Condition category
Respiratory
Date applied
27/07/2004
Date assigned
28/07/2004
Last edited
11/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.who.int/child-adolescent-health/

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

  1. 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.

Additional files

Editorial Notes