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...
Date First Received: September 11, 2005
Last Updated: March 17, 2008
Verified by: Hadassah Medical Organization, March 2008
Clinical Trial Phase: N/A | Start Date: August 1999
Overall Status: Recruiting
Estimated Enrollment: 150
Brief Summary
Official Title: “Evaluation of Genetic Factors That May Account for Variability in the Response to Salbutamol Among Patients Suffering From Asthma”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Intervention(s) in this Clinical Trial
- Drug: Albuterol
Outcome Measures for this Clinical Trial
Primary Measures
- Change in lung function tests after salbutamol inhalation
- Change in blood pressure and pulse after salbutamol inhalation
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Hadassah Medical Organization
Overall Clinical Trial Officials and Contacts
Yoseph Caraco, MD Principal Investigator Hadassah Medical Organization, Jerusalem, Israel
Overall Contact: Yoseph Caraco, MD 00 972 2 6778584 caraco@hadassah.org.il
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00162396
Study ID Number: yc195511-HMO-CTIL
ClinicalTrials.gov Identifier: NCT00162396
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration
Clinical Trials Authorship and Review
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