Prevalence of Asthma and Allergies Among Children in UAE

Asthma Clinical Trial

— ISAAC-UAE  

Official title:

Prevalence of Asthma and Allergies Among Children in UAE-A Cross-sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03878680
• Other study ID #: D2287R00142
• Status: Completed
• Start date: April 30, 2019
• Est. completion date: June 26, 2019

Study information

• Verified date: July 2020
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Multicenter, cross-sectional study to recruit a random sample of 6000 children via school class registers: 3000 children aged 13-14 years and 3000 children aged 6-7 years.

Description:

Multicenter, cross-sectional study to recruit a random sample of 6000 children via school class registers: 3000 children aged 13-14 years and 3000 children aged 6-7 years.Standard ISAAC core questions for wheezing, rhinitis, and atopic dermatitis will be used. The ISAAC questionnaire has been validated by the World Health Organization and translated into many languages, and used in many countries. In this study, the Arabic and English version will be used. In addition, questions regarding exposure to Arabian incense "Bokhor" and smoking questions of the environmental questionnaire will be included.

ISAAC Questionnaires

1. Core questionnaire on wheezing.

2. Core questionnaire on rhinitis.

3. Core questionnaire on atopic dermatitis.

4. Smoking questions of the environmental questionnaire.

5. Video questionnaire on wheezing (only for 13-14 years age group, if applicable)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3737
• Est. completion date: June 26, 2019
• Est. primary completion date: June 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Children with age 6 to 7 years or with age 13 to 14 years at the time of questionnaires completion, and residing in Dubai and the Northern Emirates of UAE.

• Children aged 6 to 7 years or 13 to14 years, whose legal guardians give their consent.

• Able to give assent in the 13 to 14 years group.

• Able to comprehend and answer the questionnaire themselves in the 13 to 14 years group.

Exclusion Criteria:

• Aged 13 to 14 years and unable to answer the questionnaire due to physical or mental disability.

• Parent or legal guardian refuses sign and return consent for the 6 to 7 years group and the 13 to 14 years group.

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Study questionnaires
Completion of the International study of Asthma and Allergies in Children(ISAAC)core questionnaires: Core questionnaire on wheezing. Core questionnaire on rhinitis. Core questionnaire on atopic dermatitis.

Locations

Country	Name	City	State
United Arab Emirates	Research Site	Ajman
United Arab Emirates	Research Site	Dubai
United Arab Emirates	Research Site	FUJ
United Arab Emirates	Research Site	RAK
United Arab Emirates	Research Site	Sharjah
United Arab Emirates	Research Site	UMQ

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prevalence of asthma in children aged 6-7 years and 13-14 years in Dubai and the Northern Emirates, who were exposed to Arabian incense "Bokhor".	Questionnaire of Exposer to Arabian incense "Bokhor"	3 Month
Other	Prevalence of asthma in children aged 6-7 years and 13-14 years in Dubai and the Northern Emirates, who were exposed to tobacco smoke	Smoking questions of the environmental questionnaire	3 Month
Primary	Prevalence of asthma in children aged 6-7 years and 13-14 years in Dubai and the Northern Emirates.	Through International study of Asthma and Allergies in Children(ISAAC)core questionnaire on Asthma and Wheezing: A set of 8 questions to address wheezing attacks, assessing the prevalence of wheezing illness, frequency of wheezing, diagnosis of asthma.Descriptive summaries of the data will be presented. Comparisons between different centers on the rates of events will be made using appropriate methods. Crude rates can be compared by using contingency tables or logistic regression. Comparison of standardized rates or data that needs controlling for confounding will require analysis by logistic regression	3 Month
Secondary	Severity of asthma in children aged 6-7 years and 13-14 years in Dubai and the Northern Emirates.	Through International study of Asthma and Allergies in Children(ISAAC)core questionnaire on (a)Wheezing,(b)rhinitis and (c)atopic dermatitis.; Wheezing questionnaire:8 questions to address wheezing attacks, frequency, assessing prevalence illness, diagnosis of asthma.; Rhinitis questionnaire : 6 questions to addressing detection of rhinitis, detecting atopy among subjects with rhinitis , interference with daily activities.; Atopic Dermatitis questionnaire : 7 questions to addressing severity, rashes, and nonatopic forms of eczema.; Most of the questions used iare Binary questions Yes or NO .; Data from 6-7 year old and 13-14 year old analysis separately. Each measure of prevalence and severity will be compared between centres. The effect of cluster sampling by schools will considered in the analysis.; Basic descriptive summaries data will be compiled and presented for each condition, in both age groups, for males and females, from each centres.	3 Month

External Links

•   CSR Synopsis