Trial reportThorax2026
Cytisinicline for smoking cessation in individuals with self-reported COPD: a post hoc analysis of the ORCA-2 and ORCA-3 trials.
Trial report in Thorax, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline in Adult Smokers
A Second Multicenter, Double-blind, Randomized, Placebo-controlled Phase 3 Trial Evaluating the Efficacy and Safety of Cytisinicline in Adult Smokers
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
importanceQuitting smoking is essential for stabilising and improving respiratory function in people with chronic obstructive pulmonary disease (COPD).
objectiveTo evaluate the efficacy and safety of cytisinicline versus placebo for cessation among smokers with and without COPD.
methodsThis post hoc analysis used combined data from the phase 3 ORCA-2 (Ongoing Research of Cytisinicline for Addiction) and ORCA-3 double-blind, placebo-controlled trials. Participants received 6 or 12 weeks of cytisinicline or placebo. Of 1602 participants, 145 (9.3%) self-reported COPD.
interventionsParticipants received 3 mg of cytisinicline three times daily (6 weeks: n=532; 12 weeks: n=534) or placebo (12 weeks: n=536), plus behavioural support. OUTCOME: Biochemically verified continuous smoking abstinence during the last 4 treatment weeks.
resultsCOPD participants were older, smoked longer and had greater nicotine dependence. Cytisinicline was associated with significantly higher smoking abstinence compared with placebo in both COPD and non-COPD subgroups. There was no statistical evidence of heterogeneity in treatment effect between arms. In the 6-week arm, quit estimates were 17.3% versus 2.1% (OR 9.7, p=0.03) for COPD and 19.3% versus 5.5% (OR 4.1, p<0.0001) for non-COPD. In the 12-week arm, quit estimates were 19.1% versus 4.3% (OR 5.3, p=0.04) for COPD and 32.6% versus 8.6% (OR 5.2, p<0.0001) for non-COPD. Cytisinicline was well tolerated with no serious treatment-related events.
conclusionCytisinicline significantly increased quitting for smokers with and without COPD and was well tolerated. The findings support cytisinicline as a viable treatment for smokers with COPD who want to quit. TRIAL REGISTRATION NUMBER: ORCA-2 (NCT04576949) and ORCA-3 (NCT05206370).
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