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Genetic Determinants of the Bronchodilatation Effect of Albuterol ex-Vivo

H

Hadassah Medical Center

Status

Unknown

Conditions

Asthma

Treatments

Drug: albuterol

Study type

Interventional

Funder types

Other

Identifiers

NCT00162422
yc19557-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Macroscopically normal pulmonary tissue

Exclusion criteria

  • The presence of pathological finding in the pulmonary tissue

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Hadas Lemberg, PhD; Arik Tzukert, DMD

Data sourced from clinicaltrials.gov

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