Genetic Determinants of the Bronchodilatation Effect of Albuterol ex-Vivo

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00162422
• Collaborator: (none)
• Enrollment: 150
• Location: 1

Study Details

Study Description

Brief Summary

The role played by ß2AR polymorphisms in determining the bronchial response to ß2AR agonist drugs, has been confirmed by several studies.

The purpose of the present study is to examine possible causal relationships between genetically based alteration in the structure of ß2AR and drug responsiveness. An ex-vivo model (organ bath technique) will be used to investigate association between polymorphisms in the coding region of ß2AR and the response of bronchial rings derived from human lung tissue to the respective agonists (i.e. salbutamol).

In the second part of the study the same bronchial rings will be incubated for 24 hours in a solution containing fixed concentration of albuterol. A second dose response curve for rising concentrations of albuterol will be constructed and a relationship between β2 genetic polymorphisms and the extent of desensitization to albuterol will be investigated.

In addition, through specifically designed receptor binding assay the bronchial tissue will be used to define the affinity (Kd) and expression (Vmax) of the ß2 receptor. These data will enable to enhance our understanding regarding the mechanism responsible for the association noted between ß2AR polymorphism and altered drug effect.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: albuterol	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of β2 Genetic Polymorphisms on the Brochodilatation Effect of Albuterol ex-Vivo
• Study Start Date: Aug 1, 2003

Outcome Measures

Primary Outcome Measures

1. The extent of bronchial dilatation ex-vivo []

2. The extent of decrease in brochial dilatation after prolonged incubation with albuterol []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Macroscopically normal pulmonary tissue

Exclusion Criteria:

• The presence of pathological finding in the pulmonary tissue

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Organization	Jerusalem		Israel

Sponsors and Collaborators

• Hadassah Medical Organization

Investigators

• Principal Investigator: Yoseph Caraco, ND, Hadassah Medical Organization

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00162422
• Other Study ID Numbers: yc19557-HMO-CTIL
• First Posted: Sep 13, 2005
• Last Update Posted: Oct 29, 2008
• Last Verified: Oct 1, 2008

• Additional relevant MeSH terms: Albuterol

Study Results

No Results Posted as of Oct 29, 2008