NCT00477074

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
Last Updated

May 22, 2007

Status Verified

May 1, 2007

First QC Date

May 18, 2007

Last Update Submit

May 18, 2007

Conditions

Keywords

chronic obstructive pulmonary diseaseemphysemainflammationrepair

Interventions

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Acute exacerbation last three months
  • Chronic lung diseases (asthma, bronchiectasis and interstitial lung diseases) and cardiac, hepatic or renal failure.
  • Systemic steroid treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servei Pneumologia. Hospital Universitari Son Dureta

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Related Publications (7)

  • 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.

    PMID: 16216128BACKGROUND
  • Sugahara 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.

    PMID: 9660257BACKGROUND
  • Shigemura 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.

    PMID: 15764723BACKGROUND
  • Plantier 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.

    PMID: 15579628BACKGROUND
  • Mason 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.

    PMID: 11970901BACKGROUND
  • Stern 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.

    PMID: 10921560BACKGROUND
  • Welsh 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.

    PMID: 10988134BACKGROUND

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmphysemaInflammation

Interventions

Bronchoalveolar LavageHematologic Tests

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutic IrrigationInvestigative TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Jaume Sauleda

    Hospital Universitari Son Dureta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 18, 2007

First Posted

May 22, 2007

Study Start

January 1, 2004

Study Completion

December 1, 2005

Last Updated

May 22, 2007

Record last verified: 2007-05

Locations