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Acute Asthma Responsiveness and B2 Adrenergic Receptors Polymorphisms

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. Identifier: NCT01016444
Recruitment Status : Unknown
Verified November 2009 by MetroHealth Medical Center.
Recruitment status was:  Recruiting
First Posted : November 19, 2009
Last Update Posted : May 25, 2011
Information provided by:
MetroHealth Medical Center

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.

Condition or disease
Acute Asthma

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Study Type : Observational
Estimated Enrollment : 1250 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: β2AR Polymorphisms and Albuterol Responsiveness in Acute Asthma
Study Start Date : December 2009
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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).

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

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
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.

Inclusion Criteria:

  • Acute asthma

Exclusion Criteria:

  • Any other condition

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 identifier (NCT number): NCT01016444

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Contact: Robynn Cox, RN 216-778-3227
Contact: Cynthia Newnan, RN 216-778-3227

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United States, Ohio
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Robynn Cox, RN    216-778-3227   
Contact: Cynthia Newman, RN    216-778-3237   
Principal Investigator: E. R. Mc Fadden, Jr, MD,         
Sponsors and Collaborators
MetroHealth Medical Center
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Responsible Party: E. R. Mc Fadden, Jr., MD, DSc, MetroHealth Medical Center, Case Western Reserve University School of Medicine Identifier: NCT01016444    
Other Study ID Numbers: ERM B2AR
First Posted: November 19, 2009    Key Record Dates
Last Update Posted: May 25, 2011
Last Verified: November 2009
Keywords provided by MetroHealth Medical Center:
B2AR receptors
Acute asthma responsive and unresponsive to albuterol
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases