Genetic Determinants of the Bronchodilatation Effect of Albuterol ex-Vivo

NCT ID: NCT00162422

Last Updated: 2008-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

albuterol

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Macroscopically normal pulmonary tissue

Exclusion Criteria

* The presence of pathological finding in the pulmonary tissue
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hadassah Medical Organization

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yoseph Caraco, ND

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hadassah Medical Organization

Jerusalem, , Israel

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Arik Tzukert, DMD

Role: CONTACT

Phone: 00 972 2 6776095

Email: [email protected]

Hadas Lemberg, PhD

Role: CONTACT

Phone: 00 972 2 6777572

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Arik Tzukert, DMD

Role: primary

Hadas Lemberg, PhD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

yc19557-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id