Baker 1999.
Methods | DESIGN: randomised, double‐blind, placebo‐controlled, parallel‐group study; multi‐centre | |
Participants | SYMPTOMATIC PARTICIPANTS RANDOMLY ASSIGNED: N = 193 INTERVENTION: ICS (budesonide 250 μg/d): 94 CONTROL: ICS (budesonide 500 μg/d): 99 WITHDRAWALS: reported AGE: mean (months) (range): INTERVENTION: ICS (budesonide 250 μg/d): 54.6 (8‐107) CONTROL: ICS (budesonide 500 μg/d): 54.3 (7‐105) GENDER: N (male %): INTERVENTION: ICS (budesonide 250 μg/d): 59 (63) CONTROL: ICS (budesonide 500 μg/d): 62 (63) ASTHMA SEVERITY: moderate persistent asthma ASTHMA DURATION: mean disease duration months (range): INTERVENTION: ICS (budesonide 250 μg/d): 34.2 (2‐92) CONTROL: ICS (budesonide 500 μg/d): 32.4 (4‐96) 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: medication or placebo given by the Pari LC‐Jet Plus nebuliser connected to a Pari Master compressor (Pari Respiratory Equipment, Inc, Richmond, VA) with use of a mouthpiece or face mask DOSE OF ICS
CRITERIA FOR WITHDRAWAL FROM STUDY: reported |
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Outcomes | ANALYSIS: Done in "all patients treated" (intention‐to‐treat). Analysis of variance techniques and Fisher's exact test used OUTCOMES: GROWTH MEASUREMENT TECHNIQUE: not reported PULMONARY FUNCTION TESTS
FUNCTIONAL STATUS
BIOMARKERS
ADVERSE EVENTS: reported WITHDRAWALS: reported |
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Notes | PUBLICATION: full paper (1999) FUNDING: supported in part by Astra USA CONFIRMATION OF METHODOLOGY: not received |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information on sequence generation |
Allocation concealment (selection bias) | Unclear risk | Insufficient information |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding of participants and key study personnel ensured |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding of participants and key study personnel ensured |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | Low risk | Study protocol not available but published reports include all expected outcomes, including those that were prespecified |
Other bias | Low risk | Study apparently free of other sources of bias |