B2 Adrenergic Receptor Gene Polymorphism in Bronchial Asthma (polymorphism)

• ClinicalTrials.gov Identifier: NCT03118869
• Recruitment Status: Unknown
• First Posted: April 18, 2017
• Last Update Posted: August 28, 2017
• Sponsor: Assiut University
• Information provided by (Responsible Party): Aliae AR Mohamed Hussein, Assiut University

Tracking Information

• First Submitted Date: April 11, 2017
• First Posted Date: April 18, 2017
• Last Update Posted Date: August 28, 2017
• Actual Study Start Date: April 1, 2017
• Estimated Primary Completion Date: October 1, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 13, 2017)

To measure number of patient with homozygous and heterozygous B2AD gene polymorphisms with focus on Arg/Gly16 and Gln/Glu27 polymorphism [ Time Frame: 1 month ]

study of prevalence homozygote and heterozygote patients

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 13, 2017)

Number of patient with b2AR gene polymorphisms in different asthma severity and different response of treatment of asthma ( Arg/Gly16 and Gln/Glu27 polymorphism) [ Time Frame: 1 month ]

correlation between polymorphism and pulmonary function test and level of disease control

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: B2 Adrenergic Receptor Gene Polymorphism in Bronchial Asthma
• Official Title: B2adrenergic Receptor Gene Polymorphism in Bronchial Asthma: Relation to Disease Severity and Control

Brief Summary

The b2-adrenoceptor (b2AR) mediates the physiological responses in the airway, which include bronchodilation, bronchoprotection. The b2-adrenoceptor (b2AR) mediates the physiological responses in the airway, which include bronchodilation, bronchoprotection, Enhanced mucociliary clearance.

The b2AR gene is located on chromosome 5q31-q32, a region that is genetically linked to asthma and related phenotypes. There are three best known polymorphisms in the coding region of the b2AR gene that can modulate the function of the receptor.

Detailed Description

Asthma is a complex disease and has a strong genetic component in its pathogenesis. So far, considerable efforts have been made to evaluate the association between genetic variants and asthma risk, and numerous genes have been identified as asthma Reporting Items susceptible genes.

The b2-adrenoceptor (b2AR) mediates the physiological responses in the airway, which include bronchodilation, bronchoprotection. The b2-adrenoceptor (b2AR) mediates the physiological responses in the airway, which include bronchodilation, bronchoprotection, Enhanced mucociliary clearance.

The b2AR gene is located on chromosome 5q31-q32, a region that is genetically linked to asthma and related phenotypes. There are three best known polymorphisms in the coding region of the b2AR gene that can modulate the function of the receptor.

• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Patients diagnosed as asthma according to GINA 2016

Condition

• Gene Abnormality
• Asthma

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Mohamed-Hussein AAR, Sayed SS, Eldien HMS, Assar AM, Yehia FE. Beta 2 Adrenergic Receptor Genetic Polymorphisms in Bronchial Asthma: Relationship to Disease Risk, Severity, and Treatment Response. Lung. 2018 Dec;196(6):673-680. doi: 10.1007/s00408-018-0153-3. Epub 2018 Sep 3.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: April 13, 2017): 75
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 30, 2017
• Estimated Primary Completion Date: October 1, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• patients diagnosed as asthma according to GINA guideline 2016.
• Allergic asthma

Exclusion Criteria:

• pneumonia
• chronic cardiac, hepatic and renal diseases
• pregnancy and lactation
• malignancy

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT03118869
• Other Study ID Numbers: AssiutU3
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Aliae AR Mohamed Hussein, Assiut University
• Study Sponsor: Assiut University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Aliae Mohamed-Hussein; Professor of Pulmonology- Faculty of Medicine-Assiut University

• PRS Account: Assiut University
• Verification Date: August 2017