Pan African Clinical Trials Registry

South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: www.pactr.org
Trial no.: PACTR201807211617031 Date of Approval: 09/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A randomised controlled trial of an enhanced asthma care package vs standard outpatient care on asthma control in Malawian children.
Official scientific title A randomised controlled trial of an enhanced asthma care package vs standard outpatient care on asthma control in Malawian children.
Brief summary describing the background and objectives of the trial - The type of research study This is a pilot randomised controlled trial of standard vs enhanced asthma care, involving children attending outpatient follow-up at Queen Elizabeth Central Hospital (QECH), Blantyre. - Background Asthma is the most common chronic medical condition in childhood and is an emerging problem in Africa. Chronic inflammation of the airways leads to typical symptoms of wheeze, cough and breathlessness which cause considerable morbidity if untreated. Malawi Standard Treatment Guidelines (2015) for asthma include inhaled short acting β2-agonist (SABA) and corticosteroid (ICS), although reliable supply and affordability is an issue. In an overburdened and understaffed clinical setting, key aspects of treatment; medication adjustment in response to disease control, and education of patients and their families, are often overlooked. Treatment guidelines, extrapolated from high-income settings, may not be appropriate in low-income countries (LIC) where different environmental exposures may drive the inflammatory process. Asthma is a heterogenous condition, with different airway inflammatory patterns (phenotypes), requiring alternative treatment approaches. However, the nature of airway inflammation in asthmatic children from LIC has not been described, and it is unclear whether good control of asthma symptoms can be achieved in children in Malawi, using inhaled corticosteroids. - The objectives This study will address the following questions; Can asthma control be improved through an enhanced care package, as compared to standard care in the paediatric clinic at QECH? What factors explain poor asthma control in included children? To what extent are indicators of eosinophilic airway inflammation associated with asthma control at baseline, and response to treatment?
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PAC
Disease(s) or condition(s) being studied Paediatrics,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/08/2018
Actual trial start date 12/09/2018
Anticipated date of last follow up 14/08/2019
Actual Last follow-up date 20/03/2020
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Completed
Publication URL https://doi.org/10.1101/2020.08.12.20173401
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard care n/a 3 months Children will receive standard care in the general paediatric clinic at QECH. SABA (eg. salbutamol) and corticosteroid (eg. beclomethasone diproprionate (HFA-BDP)) inhalers are included in the Malawi Standard Treatment Guidelines, and usually available, free of charge, in the hospital pharmacy. Dose adjustment of inhaled treatment, patient education and follow-up interval are at the discretion of the reviewing clinician (a Paediatric registrar or Consultant). 60 Active-Treatment of Control Group
Experimental Group Enhanced care n/a 3 months Families will receive an individual asthma education session from a specifically trained fieldworker (non-medical). Following a detailed clinical assessment, ICS treatment will be escalated in those children defined as having poor asthma control (cACT score ≤19), in line with global asthma guidelines. This subgroup of patients will be reviewed at 6-weeks, for repeated asthma education and to assess their response to treatment and treatment adherence. 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Attending for outpatient management of asthma at QECH Current tuberculosis treatment Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 6 Year(s) 15 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/06/2018 College of Medicine Research Ethics Committee COMREC
Ethics Committee Address
Street address City Postal code Country
3rd floor, John Chiphangwi Learning Resource Centre, Private Bag 360, Chichiri, Blantyre 3, Malawi Blantyre 999999999 Malawi
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/05/2018 Liverpool School of Tropical Medicine
Ethics Committee Address
Street address City Postal code Country
Pembroke Place, Liverpool, L3 5QA Liverpool 999999999 United Kingdom
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Composite score of current asthma control, measured by Childhood Asthma Control Test Baseline, 3-months
Secondary Outcome Exacerbations requiring hospitalisation, and/or emergency health care use, and/or systemic corticosteroids, in the past 3-months Baseline, 3-months
Secondary Outcome Days absent from school in the past 3-months Baseline, 3-months
Secondary Outcome Lung function - Pre and post bronchodilator FEV1 3-months
Secondary Outcome Exhaled nitric oxide - FeNO 3-months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Queen Elizabeth Central Hospital Chipatala Blantyre Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
National Institute for Health Research Central Commissioning Facility, 15 Church St, Twickenham, TW1 3NL Twickenham United Kingdom
Medical Research Council Polaris House, North Star Avenue, Swindon, SN2 1FL Swindon United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Liverpool School of Tropical Medicine Pembroke Place, Liverpool, L3 5QA Liverpool 999999999 United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
Prof. Kevin Mortimer Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, L3 5QA Liverpool United Kingdom
Prof. Jonathan Grigg Queen Mary University of London London United Kingdom
Dr. Chris Jewell CHICAS, Lancaster University Lancaster United Kingdom
Dr. Kondwani Jambo MLW Clinical Research Programme Blantyre Malawi
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sarah Rylance sarah.rylance@lstmed.ac.uk +265993654329 MLW, PO box 30096, Chichiri, Blantyre 3
City Postal code Country Position/Affiliation
Blantyre Malawi PhD student and consultant paediatrician
Role Name Email Phone Street address
Public Enquiries Sarah Rylance sarah.rylance@lstmed.ac.uk +265993654329 MLW, PO box 30096, Chichiri, Blantyre 3
City Postal code Country Position/Affiliation
Blantyre Malawi PhD student and consultant paediatrician
Role Name Email Phone Street address
Scientific Enquiries Sarah Rylance sarah.rylance@lstmed.ac.uk +265993654329 MLW, PO box 30096, Chichiri, Blantyre 3
City Postal code Country Position/Affiliation
Blantyre Malawi PhD student and consultant paediatrician
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Participant data to include clinical outcomes, spirometry and FeNO levels, by intervention and control groups. Informed Consent Form,Study Protocol Study protocol and informed consent form available to share now. Participant data will be shared following publication of trial results. Data will be open-access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
To be updated No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 11/12/2018 Updated trial start date 12 Sep 2018
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 11/12/2018 Now recruiting - status updated Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 14/07/2020 No change 20 Mar 2020
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 14/07/2020 No change 120
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 14/07/2020 Trial completed Recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Publication URL 20/08/2020 Protocol paper publicly available on MedRXiv https://doi.org/10.1101/2020.08.12.20173401