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Acute Asthma Responsiveness and B2 Adrenergic Receptors Polymorphisms

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by MetroHealth Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01016444
First Posted: November 19, 2009
Last Update Posted: May 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by:
MetroHealth Medical Center
  Purpose
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.

Condition
Acute Asthma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: β2AR Polymorphisms and Albuterol Responsiveness in Acute Asthma

Resource links provided by NLM:


Further study details as provided by MetroHealth Medical Center:

Primary Outcome Measures:
  • B2AR polymorphisms associated with albuterol responsiveness in acute asthma. [ Time Frame: ~ 1 hour following 3 doses of albuterol Q 20 min ]

Secondary Outcome Measures:
  • B2AR haplotypes [ Time Frame: ~ 1hr post 3 doses of albuterol ]

Biospecimen Retention:   Samples With DNA
DNA for analysis of B2AR polymorphysims, DNA for genes for inflamation,steroid and leukotriene responsiveness.

Estimated Enrollment: 1250
Study Start Date: December 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • Acute asthma

Exclusion Criteria:

  • Any other condition
  Contacts and Locations
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): NCT01016444


Contacts
Contact: Robynn Cox, RN 216-778-3227 rcox1@metrohealth.org
Contact: Cynthia Newnan, RN 216-778-3227 cnewman@metrohealth.org

Locations
United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Robynn Cox, RN    216-778-3227    rcox1@merohealth.org   
Contact: Cynthia Newman, RN    216-778-3237    cnewman@metrohealth.org   
Principal Investigator: E. R. Mc Fadden, Jr, MD,         
Sponsors and Collaborators
MetroHealth Medical Center
GlaxoSmithKline
  More Information

Responsible Party: E. R. Mc Fadden, Jr., MD, DSc, MetroHealth Medical Center, Case Western Reserve University School of Medicine
ClinicalTrials.gov Identifier: NCT01016444     History of Changes
Other Study ID Numbers: ERM B2AR
First Submitted: November 18, 2009
First Posted: November 19, 2009
Last Update Posted: May 25, 2011
Last Verified: November 2009

Keywords provided by MetroHealth Medical Center:
asthma
albuterol
B2AR receptors
Acute asthma responsive and unresponsive to albuterol

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


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