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Genetic Determinants of the Bronchodilatation Effect of Albuterol ex-Vivo

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
Information provided by:
Hadassah Medical Organization Identifier:
First received: September 11, 2005
Last updated: October 28, 2008
Last verified: October 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 Intervention
Asthma Drug: albuterol

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • The extent of bronchial dilatation ex-vivo
  • The extent of decrease in brochial dilatation after prolonged incubation with albuterol

Estimated Enrollment: 150
Study Start Date: August 2003

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00162422

Contact: Arik Tzukert, DMD 00 972 2 6776095
Contact: Hadas Lemberg, PhD 00 972 2 6777572

Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095   
Contact: Hadas Lemberg, PhD    00 972 2 6777572   
Principal Investigator: Yoseph Caraco, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Yoseph Caraco, ND Hadassah Medical Organization
  More Information Identifier: NCT00162422     History of Changes
Other Study ID Numbers: yc19557-HMO-CTIL
Study First Received: September 11, 2005
Last Updated: October 28, 2008

Additional relevant MeSH terms:
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017