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NCT00162396 Clinical Trial

Genetic Determinants of the Response to Salbutamol Among Asthma Patients

Asthma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00162396
Other study ID # yc195511-HMO-CTIL
Secondary ID
Status Recruiting
Phase N/A
First received September 11, 2005
Last updated October 28, 2008
Start date August 1999

Study information
Verified date October 2008
Source Hadassah Medical Organization
Contact Yoseph Caraco, MD
Phone 00 972 2 6778584
Email caraco@hadassah.org.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years and older

- Recently diagnosed as asthmatic

Exclusion Criteria:

- Current treatment by ß2 agonist

- Current treatment by corticosteroids

- Acute asthma attack

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• Albuterol

Locations
Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in lung function tests after salbutamol inhalation
Primary Change in blood pressure and pulse after salbutamol inhalation
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