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Genetic Determinants of the Bronchodilatation Effect of Albuterol ex-Vivo

Information source: Hadassah Medical Organization
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: albuterol (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Hadassah Medical Organization

Official(s) and/or principal investigator(s):
Yoseph Caraco, ND, Principal Investigator, Affiliation: Hadassah Medical Organization

Overall contact:
Arik Tzukert, DMD, Phone: 00 972 2 6776095, Email: arik@hadassah.org.il

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.

Clinical Details

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study

Primary outcome:

The extent of bronchial dilatation ex-vivo

The extent of decrease in brochial dilatation after prolonged incubation with albuterol

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Macroscopically normal pulmonary tissue

Exclusion Criteria:

- The presence of pathological finding in the pulmonary tissue

Locations and Contacts

Arik Tzukert, DMD, Phone: 00 972 2 6776095, Email: arik@hadassah.org.il

Hadassah Medical Organization, Jerusalem, Israel; Recruiting
Arik Tzukert, DMD, Phone: 00 972 2 6776095, Email: arik@hadassah.org.il
Hadas Lemberg, PhD, Phone: 00 972 2 6777572, Email: lhadas@hadassah.org.il
Yoseph Caraco, MD, Principal Investigator
Additional Information

Starting date: August 2003
Last updated: October 28, 2008

Page last updated: October 19, 2009

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