Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Shamim Qazi


Contact details

World Health Organization
Avenue Appia
Geneva -27
CH 1211

Additional identifiers

EudraCT number number

Protocol/serial number

WHO/CAH ID 02002

Study information

Scientific title


Study hypothesis

To compare the response to bronchodilator administered via a Metered Dose Inhaler (MDI) with bottle spacer compared to a MDI with conventional spacer in young children presenting to a health care facility with acute lower airways obstruction.

Ethics approval

Ethics approval received from:
1. University of Cape Town Research and Ethics Committee, University of Cape Town
2. World Health Organization (WHO) Ethical Review Committee

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Acute lower airways obstruction


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 spacer will occur in 20% of children and that the spacers are equally effective, 198 children will be required in each group (total sample of 396 children) to demonstrate that hospitalisation with the bottle spacer is not more than 10% higher, with 80% power and a one-tailed a of 0.0505 i.e. given the above assumptions, the upper 90% confidence limit for a difference favouring the conventional spacer will be less than 10%.

Three different delivery systems will be compared:
1. Conventional spacer with MDI - a small volume (150 ml) valved spacer with an attached mask for children less than 3 years, and a mouthpiece for those 3 - 5 years
2. Modified 500 ml plastic bottle with MDI with attached mask for children less than 3 years
3. Jet nebuliser with attached mask or mouthpiece depending upon child's age

Intervention type



Not Specified

Drug names

Primary outcome measure

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 outcome measures

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

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants

396 children

Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment

South Africa

Trial participating centre

World Health Organization
Geneva -27
CH 1211

Sponsor information


The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)

Sponsor details

Avenue Appia
Geneva -27
CH 1211

Sponsor type

Research organisation



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


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

Basic results (scientific)

Publication list

Results in

Publication citations

  1. Results

    Zar HJ, Streun S, Levin M, Weinberg EG, Swingler GH, Randomised controlled trial of the efficacy of a metered dose inhaler with bottle spacer for bronchodilator treatment in acute lower airway obstruction., Arch. Dis. Child., 2007, 92, 2, 142-146, doi: 10.1136/adc.2006.101642.

Additional files

Editorial Notes