AsthmaISAAC-UAENCT03878680
Prevalence of Asthma and Allergies Among Children in UAE
An observational study of Asthma, run by AstraZeneca at 6 sites in United Arab Emirates.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- What is being tested?
- Study questionnaires
- How many people
- 3,737 participants
- Where
- 6 sitesUnited Arab Emirates
- Study dates
- 30 Apr 2019to 26 Jun 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Arab Emirates6 sites
Research Site
Ajman
Research Site
Dubai
Research Site
FUJ
Research Site
Ras al-Khaimah
Research Site
Sharjah city
Research Site
UMQ
About this study
Official title: 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.
Read the 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
- 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)
- Conditions
- Asthma
- Being tested
- Study questionnaires
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study questionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Study questionnaires | |
| 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. Receives: Other: Study questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 Month
Secondary outcomes (1)
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.
Measured: 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start30 Apr 2019
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,737 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878680
- Sponsor's protocol ID
- D2287R00142
- Acronym
- ISAAC-UAE
- Status last verified
- Jul 2020
- First submitted
- 15 Mar 2019
- Last updated
- 17 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Asthma and Allergies Among Children in UAE-A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03878680
- Acronym / sponsor ID
- ISAAC-UAE / D2287R00142
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,737 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 18 Mar 2019 (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.
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.
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
- 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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 13-14 years age group | – | Other: Study questionnairesChildren with age 13-14 years at the time of questionnaires completion, and residing in Dubai and the Northern Emirates of UAE. |
| 6-7 years age goup | – | Other: Study questionnairesChildren with age 6-7 years at the time of questionnaires completion, and residing in Dubai and the Northern Emirates of UAE. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study questionnairesCompletion 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. | Other | 13-14 years age group, 6-7 years age goup |
Primary outcome
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
1 secondary outcome
Severity of asthma in children aged 6-7 years and 13-14 years in Dubai and the Northern Emirates.
Time frame: 3 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- CSR SynopsisLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca at 6 sites in United Arab Emirates.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Arab Emirates. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of asthma in children aged 6-7 years and 13-14 years in Dubai and the Northern Emirates. (time frame: 3 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2020.