NCT03878680

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,737

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 30, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2019

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

March 15, 2019

Last Update Submit

July 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Severity of asthma in children aged 6-7 years and 13-14 years in Dubai and the Northern Emirates.

    3 Month

Other Outcomes (2)

  • 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".

    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

    3 Month

Study Arms (2)

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

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

Interventions

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.

13-14 years age group6-7 years age goup

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Research Site

Ajman, United Arab Emirates

Location

Research Site

Dubai, United Arab Emirates

Location

Research Site

FUJ, United Arab Emirates

Location

Research Site

Ras al-Khaimah, United Arab Emirates

Location

Research Site

Sharjah city, United Arab Emirates

Location

Research Site

UMQ, United Arab Emirates

Location

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2019

First Posted

March 18, 2019

Study Start

April 30, 2019

Primary Completion

June 26, 2019

Study Completion

June 26, 2019

Last Updated

July 17, 2020

Record last verified: 2020-07

Locations