NCT00162396

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
Last Updated

October 29, 2008

Status Verified

October 1, 2008

First QC Date

September 11, 2005

Last Update Submit

October 28, 2008

Conditions

Asthma

Keywords

Albuterolβ2 Adrenergic receptorPolymorphism

Outcome Measures

Primary Outcomes (2)

  • Change in lung function tests after salbutamol inhalation

  • Change in blood pressure and pulse after salbutamol inhalation

Interventions

AlbuterolDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • Recently diagnosed as asthmatic

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Officials

  • Yoseph Caraco, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoseph Caraco, MD

CONTACT

00 972 2 6778584caraco@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 13, 2005

Study Start

August 1, 1999

Last Updated

October 29, 2008

Record last verified: 2008-10

Locations

IL(1)