Genetic Determinants of the Bronchodilatation Effect of Albuterol ex-Vivo

The recruitment status of this study is unknown because the information has not been verified recently.
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
Drug: albuterol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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
Genders Eligible for Study:   Both
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

No publications provided Identifier: NCT00162422     History of Changes
Other Study ID Numbers: yc19557-HMO-CTIL
Study First Received: September 11, 2005
Last Updated: October 28, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents processed this record on November 24, 2015