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 |
| Secondary identifying numbers | WHO/CAH ID 02002 |
- 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
Scientific
World Health Organization
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
| qazis@who.int |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/04/2003 |
| Completion date | 01/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Months |
| Upper age limit | 5 Years |
| Sex | Both |
| Target number of participants | 396 children |
| 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
CH 1211
Switzerland
Sponsor information
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Research organisation
Research organisation
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
"ROR" |
https://ror.org/01f80g185 |
|---|
Funders
Funder type
Research organisation
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
