Genetic Determinants of the Response to Salbutamol Among... | NCT00162396

Studies
Genetic Determinants of the Response to Salbutamol Among Asthma Patients

NCT00162396

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Oct 29, 2008Estimated

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Asthma

Interventions

Albuterol

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1999

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 11, 2005

First Submission Date that Met QC Criteria

Sep 11, 2005

First Posted Date

Sep 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2008

Last Update Posted Date

Oct 29, 2008Estimated

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Name	Type	Description	Arm Group Labels	Other Names
Albuterol	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in lung function tests after salbutamol inhalation
Change in blood pressure and pulse after salbutamol inhalation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yoseph Caraco, MD	Contact	00 972 2 6778584		caraco@hadassah.org.il

Overall Officials

Name	Affiliation	Role
Yoseph Caraco, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization	Recruiting	Jerusalem		91120	Israel

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000420	Albuterol

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided