Methods | Country: Denmark Aim: To evaluate the effect of varenicline on tobacco cessation in young smokers suffering from asthma Dates conducted: Not stated Study Design: Double‐blind placebo‐controlled RCT |
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Participants | 52 young (aged 19 ‐ 40) smokers with asthma, randomised to varenicline (26) or placebo (26). CPD ≥ 10; FTND 5.6 | |
Interventions | 1. Varenicline: presumed standard regimen: Varenicline 1.0 mg x 2/day 2. Placebo tablet x 2/day No further details |
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Outcomes | Primary: presumed PPA at 12 wks Secondary: presumed PPA at 0, 6, 24 wks Validation by expired CO < 10 ppm Also assessed asthma symptom score, general health quality score (15D) and methacholine challenge |
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Treatment type | Medication: VARENICLINE | |
Notes | Author supplied further details | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated. ""randomized, placebo‐controlled, double‐blinded trial" |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not stated. "double‐blinded |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not stated; ITT analysis conducted |
Selective reporting (reporting bias) | Unclear risk | Not stated |
Other bias | Unclear risk | Not stated |