Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Acute Asthma Responsiveness and B2 Adrenergic Receptors Polymorphisms

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by MetroHealth Medical Center.
Recruitment status was  Recruiting
Information provided by:
MetroHealth Medical Center Identifier:
First received: November 18, 2009
Last updated: May 24, 2011
Last verified: November 2009
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.

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • B2AR haplotypes [ Time Frame: ~ 1hr post 3 doses of albuterol ] [ Designated as safety issue: No ]

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)
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


Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01016444

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

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
  More Information

Responsible Party: E. R. Mc Fadden, Jr., MD, DSc, MetroHealth Medical Center, Case Western Reserve University School of Medicine Identifier: NCT01016444     History of Changes
Other Study ID Numbers: ERM B2AR 
Study First Received: November 18, 2009
Last Updated: May 24, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
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 processed this record on October 21, 2016