Characterization of the Pathobiology of Early Lung Destru... | NCT00001462

Studies
Characterization of the Pathobiology of Early Lung Destruction in Alpha 1-Antitrypsin Deficient Individuals

NCT00001462

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Status

Completed

Last Update Posted

Mar 4, 2008Estimated

Enrollment

Phase

Not provided

Conditions

Emphysema
Lung Diseases, Obstructive
Alpha 1-Antitrypsin Deficiency

Interventions

Not provided

Countries

United States

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

ID	Type	Description	Link
95-H-0116

Status Module

Record Verification Date

Aug 1999

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

May 1995

Primary Completion Date

Not provided

Completion Date

Apr 2000

First Submitted Date

Nov 3, 1999

First Submission Date that Met QC Criteria

Dec 9, 2002

First Posted Date

Dec 10, 2002Estimated

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

Mar 3, 2008

Last Update Posted Date

Mar 4, 2008Estimated

Description Module

Brief Summary

Alpha 1-antitrypsin-deficient individuals develop severe destructive lung disease much earlier and their lung function declines faster than the general population of individuals with chronic obstructive lung disease. This study is designed to better understand the pathogenesis of lung destruction in alpha 1-antitrypsin deficient individuals and to characterize the pathobiology of early lung destruction. To accomplish this we intend to use bronchoalveolar lavage to determine and quantify the factors that initiate and sustain lung inflammation in alpha 1-antitrypsin deficient individuals with lung function above a force expiratory volume in one second (FEV1) of greater than 50% of predicted.

Detailed Description

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Eligibility Module

Eligibility Criteria

Any alpha 1 antitrypsin-deficient individuals.

18-65 years old.

FEV1 greater than 1 equal to 50 percent of predicted (forced expiratory volume).

Study participation is required for one year.

A total of four bronchoscopies will be performed over a year period.

Methacholine challenge test will be performed at the beginning and end of the study to assess the degree of reactive airways disease.

Pneumococcal and annual influenza vaccine will be given.

No prolastin within one year prior to start of the study.

No oral systemic corticosteroids within 30 days prior to start of study.

No allergy to topical or local anesthetic (i.e., lidocaine).

No pregnancy.

No HIV positive patients.

No Hepatitis B/C virus positive patients.

No patients with any condition associated with immunodeficiency.

No patients with presence of significant cardiac diseases.

No patients with presence of uncorrected blood-clotting disorders.

No patients with any oxygen at home on a regular basis.

No adverse reactions to methacholine.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
National Heart, Lung and Blood Institute (NHLBI)		Bethesda	Maryland	20892	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
2497126	Background	Buist AS. Alpha 1-antitrypsin deficiency in lung and liver disease. Hosp Pract (Off Ed). 1989 May 15;24(5):51-9. doi: 10.1080/21548331.1989.11703712. No abstract available.
2185272	Background	Crystal RG. Alpha 1-antitrypsin deficiency, emphysema, and liver disease. Genetic basis and strategies for therapy. J Clin Invest. 1990 May;85(5):1343-52. doi: 10.1172/JCI114578. No abstract available.

ID	Term
D004646	Emphysema
D008173	Lung Diseases, Obstructive
D019896	alpha 1-Antitrypsin Deficiency
D030342	Genetic Diseases, Inborn
D007249	Inflammation

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases