Prevalence of Asthma and Allergies Among Children in UAE (ISAAC-UAE)

July 16, 2020 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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)

Study Type

Observational

Enrollment (Actual)

3737

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Arab Emirates
      • 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, United Arab Emirates
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
13-14 years age group
Children with age 13-14 years at the time of questionnaires completion, and residing in Dubai and the Northern Emirates of UAE.
Other: Study questionnaires

Completion of the International study of Asthma and Allergies in Children(ISAAC)core questionnaires:

  1. Core questionnaire on wheezing.
  2. Core questionnaire on rhinitis.
  3. Core questionnaire on atopic dermatitis.
6-7 years age goup
Children with age 6-7 years at the time of questionnaires completion, and residing in Dubai and the Northern Emirates of UAE.
Other: Study questionnaires

Completion of the International study of Asthma and Allergies in Children(ISAAC)core questionnaires:

  1. Core questionnaire on wheezing.
  2. Core questionnaire on rhinitis.
  3. Core questionnaire on atopic dermatitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of asthma in children aged 6-7 years and 13-14 years in Dubai and the Northern Emirates.
Time Frame: 3 Month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of asthma in children aged 6-7 years and 13-14 years in Dubai and the Northern Emirates.
Time Frame: 3 Month

Through International study of Asthma and Allergies in Children(ISAAC)core questionnaire on (a)Wheezing,(b)rhinitis and (c)atopic dermatitis.

  1. Wheezing questionnaire:8 questions to address wheezing attacks, frequency, assessing prevalence illness, diagnosis of asthma.
  2. Rhinitis questionnaire : 6 questions to addressing detection of rhinitis, detecting atopy among subjects with rhinitis , interference with daily activities.

  3. 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
Time Frame: 3 Month
Questionnaire of Exposer to Arabian incense "Bokhor"
3 Month
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
Time Frame: 3 Month
Smoking questions of the environmental questionnaire
3 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 30, 2019

Primary Completion (ACTUAL)

June 26, 2019

Study Completion (ACTUAL)

June 26, 2019

Study Registration Dates

First Submitted

March 15, 2019

First Submitted That Met QC Criteria

March 15, 2019

First Posted (ACTUAL)

March 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 17, 2020

Last Update Submitted That Met QC Criteria

July 16, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2287R00142

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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