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Genetic Determinants of the Response to Salbutamol Among Asthma Patients

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ClinicalTrials.gov Identifier: NCT00162396
Recruitment Status : Unknown
Verified October 2008 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : September 13, 2005
Last Update Posted : October 29, 2008
Sponsor:
Information provided by:
Hadassah Medical Organization

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.


Condition or disease Intervention/treatment Phase
Asthma Drug: Albuterol Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of Genetic Factors That May Account for Variability in the Response to Salbutamol Among Patients Suffering From Asthma
Study Start Date : August 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources




Primary Outcome Measures :
  1. Change in lung function tests after salbutamol inhalation
  2. Change in blood pressure and pulse after salbutamol inhalation


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years and older
  • Recently diagnosed as asthmatic

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162396


Contacts
Contact: Yoseph Caraco, MD 00 972 2 6778584 caraco@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD    : 00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Yoseph Caraco, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Yoseph Caraco, MD Hadassah Medical Organization

ClinicalTrials.gov Identifier: NCT00162396     History of Changes
Other Study ID Numbers: yc195511-HMO-CTIL
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: October 29, 2008
Last Verified: October 2008

Keywords provided by Hadassah Medical Organization:
Albuterol
β2 Adrenergic receptor
Polymorphism

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action