Genetic Determinants of the Bronchodilatation Effect of Albuterol ex-Vivo
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00162422|
Recruitment Status : Unknown
Verified October 2008 by Hadassah Medical Organization.
Recruitment status was: Recruiting
First Posted : September 13, 2005
Last Update Posted : October 29, 2008
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of β2 Genetic Polymorphisms on the Brochodilatation Effect of Albuterol ex-Vivo|
|Study Start Date :||August 2003|
- The extent of bronchial dilatation ex-vivo
- The extent of decrease in brochial dilatation after prolonged incubation with albuterol
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162422
|Contact: Arik Tzukert, DMD||00 972 2 firstname.lastname@example.org|
|Contact: Hadas Lemberg, PhD||00 972 2 email@example.com|
|Hadassah Medical Organization||Recruiting|
|Contact: Arik Tzukert, DMD 00 972 2 6776095 firstname.lastname@example.org|
|Contact: Hadas Lemberg, PhD 00 972 2 6777572 email@example.com|
|Principal Investigator: Yoseph Caraco, MD|
|Principal Investigator:||Yoseph Caraco, ND||Hadassah Medical Organization|