Gene AbnormalitypolymorphismNCT03118869
B2 Adrenergic Receptor Gene Polymorphism in Bronchial Asthma
An observational study of Gene Abnormality and Asthma, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gene Abnormality, Asthma
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2017to 30 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed as asthma according to GINA 2016
Who may be able to join
- patients diagnosed as asthma according to GINA guideline 2016.
- Allergic asthma
Who cannot join
- pneumonia
- chronic cardiac, hepatic and renal diseases
- pregnancy and lactation
- malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: B2adrenergic Receptor Gene Polymorphism in Bronchial Asthma: Relation to Disease Severity and Control
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.
Read the 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.
- Conditions
- Gene Abnormality, Asthma
- Keywords
- Asthma, B2 adrenergic receptors, Polymorphism
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure number of patient with homozygous and heterozygous B2AD gene polymorphisms with focus on Arg/Gly16 and Gln/Glu27 polymorphism
study of prevalence homozygote and heterozygote patients
Measured: 1 month
Secondary outcomes (1)
Number of patient with b2AR gene polymorphisms in different asthma severity and different response of treatment of asthma ( Arg/Gly16 and Gln/Glu27 polymorphism)
correlation between polymorphism and pulmonary function test and level of disease control
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start1 Apr 2017
- Primary completion1 Oct 2017 (estimated)
- Study completion30 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gene AbnormalityStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliae AR Mohamed Hussein, Assiut University
- Investigators
- Aliae Mohamed-Hussein, Principal investigator, Professor of Pulmonology- Faculty of Medicine-Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118869
- Sponsor's protocol ID
- AssiutU3
- Acronym
- polymorphism
- Status last verified
- Aug 2017
- First submitted
- 11 Apr 2017
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30178312
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B2adrenergic Receptor Gene Polymorphism in Bronchial Asthma: Relation to Disease Severity and Control
- ClinicalTrials.gov ID
- NCT03118869
- Acronym / sponsor ID
- polymorphism / AssiutU3
- Conditions
- Gene Abnormality, Asthma
- Keywords
- Asthma, B2 adrenergic receptors, Polymorphism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Oct 2017 (estimated)
- Study completion
- 30 Oct 2017 (estimated)
- First posted
- 18 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed as asthma according to GINA 2016
Key inclusion criteria (2 listed)
- patients diagnosed as asthma according to GINA guideline 2016.
- Allergic asthma
Key exclusion criteria (4 listed)
- pneumonia
- chronic cardiac, hepatic and renal diseases
- pregnancy and lactation
- malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Derived from this study: PubMed 30178312Mohamed-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aliae Mohamed-Hussein principal investigator
Professor of Pulmonology- Faculty of Medicine-Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gene Abnormality and Asthma, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03118869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.