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
Recruitment status was Recruiting
Sponsor:
MetroHealth Medical Center
Collaborator:
GlaxoSmithKline
Information provided by:
MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT01016444
First received: November 18, 2009
Last updated: May 24, 2011
Last verified: November 2009
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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:
MedlinePlus related topics:
Asthma
Drug Information available for:
Albuterol
Levalbuterol
Levalbuterol hydrochloride
Albuterol sulfate
Levalbuterol tartrate
U.S. FDA Resources
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) |
| 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| Ages Eligible for Study: | 16 Years to 75 Years |
| 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.
Criteria
Inclusion Criteria:
- Acute asthma
Exclusion Criteria:
- Any other condition
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| 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 |
| Study First Received: | November 18, 2009 |
| Last Updated: | May 24, 2011 |
| Health Authority: | United States: Institutional Review Board |
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 Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 22, 2013