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
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
-
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.