NCT03990402

Brief Summary

The main aim of the study is to identify altogether 3000 children aged between 12 and 16 years old with asthma symptoms in six sub-Saharan African countries. The study furthermore aims to assess their asthma control, current treatment, knowledge of and attitudes to asthma, as well as the barriers to achieving good asthma control.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
3,767

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
6 countries

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

January 8, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

May 16, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

3.6 years

First QC Date

January 8, 2019

Last Update Submit

March 8, 2023

Conditions

Asthma

Keywords

FeNOAfricaSpirometryAsthma ControlACTPrevalence

Outcome Measures

Primary Outcomes (1)

  • Percentage of children with asthma symptoms or asthma

    Percentage of children with asthma or asthma symptoms, based on GAN (Global Asthma Network) screening tool.

    12 months

Secondary Outcomes (15)

  • Understanding about Asthma - Questions

    1 year

  • Brief Illness Perception Questionnaire

    1 year

  • Asthma control test

    4 weeks

  • environmental factor assessment

    1 year

  • access to medical care of young people with asthma

    1 year

  • +10 more secondary outcomes

Study Arms (6)

Malawi group

500 young people with asthma symptoms in Malawi

South Africa group

500 young people with asthma symptoms in South Africa

Uganda group

500 young people with asthma symptoms in Uganda

Nigeria

500 young people with asthma symptoms in Nigeria

Zimbabwe group

500 young people with asthma symptoms in Zimbabwe

Ghana group

500 young people with asthma symptoms in Ghana

Eligibility Criteria

Age12 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Young people between 12 and 14 years of age.

You may qualify if:

  • aged between a minimum of 12 years, and
  • a maximum of 14 years

You may not qualify if:

  • Age less than 12 years
  • age more than 14 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Kwame Nkrumah University of Science & Technology (KNUST)

Kumasi, Ashanti Region, 00000, Ghana

Location

Malawi-Liverpool-Wellcome Trust Clinical Research Programme

Blantyre, 3, Malawi

Location

Lagos State University College of Medicine

Lagos, 00000, Nigeria

Location

University of Kwa-Zulu Natal

Durban, KwaZulu-Natal, South Africa

Location

Makarere University College of Health Sciences

Kampala, 00000, Uganda

Location

University of Zimbabwe College of Health Sciences

Harare, MP167, Zimbabwe

Location

Related Publications (1)

  • Oyenuga VO, Mosler G, Addo-Yobo E, Adeyeye OO, Arhin B, Fortune F, Griffiths CJ, Kasekete M, Mkutumula E, Mphahlele R, Mujuru HA, Muyemayema S, Nantanda R, Nkhalamba LM, Ojo OT, Owusu SK, Ticklay I, Ubuane PO, Yakubu RC, Zurba L, Masekela R, Grigg J. Asthma symptoms, severity, and control with and without a clinical diagnosis of asthma in early adolescence in sub-Saharan Africa: a multi-country, school-based, cross-sectional study. Lancet Child Adolesc Health. 2024 Dec;8(12):859-871. doi: 10.1016/S2352-4642(24)00232-3. Epub 2024 Oct 21.

    PMID: 39447587DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jonathan Grigg, Professor

    Queen Mary University of London, Blizard Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Paediatric Respiratory and Environmental Medicine

Study Record Dates

First Submitted

January 8, 2019

First Posted

June 19, 2019

Study Start

May 16, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 10, 2023

Record last verified: 2023-03

Locations

NG(1)MA(1)ZA(1)UG(1)ZI(1)GH(1)