Chronic Obstructive Pulmonary DiseaseNCT00477074
Pulmonary and Systemic Hepatocyte Growth Factors in Patients With COPD
An observational study of Chronic Obstructive Pulmonary Disease, run by Hospital Universitari Son Dureta at 1 site in Spain.
Trial summary
The role of HGF and KGF in COPD is poorly known. Plantier et al found that cultured fibroblasts harvested from patients with emphysema produced less HGF (but similar amounts of KGF) than controls, and Bonay et al found a direct relationship between the severity of airflow obstruction and HGF mRNA content in lung… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- bronchoalveolar lavage, blood analysis
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2004to Dec 2005
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with COPD (GOLD II-III) 1, smokers without chronic bronchitis or dyspnea and with normal lung function, and never smokers who required bronchoscopy for clinical purposes.
Who cannot join
- Acute exacerbation last three months
- Chronic lung diseases (asthma, bronchiectasis and interstitial lung diseases) and cardiac, hepatic or renal failure.
- Systemic steroid treatment
Trial locations and contacts
1 site in 1 country.
Spain1 site
Servei Pneumologia. Hospital Universitari Son Dureta
Palma de Mallorca, Balearic Islands, 07014
About this study
Official title: Pulmonary and Systemic Hepatocyte Anb Keratinocyte Growth Factors in Patients With Chronic Obstructive Pulmonary Disease
The role of HGF and KGF in COPD is poorly known. Plantier et al found that cultured fibroblasts harvested from patients with emphysema produced less HGF (but similar amounts of KGF) than controls, and Bonay et al found a direct relationship between the severity of airflow obstruction and HGF mRNA content in lung samples of smokers. These two studies suggest, therefore, that the pulmonary regulation of HGF may be abnormal in patients with COPD. However, both HGF and KGF can also be released by extra-pulmonary organs, thus having the potential to act systemically. Given the current clinical relevance attributed to the systemic effects of COPD, in this study we compared the levels of HGF and KGF in the pulmonary (bronchoalveolar lavage (BAL) fluid) and systemic compartment (circulating blood) of smokers with and without COPD and never smokers.
Read the detailed description
Background: The potential role of growth factors in COPD has begun to be addressed only recently and is still poorly understood. In this study we investigate potential abnormalities of hepatocyte growth factor (HGF) and keratinocyte growth factor (KGF) in patients with COPD.
Methods: To this end, we compared the levels of HGF and KGF, measured by ELISA, in bronchoalveolar lavage (BAL) fluid and in serum in 18 patients with COPD (62 ± 2 yrs, FEV1 57 ± 4% ref, X ± SEM), 18 smokers with normal lung function (58 ± 2 yrs., FEV1 90 ± 4% ref) and 8 never smokers (67 ± 7 yrs, 94 ± 4% ref).
Results: We found that, in BAL, HGF levels were higher in patients with COPD than in the other two groups whereas, in serum, HGF concentration was highest in smokers with normal lung function (p<0.01). KGF levels were not significantly different between groups, neither in blood nor in BAL, (most values were below the detection limit).
Conclusions: These results highlight a different response of HGF in BAL and serum in smokers with and without COPD that may be relevant for tissue repair in COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- bronchoalveolar lavage, blood analysis
- Keywords
- chronic obstructive pulmonary disease, emphysema, inflammation, repair
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoalveolar lavage, blood analysisProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startJan 2004
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Son Dureta
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedad Española de Neumología y Cirugía Torácica, Fundacion Caubet-Cimera Islas Baleares
- Investigators
- Jaume Sauleda, Principal investigator, Hospital Universitari Son Dureta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477074
- Sponsor's protocol ID
- SEPAR2002FG
- Status last verified
- May 2007
- First submitted
- 18 May 2007
- Last updated
- 22 May 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Bonay M, Boutten A, Lecon-Malas V, Marchal J, Soler P, Fournier M, Leseche G, Dehoux M, Crestani B. Hepatocyte and keratinocyte growth factors and their receptors in human lung emphysema. BMC Pulm Med. 2005 Oct 10;5:13. doi: 10.1186/1471-2466-5-13.
