NCT01016444

Brief Summary

The hypothesis to be tested is that acutely ill asthmatics who do not resolve their attacks following standard doses of albuterol and require admission to hospital have single nucleotide polymorphisms of their B2 adrenergic receptors that lower B2 agonist responsivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
311

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2009

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2011

Completed
Last Updated

September 1, 2021

Status Verified

December 1, 2012

Enrollment Period

1.7 years

First QC Date

November 18, 2009

Last Update Submit

August 26, 2021

Conditions

Acute Asthma

Keywords

asthmaalbuterolB2AR receptorsAcute asthma responsive and unresponsive to albuterol

Outcome Measures

Primary Outcomes (1)

  • B2AR polymorphisms associated with albuterol responsiveness in acute asthma.

    ~ 1 hour following 3 doses of albuterol Q 20 min

Secondary Outcomes (1)

  • B2AR haplotypes

    ~ 1hr post 3 doses of albuterol

Study Arms (2)

Albuterol responsive

Those who respond clinically to albuterol.

Albuterol unresponsive

Albuterol non-responsiveness is defined as a failure of the PEFR in an acutely ill asthmatic to exceed 40% of predicted following ≥7.5 mg of albuterol (2.5 mg albuterol aerosols q.20 min x3).

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Asthmatic who presented to an Emergency Room with acute symptomatic airway obstruction who are treated with standard doses of albuterol and who either terminate their attacks rapidly or who are admitted to hospital for extensive treatment.

You may qualify if:

  • Acute asthma

You may not qualify if:

  • Any other condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA for analysis of B2AR polymorphysims, DNA for genes for inflamation,steroid and leukotriene responsiveness.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emergency Department physician

Study Record Dates

First Submitted

November 18, 2009

First Posted

November 19, 2009

Study Start

December 1, 2009

Primary Completion

July 29, 2011

Study Completion

July 29, 2011

Last Updated

September 1, 2021

Record last verified: 2012-12

Locations

US(1)