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 02002

Study information

Scientific title

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Acute lower airways obstruction

Intervention

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

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

01/04/2003

Overall trial end date

01/11/2005

Reason abandoned

Eligibility

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

Patient

Age group

Child

Gender

Both

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

01/04/2003

Recruitment end date

01/11/2005

Locations

Countries of recruitment

South Africa

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/sites/entrez?cmd=retrieve&db=pubmed&list_uids=16905564

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