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. 2014 Jul 16;2014(7):CD009878. doi: 10.1002/14651858.CD009878.pub2

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
  • Children with mild asthma, diagnosed according to the Chinese Medical Society Respiratory Diseases Branch Asthma Group

  • Not using any corticosteroid in past 6 months before inclusion in the study


EXCLUSION CRITERIA
  • Not reported

Interventions PROTOCOL
DURATION
  • Run‐in = 12 weeks

  • Intervention = 52 weeks


DEVICE: not reported (in translation of the study)
DOSE OF ICS
  • INTERVENTION: beclomethasone dipropionate 200 μg/d

  • CONTROL: beclomethasone dipropionate 400 μg/d


CRITERIA FOR WITHDRAWAL FROM STUDY: reported
Outcomes ANALYSIS: not reported (in translation of the study)
OUTCOMES
GROWTH MEASUREMENT TECHNIQUE: not reported (in translation of the study)
PULMONARY FUNCTION TESTS
  • Bronchial inhalation of histamine provocation test


FUNCTIONAL STATUS
  • Children’s height


BIOMARKERS
  • HPAA function

  • BMD, osteocalcin, serum calcium concentration, serum phosphorus concentration, blood alkaline phosphatase


ADVERSE EVENTS: not reported
WITHDRAWALS: no withdrawals
Notes PUBLICATION: full paper (2001)
FUNDING: not reported
CONFIRMATION OF METHODOLOGY: not received
Study author could not be contacted
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