Ammari 2015.
| Study characteristics | ||
| Methods |
Design: parallel‐group randomised controlled trial; blinding not stated Duration: 12 weeks Setting: paediatric respiratory outpatient clinics at NHS teaching hospitals in UK Trial registration: not reported |
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| Participants |
Population: 80 children with asthma randomised to AeroChamber Plus with Flow‐Vu (FV) (n = 40) or AeroChamber Plus (AC) (n = 40) Age: children aged 1 to 5 years; mean age (SD) in the intervention group 2.8 (0.93) years, and in the control group 3.4 (1.09) years Baseline asthma severity: intervention group: "partly controlled ‐ or uncontrolled asthma"; baseline ACQ (SD): 1.75 (0.54); PAQLQ (total) (SD): 5.34 (0.90). Control group: "partly controlled ‐ or uncontrolled asthma"; baseline ACQ (SD): 1.91 (1.11); PAQLQ (total) (SD): 4.97 (1.05) Inclusion criteria: children aged 1 to 5 years with partially controlled or uncontrolled asthma according to GINA (2008) criteria and receiving parentally supervised inhalation therapy, including an inhaled corticosteroid, via a pMDI plus a spacer device Exclusion criteria: inhalation treatment had been changed over the 4 weeks before enrolment, using a dry powder inhaler or a breath‐activated pMDI, limited physical or mental ability to use a spacer or to follow study procedures, had other chronic disease conditions at study enrolment that might adversely affect their quality of life Percentage withdrawn: No participants withdrew from the trial Other allowed medication: "No change in the asthma medications was recorded for all participants throughout the study period" |
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| Interventions |
Intervention summary: AeroChamber Plus with Flow‐Vu: designed with a visual feedback reassurance mechanism of an optimal inhalation; 4 visits over 12 weeks; visit 1 training given on correct use of AC. Randomisation occurred at visit 2, during which training on correct use of FV was given. 2 further follow‐up visits at 6 and 12 weeks post randomisation Control summary: currently available AeroChamber device, which does not have the visual feedback indicator; 4 visits over 12 weeks; visit 1 training given on correct use of AC. Randomisation occurred at visit 2, with further training on use of AC provided. 2 further follow‐up visits at 6 and 12 weeks post randomisation |
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| Outcomes |
Outcomes measured: peak inspiratory flow (PIF), quality of life (PAQLQ), asthma control (ACQ), parent spacer preference on Likert scale Technique assessment method used: PIF was used as a measure of inhaler technique |
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| Notes |
Type of publication: single peer‐reviewed journal article Funding: Trudell Medical International, Canada: unconditional grant for the use of facilities at clinics used in the study |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The children were randomised to use the AC or the FV according to a pre‐study designed randomisation table" |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No description of procedures intended to blind participants or personnel to group assignment; outcomes such as PAQLQ and ACQ are subjective and may be at risk of performance bias |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | No description of procedures intended to blind outcome assessors to group assignment; for outcomes such as PAQLQ and ACQ, participant/caregiver was the outcome assessor; therefore these outcomes may be at risk of detection bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No drop‐out |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified. However, all outcomes listed in Methods clearly reported in paper |
| Other bias | Low risk | None noted |