 10.1183/09031936.00113011. No abstract available.
- Results publication: PubMed 16883006Lebtahi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Crestani, MD, PhD principal investigator
INSERM, France
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing octreotide in people with Idiopathic Pulmonary Fibrosis, run by Institut National de la Santé Et de la Recherche Médicale, France at 16 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FVC changes (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00463983, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.