PubMed 16216128Sugahara K, Matsumoto M, Baba T, Nakamura T, Kawamoto T. Elevation of serum human hepatocyte growth factor (HGF) level in patients with pneumonectomy during a perioperative period. Intensive Care Med. 1998 May;24(5):434-7. doi: 10.1007/s001340050592.
PubMed 9660257Shigemura N, Sawa Y, Mizuno S, Ono M, Minami M, Okumura M, Nakamura T, Kaneda Y, Matsuda H. Induction of compensatory lung growth in pulmonary emphysema improves surgical outcomes in rats. Am J Respir Crit Care Med. 2005 Jun 1;171(11):1237-45. doi: 10.1164/rccm.200411-1518OC. Epub 2005 Mar 11.
PubMed 15764723Plantier L, Marchand-Adam S, Marchal-Somme J, Leseche G, Fournier M, Dehoux M, Aubier M, Crestani B. Defect of hepatocyte growth factor production by fibroblasts in human pulmonary emphysema. Am J Physiol Lung Cell Mol Physiol. 2005 Apr;288(4):L641-7. doi: 10.1152/ajplung.00249.2004. Epub 2004 Dec 3.
PubMed 15579628Mason RJ. Hepatocyte growth factor: the key to alveolar septation? Am J Respir Cell Mol Biol. 2002 May;26(5):517-20. doi: 10.1165/ajrcmb.26.5.f239. No abstract available.
PubMed 11970901Stern JB, Fierobe L, Paugam C, Rolland C, Dehoux M, Petiet A, Dombret MC, Mantz J, Aubier M, Crestani B. Keratinocyte growth factor and hepatocyte growth factor in bronchoalveolar lavage fluid in acute respiratory distress syndrome patients. Crit Care Med. 2000 Jul;28(7):2326-33. doi: 10.1097/00003246-200007000-00024.
PubMed 10921560Welsh DA, Summer WR, Dobard EP, Nelson S, Mason CM. Keratinocyte growth factor prevents ventilator-induced lung injury in an ex vivo rat model. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):1081-6. doi: 10.1164/ajrccm.162.3.9908099.
PubMed 10988134
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary and Systemic Hepatocyte Anb Keratinocyte Growth Factors in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00477074
- Acronym / sponsor ID
- SEPAR2002FG
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease, emphysema, inflammation, repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Hospital Universitari Son DuretaUniversity, hospital or other
- Collaborators
- Sociedad Española de Neumología y Cirugía Torácica, Fundacion Caubet-Cimera Islas Baleares
- Study start
- Jan 2004
- Study completion
- Dec 2005 (actual)
- First posted
- 22 May 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.
The role of HGF and KGF in COPD is poorly known. Plantier et al found that cultured fibroblasts harvested from patients with emphysema produced less HGF (but similar amounts of KGF) than controls, and Bonay et al found a direct relationship between the severity of airflow obstruction and HGF mRNA content in lung samples of smokers. These two studies suggest, therefore, that the pulmonary regulation of HGF may be abnormal in patients with COPD. However, both HGF and KGF can also be released by extra-pulmonary organs, thus having the potential to act systemically. Given the current clinical relevance attributed to the systemic effects of COPD, in this study we compared the levels of HGF and KGF in the pulmonary (bronchoalveolar lavage (BAL) fluid) and systemic compartment (circulating blood) of smokers with and without COPD and never smokers.
Detailed description
Background: The potential role of growth factors in COPD has begun to be addressed only recently and is still poorly understood. In this study we investigate potential abnormalities of hepatocyte growth factor (HGF) and keratinocyte growth factor (KGF) in patients with COPD.
