Chen 2001.
Methods | Randomised, single‐blind, placebo‐controlled, parallel‐group study; 1 centre | |
Participants | SYMPTOMATIC PARTICIPANTS RANDOMLY ASSIGNED: N = 20 INTERVENTION: ICS: (beclomethasone dipropionate 200 μg/d): 10 CONTROL: ICS (beclomethasone dipropionate 400 μg/d): 10 WITHDRAWALS: no withdrawals AGE: mean (years) (range): INTERVENTION: ICS (beclomethasone dipropionate 200 μg/d): average 7 years CONTROL: ICS (beclomethasone dipropionate 400 μg/d): average 9 years GENDER: N (male %): not reported ASTHMA SEVERITY: mild asthma ASTHMA DURATION: not reported MEAN (± SD) β2‐AGONIST USE (puffs/d): not reported DOSE OF ICS AT STUDY ENTRY AND AT RUN‐IN: not reported ATOPY (% of participants): not reported ELIGIBILITY CRITERIA
EXCLUSION CRITERIA
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Interventions | PROTOCOL DURATION
DEVICE: not reported (in translation of the study) DOSE OF ICS
CRITERIA FOR WITHDRAWAL FROM STUDY: reported |
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Outcomes | ANALYSIS: not reported (in translation of the study) OUTCOMES GROWTH MEASUREMENT TECHNIQUE: not reported (in translation of the study) PULMONARY FUNCTION TESTS
FUNCTIONAL STATUS
BIOMARKERS
ADVERSE EVENTS: not reported WITHDRAWALS: no withdrawals |
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Notes | PUBLICATION: full paper (2001) FUNDING: not reported CONFIRMATION OF METHODOLOGY: not received Study author could not be contacted |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Using a random number table: “The patients were allocated by random number table and stratified by moderate and severe grades” |
Allocation concealment (selection bias) | Unclear risk | Insufficient information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No blinding or incomplete blinding; single‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No blinding or incomplete blinding; single‐blind |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Reasons for missing outcome data unlikely to be related to true outcomes |
Selective reporting (reporting bias) | Unclear risk | Insufficient information |
Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists |