Efficacy of Metered Dose Inhaler (MDI) with attached Bottle spacer for bronchodilator therapy in infants and young children with acute lower airways obstruction (South Africa)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12666644

Enrollment

396

Registered

2004-07-28

Start date

2003-04-01

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

Acute lower airways obstruction Respiratory Acute lower airways obstruction

Interventions

This is an equivalence study. Equivalence will be regarded as not more than an absolute 10% increase in hospitalisation with the bottle spacer. Assuming that hospitalisation with the conventional spa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 3 months to 5 years 2. Able to use MDI - spacer as assessed by the researcher administering inhaled treatment 3. Acute episode of lower airway obstruction (wheezing or hyperinflation) 4. Informed consent of parent/guardian

Exclusion criteria

Exclusion criteria: 1. Use of bronchodilator within the preceeding 4 hours 2. Known underlying cardiac or chronic pulmonary disease (other than asthma) 3. Presence of stridor or daily treatment with oral corticosteroids for more than 2 days prior

Design outcomes

Primary

Measure	Time frame
The need for hospitalisation: this outcome has been chosen as this is clinically important and can be reliably measured. Differences between the two treatment groups for this primary outcome as a result of bias should be minimised by use of random allocation of treatment group with adequate allocation concealment and adequate blinding of the investigators deciding on hospitalisation.	—

Secondary

Measure	Time frame
1. Change in clinical score, measured as the difference between the clinical score at presentation to the clinical score recorded after the final bronchodilator treatment prior to discharge or hospitalisation 2. Change in oximetry, measured as the difference between oximetry recorded at presentation the room air to that recorded after the final bronchodilator treatment prior to discharge or hospitalisation 3. Number of bronchodilator treatments required prior to discharge (if not hospitalised). A bronchodilator treatment will be regarded as 5 puffs of salbutamol or a nebulisation 4. Need for systemic corticosteroids. Systemic steroids will be indicated for children with recurrent wheeze who require hospitalisation or who have required two or more bronchodilator treatments	—

Measure

Time frame

1. Change in clinical score, measured as the difference between the clinical score at presentation to the clinical score recorded after the final bronchodilator treatment prior to discharge or hospitalisation 2. Change in oximetry, measured as the difference between oximetry recorded at presentation the room air to that recorded after the final bronchodilator treatment prior to discharge or hospitalisation 3. Number of bronchodilator treatments required prior to discharge (if not hospitalised). A bronchodilator treatment will be regarded as 5 puffs of salbutamol or a nebulisation 4. Need for systemic corticosteroids. Systemic steroids will be indicated for children with recurrent wheeze who require hospitalisation or who have required two or more bronchodilator treatments

—

Countries

South Africa

Outcome results

None listed

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