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)

ISRCTN	ISRCTN12666644
DOI	https://doi.org/10.1186/ISRCTN12666644
Protocol serial number	WHO/CAH ID 02002
Sponsor	The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Funder	The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)

Submission date: 27/07/2004
Registration date: 28/07/2004
Last edited: 11/10/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Shamim Qazi
Scientific

World Health Organization
20, Avenue Appia
Geneva -27
CH 1211
Switzerland

Email	qazis@who.int

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/11/2005

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Months
Upper age limit	5 Years
Sex	All
Target sample size at registration	396
Key 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
Key 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
Date of first enrolment	01/04/2003
Date of final enrolment	01/11/2005

Locations

Countries of recruitment

South Africa
Switzerland

Study participating centre

World Health Organization

Geneva -27
CH 1211
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/02/2007		Yes	No