Genetic Determinants of the Response to Salbutamol Among Asthma Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

September 11, 2005

Last Updated Date

October 28, 2008

Start Date ^ICMJE

August 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change in lung function tests after salbutamol inhalation
Change in blood pressure and pulse after salbutamol inhalation

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00162396 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Genetic Determinants of the Response to Salbutamol Among Asthma Patients

Official Title ^ICMJE

Evaluation of Genetic Factors That May Account for Variability in the Response to Salbutamol Among Patients Suffering From Asthma

Brief Summary

The response to salbutamol varies greatly among individuals. Data from previous studies indicate that some of the variability is accounted for by genetic polymorphisms in the gene encoding for the adrenoceptor subtype β2. The current study was designed to evaluate variability in the response to salbutamol among recently diagnosed patients who have not been treated by β2 agonists or corticosteroids.

Lung function tests will be performed prior to and following a single dose administration of salbutamol through inhalation. Additional pharmacodynamic indices will be monitored including pulse and blood pressure. Three samples of plasma will be drawn for the evaluation of salbutamol plasma concentration.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: Albuterol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

18 years and older
Recently diagnosed as asthmatic

Exclusion Criteria:

Current treatment by β2 agonist
Current treatment by corticosteroids
Acute asthma attack

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Yoseph Caraco, MD

00 972 2 6778584

caraco@hadassah.org.il

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00162396

Responsible Party

Study ID Numbers ^ICMJE

yc195511-HMO-CTIL

Study Sponsor ^ICMJE

Hadassah Medical Organization

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Yoseph Caraco, MD

Hadassah Medical Organization, Jerusalem, Israel

Information Provided By

Hadassah Medical Organization

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP