AsthmaACACIANCT03990402
Achieving Control of Asthma in Children In Africa
An observational study of Asthma, run by Queen Mary University of London at 6 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 3,767 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 16 May 2019to 31 Dec 2022
- 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 12 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Young people between 12 and 14 years of age.
Who may be able to join
- aged between a minimum of 12 years, and
- a maximum of 14 years
Who cannot join
- Age less than 12 years
- age more than 14 years
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
Ghana1 site
Kwame Nkrumah University of Science & Technology (KNUST)
Kumasi, Ashanti Region, 00000
Malawi1 site
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Blantyre, 3
Zimbabwe1 site
University of Zimbabwe College of Health Sciences
Harare, MP167
About this study
Official title: GHR (Global Health Research) Project:17/63/38 - NIHR (National Institute for Health Research) Global Health Research Group on Improving Asthma Outcomes in African Children at Queen Mary University of London
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.
Read the detailed description
Asthma prevalence in young people has been rising in several African countries during the last decade, reaching between 10% and 20% in Central Africa, and up to 20% in South Africa. In addition, asthma related mortality in many African countries is high. South Africa has the third highest asthma related mortality rate in the world. Yet to date, a lack of asthma research and research infrastructure means that we do not have the evidence to either inform advocacy or to develop interventions that improve asthma outcomes.
This study aims to collect data about asthma prevalence and to identify existing barriers to effective asthma management of young people in 6 sub-Saharan countries: Malawi, South Africa, Zimbabwe, Uganda, Ghana, and Nigeria. Each of these countries identifies 500 young people with asthma between 12 and 16 years of age through a screening questionnaire in schools. These 3000 young people with asthma symptoms fill in a survey about asthma, including questions around asthma control, current treatment and access to care, asthma knowledge, asthma attitudes, smoking and environmental influences. Some of the participants also discuss asthma related topics in focus groups. A subset of the participants furthermore do Spirometry and FeNO testing. In addition to the data collection, the study develops and tests options for an intervention aimed at improving asthma control, including the adaption of a United Kingdom - based theater play about asthma awareness. The development of WiFi infrastructure and IT solutions is promoted by the study, where appropriate.
- Conditions
- Asthma
- Keywords
- FeNO, Africa, Spirometry, Asthma Control, ACT, Prevalence
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of children with asthma symptoms or asthma
Percentage of children with asthma or asthma symptoms, based on GAN (Global Asthma Network) screening tool.
Measured: 12 months
Secondary outcomes (15)
Understanding about Asthma - Questions
set of questions about asthma knowledge, maximum knowledge score is 13, minimum knowledge score is 0, total range is 13. Higher values represent better knowledge.
Measured: 1 year
Brief Illness Perception Questionnaire
Each of the 9 items in the Brief Illness Perception Questionnaire has a minimum score of 0 and a maximum score of 10.
The consequences score is the response to item 1. The timeline score is the response to item 2. The personal control scores is the response to item 3. The treatment control score is the response to item 4. The identity score is the response to item 5. The coherence score is the response to item 7. The emotional representation is the response to item 8. Illness concern is measured by item 6. Item 9 is the causal item.
Overall score which represents the degree to which the illness is perceived as threatening or benign. To compute that score, reverse score items 3, 4, and 7 and add these to items 1, 2, 5, 6, and 8. A higher score reflects a more threatening view of the illness. The overall score has a minimum score of 0 and a maximum score is 80.
Measured: 1 year
Asthma control test
using validated ACT - Asthma Control Test (license by GlaxoSmithKlyne). The minimum score is 5 (poor control of asthma), the maximum score is 25 (complete control of asthma). An ACT score >19 indicates well-controlled asthma
Measured: 4 weeks
environmental factor assessment
questions related to the environment of young people with asthma symptoms, reported using descriptive statistics, and percentages
Measured: 1 year
access to medical care of young people with asthma
set of questions related to access to medical care, reported using descriptive statistics, and percentages
Measured: 1 year
current treatment of asthma
set of questions about current medication, reported using descriptive statistics, and percentages
Measured: 1 year
Adherence to medication
set of questions asking about adherence to medication, reported as descriptive statistics and percentages, as well as free text comments.
Measured: 1 year
asthma-related time off school
questions asking about asthma-related time off school, reported as descriptive statistics and percentages
Measured: 4 weeks
smoking
questions assessing active and passive smoking, reported as descriptive statistics and percentages
Measured: 1 year
FeNO (fractional exhaled nitric oxide)
FeNO measurements - exhaled Nitric Oxide
Measured: up to 1 day
Spirometry FEV1
FEV1, in liter, and in liter predicted
Measured: up to 1 day
Asthma Control according to GINA (Global INitiative for Asthma)
GINA questionnaire (Global INitiative for Asthma) using four questions, assessing control of asthma symptoms. Outcome is 'well controlled' if none of the four questions is answered 'Yes', 'partly controlled' if one or two of the four questions is answered 'Yes', uncontrolled, if three or four of the four questions is answered 'Yes'.
Measured: 4 weeks
Spirometry FVC
FVC, in liter, and in liter predicted
Measured: up to 1 day
Spirometry FEV1/FVC
Ratio of FEV1 to FVC
Measured: up to 1 day
FEF25-75
FEF25-75 as percentage
Measured: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start16 May 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 3,767 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Principal investigator, Jonathan Grigg, Queen Mary University of London
- Investigators
- Jonathan Grigg, Professor, Principal investigator, Queen Mary University of London, Blizard Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03990402
- Sponsor's protocol ID
- 269211
- Acronym
- ACACIA
- Status last verified
- Mar 2023
- First submitted
- 8 Jan 2019
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are currently working on a detailed plan to share the collected data with other researchers in accordance with the existing data protection legislation.
Publications
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.
PubMed 39447587
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GHR (Global Health Research) Project:17/63/38 - NIHR (National Institute for Health Research) Global Health Research Group on Improving Asthma Outcomes in African Children at Queen Mary University of London
- ClinicalTrials.gov ID
- NCT03990402
- Acronym / sponsor ID
- ACACIA / 269211
- Conditions
- Asthma
- Keywords
- FeNO, Africa, Spirometry, Asthma Control, ACT, Prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,767 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 16 May 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Jun 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.
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.
Detailed description
Asthma prevalence in young people has been rising in several African countries during the last decade, reaching between 10% and 20% in Central Africa, and up to 20% in South Africa. In addition, asthma related mortality in many African countries is high. South Africa has the third highest asthma related mortality rate in the world. Yet to date, a lack of asthma research and research infrastructure means that we do not have the evidence to either inform advocacy or to develop interventions that improve asthma outcomes.
This study aims to collect data about asthma prevalence and to identify existing barriers to effective asthma management of young people in 6 sub-Saharan countries: Malawi, South Africa, Zimbabwe, Uganda, Ghana, and Nigeria. Each of these countries identifies 500 young people with asthma between 12 and 16 years of age through a screening questionnaire in schools. These 3000 young people with asthma symptoms fill in a survey about asthma, including questions around asthma control, current treatment and access to care, asthma knowledge, asthma attitudes, smoking and environmental influences. Some of the participants also discuss asthma related topics in focus groups. A subset of the participants furthermore do Spirometry and FeNO testing. In addition to the data collection, the study develops and tests options for an intervention aimed at improving asthma control, including the adaption of a United Kingdom - based theater play about asthma awareness. The development of WiFi infrastructure and IT solutions is promoted by the study, where appropriate.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Young people between 12 and 14 years of age.
Key inclusion criteria (2 listed)
- aged between a minimum of 12 years, and
- a maximum of 14 years
Key exclusion criteria (2 listed)
- Age less than 12 years
- age more than 14 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of children with asthma symptoms or asthma
Time frame: 12 months
Percentage of children with asthma or asthma symptoms, based on GAN (Global Asthma Network) screening tool.
15 secondary outcomes
Understanding about Asthma - Questions
Time frame: 1 year
Brief Illness Perception Questionnaire
Time frame: 1 year
Asthma control test
Time frame: 4 weeks
environmental factor assessment
Time frame: 1 year
access to medical care of young people with asthma
Time frame: 1 year
current treatment of asthma
Time frame: 1 year
Adherence to medication
Time frame: 1 year
asthma-related time off school
Time frame: 4 weeks
smoking
Time frame: 1 year
FeNO (fractional exhaled nitric oxide)
Time frame: up to 1 day
Spirometry FEV1
Time frame: up to 1 day
Asthma Control according to GINA (Global INitiative for Asthma)
Time frame: 4 weeks
Spirometry FVC
Time frame: up to 1 day
Spirometry FEV1/FVC
Time frame: up to 1 day
FEF25-75
Time frame: up to 1 day
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 10 Mar 2023.
- Derived from this study: PubMed 39447587Oyenuga 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.
- Individual participant dataSharing planned: Undecided. We are currently working on a detailed plan to share the collected data with other researchers in accordance with the existing data protection legislation.
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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.
Jonathan Grigg, Professor principal investigator
Queen Mary University of London, Blizard Institute
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Queen Mary University of London at 6 sites in 6 countries.
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 2 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 10 Mar 2023. 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 Ghana, Malawi, Nigeria, South Africa, Uganda and 1 more country. 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?
Percentage of children with asthma symptoms or asthma (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03990402, which also lists 1 linked publication.
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 10 Mar 2023.