Contact information
Type
Scientific
Primary contact
Dr Shamim Qazi
ORCID ID
Contact details
World Health Organization
20 Avenue Appia
Geneva-27
CH 1211
Switzerland
qazis@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
WHO/CAH ID 99025
Study information
Scientific title
Acronym
Study hypothesis
Using current World Health Organization (WHO) guidelines, children with wheezing are being over-prescribed antibiotics and bronchodilators are under utilised. To improve the WHO case management guidelines, more data is needed about the clinical outcome in children with wheezing/pneumonia overlap.
Ethics approval
Ethics approval received fron:
1. Institutional Review Board (IRB) of Pakistan Institute of Medical Sciences, Islamabad, Pakistan
2. IRB of Queen Sirikit National Institute of Child Health, Bangkok, Thailand
3. World Health Organization (WHO) Ethical Review Committee
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Wheeze and fast breathing
Intervention
1. Inhaled Salbutamol and reassessment after up to three cycles of bronchodilator therapy repeated at 15 minute interval if necessary
2. Metered Dose Inhaler (MDI) with spacer device
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Proportions of children aged 1 - 59 months with auscultatory wheeze and fast breathing or lower chest indrawing:
1. Respond to up to three cycles of inhaled salbutamol: response defined as no fast breathing or lower chest indrawing present
2. Fail therapy at day 3 or days 5 - 7 of the initial successful bronchodilator therapy with inhaled salbutamol? Therapy failure defined as:
2.1. Relapse: develop fast breathing or chest indrawing afresh, that does not respond to three cycles of inhaled salbutamol
2.2. Development of any danger sign (except wheezing and fever in young infant)
2.3. Death
2.4. Severe adverse reaction to salbutamol
Secondary outcome measures
In children aged 1 - 59 months with auscultatory wheeze and fast breathing or lower chest indrawing:
1. Proportion with audible wheeze at initial assessment
2. Proportion of responders to up to three cycles of inhaled salbutamol associated with:
2.1. Age
2.2. Respiratory Syncytial Virus (RSV) isolation
2.3. Season
2.4. Number of previous wheezing episodes
2.5. Audible versus auscultatory wheeze
2.6. Family history of asthma
3. Proportion of relapses in children who showed initial improvement associated with:
3.1. Age
3.2. RSV isolation
3.3. Season
3.4. Number of previous wheezing episodes
3.5. Audible versus auscultatory wheeze
3.6. Family history of asthma
4. Received any antibiotic for this or any concurrent illness before follow-up
5. Loss to follow-up
6. Withdrawal of consent
Overall trial start date
01/05/2001
Overall trial end date
01/04/2002
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 1 to 59 months
2. Audible/auscultatory wheeze
3. Respiratory rate above age specific cut off point or lower chest indrawing
4. Classified as no pneumonia with wheeze
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
1622
Participant exclusion criteria
1. Presence of danger sign:
1.1. Up to two months: stopped feeding well, drowsy, convulsions, stridor in a calm child, fever
1.2. 2 - 59 months: convulsions, clinically severe malnutrition, unable to drink
2. Antibiotics during last 48 hours
Recruitment start date
01/05/2001
Recruitment end date
01/04/2002
Locations
Countries of recruitment
Pakistan, Thailand
Trial participating centre
World Health Organization
Geneva-27
CH 1211
Switzerland
Sponsor information
Organisation
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Sponsor details
20
Avenue Appia
Geneva -27
CH 1211
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=15499063
Publication citations
-
Results
Hazir T, Qazi S, Nisar YB, Ansari S, Maqbool S, Randhawa S, Kundi Z, Asghar R, Aslam S, Assessment and management of children aged 1-59 months presenting with wheeze, fast breathing, and/or lower chest indrawing; results of a multicentre descriptive study in Pakistan., Arch. Dis. Child., 2004, 89, 11, 1049-1054, doi: 10.1136/adc.2003.035741.