Assessment and management of children aged 1 - 59 months presenting with wheeze and fast breathing: multicenter study in Pakistan and Thailand

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN32365107

Enrollment

1622

Registered

2004-07-28

Start date

2001-05-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wheeze and fast breathing Respiratory Respiratory problems

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Pakistan, Thailand

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026