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NCT00162422 Clinical Trial

Genetic Determinants of the Bronchodilatation Effect of Albuterol ex-Vivo

Asthma Clinical Trial

Official title:
The Effect of β2 Genetic Polymorphisms on the Brochodilatation Effect of Albuterol ex-Vivo

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00162422
Other study ID # yc19557-HMO-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received September 11, 2005
Last updated October 28, 2008
Start date August 2003

Study information
Verified date October 2008
Source Hadassah Medical Organization
Contact Arik Tzukert, DMD
Phone 00 972 2 6776095
Email arik@hadassah.org.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Macroscopically normal pulmonary tissue

Exclusion Criteria:

- The presence of pathological finding in the pulmonary tissue

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• albuterol

Locations
Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary The extent of bronchial dilatation ex-vivo
Primary The extent of decrease in brochial dilatation after prolonged incubation with albuterol
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