Methods: To this end, we compared the levels of HGF and KGF, measured by ELISA, in bronchoalveolar lavage (BAL) fluid and in serum in 18 patients with COPD (62 ± 2 yrs, FEV1 57 ± 4% ref, X ± SEM), 18 smokers with normal lung function (58 ± 2 yrs., FEV1 90 ± 4% ref) and 8 never smokers (67 ± 7 yrs, 94 ± 4% ref).
Results: We found that, in BAL, HGF levels were higher in patients with COPD than in the other two groups whereas, in serum, HGF concentration was highest in smokers with normal lung function (p<0.01). KGF levels were not significantly different between groups, neither in blood nor in BAL, (most values were below the detection limit).
Conclusions: These results highlight a different response of HGF in BAL and serum in smokers with and without COPD that may be relevant for tissue repair in COPD.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with COPD (GOLD II-III) 1, smokers without chronic bronchitis or dyspnea and with normal lung function, and never smokers who required bronchoscopy for clinical purposes.
Key exclusion criteria (3 listed)
- Acute exacerbation last three months
- Chronic lung diseases (asthma, bronchiectasis and interstitial lung diseases) and cardiac, hepatic or renal failure.
- Systemic steroid treatment
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 |
|---|---|---|
| bronchoalveolar lavage, blood analysis | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 22 May 2007.
- Background: PubMed 16216128Bonay M, Boutten A, Lecon-Malas V, Marchal J, Soler P, Fournier M, Leseche G, Dehoux M, Crestani B. Hepatocyte and keratinocyte growth factors and their receptors in human lung emphysema. BMC Pulm Med. 2005 Oct 10;5:13. doi: 10.1186/1471-2466-5-13.
- Background: PubMed 9660257Sugahara K, Matsumoto M, Baba T, Nakamura T, Kawamoto T. Elevation of serum human hepatocyte growth factor (HGF) level in patients with pneumonectomy during a perioperative period. Intensive Care Med. 1998 May;24(5):434-7. doi: 10.1007/s001340050592.
- Background: PubMed 15764723Shigemura N, Sawa Y, Mizuno S, Ono M, Minami M, Okumura M, Nakamura T, Kaneda Y, Matsuda H. Induction of compensatory lung growth in pulmonary emphysema improves surgical outcomes in rats. Am J Respir Crit Care Med. 2005 Jun 1;171(11):1237-45. doi: 10.1164/rccm.200411-1518OC. Epub 2005 Mar 11.
- Background: PubMed 15579628Plantier L, Marchand-Adam S, Marchal-Somme J, Leseche G, Fournier M, Dehoux M, Aubier M, Crestani B. Defect of hepatocyte growth factor production by fibroblasts in human pulmonary emphysema. Am J Physiol Lung Cell Mol Physiol. 2005 Apr;288(4):L641-7. doi: 10.1152/ajplung.00249.2004. Epub 2004 Dec 3.
- Background: PubMed 11970901Mason RJ. Hepatocyte growth factor: the key to alveolar septation? Am J Respir Cell Mol Biol. 2002 May;26(5):517-20. doi: 10.1165/ajrcmb.26.5.f239. No abstract available.
- Background: PubMed 10921560Stern JB, Fierobe L, Paugam C, Rolland C, Dehoux M, Petiet A, Dombret MC, Mantz J, Aubier M, Crestani B. Keratinocyte growth factor and hepatocyte growth factor in bronchoalveolar lavage fluid in acute respiratory distress syndrome patients. Crit Care Med. 2000 Jul;28(7):2326-33. doi: 10.1097/00003246-200007000-00024.
- Background: PubMed 10988134Welsh DA, Summer WR, Dobard EP, Nelson S, Mason CM. Keratinocyte growth factor prevents ventilator-induced lung injury in an ex vivo rat model. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):1081-6. doi: 10.1164/ajrccm.162.3.9908099.
- Spanish Respiratory SocietyLink provided by the sponsor.
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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.
Jaume Sauleda principal investigator
Hospital Universitari Son Dureta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Hospital Universitari Son Dureta at 1 site in Spain.
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 3 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 22 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00477074, which also lists 7 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 22 May 2007.