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Trial record 98 of 154 for:    Dermatitis, Atopic, 8

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

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ClinicalTrials.gov Identifier: NCT03878680
Recruitment Status : Recruiting
First Posted : March 18, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief 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.

Condition or disease Intervention/treatment
Asthma Other: Study questionnaires

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)

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Study Type : Observational
Estimated Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Asthma and Allergies Among Children in UAE-A Cross-sectional Study
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : November 15, 2019
Estimated Study Completion Date : November 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Asthma

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.

    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.


Other Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878680


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 ext 190 information.center@astrazeneca.com

Locations
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United Arab Emirates
Research Site Recruiting
Ajman, United Arab Emirates
Research Site Recruiting
Dubai, United Arab Emirates
Research Site Not yet recruiting
Dubai, United Arab Emirates
Research Site Recruiting
FUJ, United Arab Emirates
Research Site Not yet recruiting
FUJ, United Arab Emirates
Research Site Not yet recruiting
RAK, United Arab Emirates
Research Site Recruiting
Sharjah, United Arab Emirates
Research Site Not yet recruiting
Sharjah, United Arab Emirates
Research Site Not yet recruiting
UMQ, United Arab Emirates
Research Site Recruiting
UMQ, United Arab Emirates
Sponsors and Collaborators
AstraZeneca

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03878680     History of Changes
Other Study ID Numbers: D2287R00142
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases