Pulmonary and Systemic Hepatocyte Growth Factors in Patie... | NCT00477074

Studies
Pulmonary and Systemic Hepatocyte Growth Factors in Patients With COPD

NCT00477074

Sponsor

Hospital Universitari Son Dureta

Status

Completed

Last Update Posted

May 22, 2007Estimated

Enrollment

44Actual

Phase

Not provided

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

bronchoalveolar lavage, blood analysis

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Not provided

Completion Date

Dec 2005Actual

First Submitted Date

May 18, 2007

First Submission Date that Met QC Criteria

May 18, 2007

First Posted Date

May 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2007

Last Update Posted Date

May 22, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Hospital Universitari Son DuretaOTHER

Collaborators

Name	Class
Sociedad Española de Neumología y Cirugía Torácica	OTHER
Fundacion Caubet-Cimera Islas Baleares	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Name	Type	Description	Arm Group Labels	Other Names
bronchoalveolar lavage, blood analysis	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jaume Sauleda	Hospital Universitari Son Dureta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Servei Pneumologia. Hospital Universitari Son Dureta		Palma de Mallorca	Balearic Islands	07014	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16216128	Background	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.
9660257	Background	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.

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D004646	Emphysema
D007249	Inflammation

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

ID	Term
D018893	Bronchoalveolar Lavage
D006403	Hematologic Tests

ID	Term
D007507	Therapeutic Irrigation
D008919	Investigative Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures