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NCT Number: NCT03878680

Prevalence of Asthma and Allergies Among Children in UAE

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Ajman, United Arab Emirates

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About this 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.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

  • Core questionnaire on wheezing.
  • Core questionnaire on rhinitis.
  • Core questionnaire on atopic dermatitis.
  • Smoking questions of the environmental questionnaire.
  • Video questionnaire on wheezing (only for 13-14 years age group, if applicable)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Study questionnaires

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

    • 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.

Other outcomes

  1. 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"

  2. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: ISAAC-UAE

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 18, 2019
Registry last updated
Jul 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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