Mochizuki 2013.

Study characteristics
Methods	Design: randomised cross‐over study Duration: 12 weeks Location: Japan Setting: single centre
Participants	Population: 44 adults with moderate‐to‐severe COPD Baseline characteristics COPD severity: moderate to severe Age (mean): 75.9 (SE 0.9) years Male 72% Smoking history (mean): Hokunalin tape 59.1 (SE 7.0) pack‐years; salmeterol 51.0 (SE 5.8) pack‐years FEV1: Hokunalin tape 1.14% (SE 0.09%); salmeterol 1.34% (SE 0.11%) Inclusion criteria: aged ≥ 65 years, moderate‐to‐severe COPD, spirometry postbronchodilator FEV1:FVC ratio < 0.70, FEV1 30–80% Exclusion criteria: aged < 65 years, no airway limitation, dementia, previous inhaled medication (β2 agonist, anticholinergics, corticosteroids, patched β2 agonists, skin disorders, severe heart disease, unstable hypertension, other conditions in which patch or treatment with β2 agonists used
Interventions	Treatment arms Intervention: Hokunalin tape 2 mg once daily Control: Salmeterol 50 µg twice daily Allowed co‐medications: previous inhaled medications not allowed
Outcomes	Primary outcomes: adherence (duration for which a participant took a given medication as prescribed), quality of life (SGRQ) Secondary outcomes: 6MWT, adverse events
Notes	Funding: none Identifiers: UMIN000001503
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was achieved using a random sequence generator.
Allocation concealment (selection bias)	Unclear risk	No further information.
Blinding of participants and personnel (performance bias) all outcomes	High risk	Unblinded study design.
Blinding of outcome assessment (detection bias) all outcomes	High risk	Unblinded study design.
Incomplete outcome data (attrition bias) all outcomes	High risk	Attrition was higher in the control group compared to the intervention (22% vs 9%).
Selective reporting (reporting bias)	Unclear risk	Unable to find a protocol for the trial, so unclear if outcomes were reported as planned. Authors reported that outcome measures were conducted at the end of the second phase as it was (quote) "unlikely that they would be affected by the absence of a washout period."
Other bias	Low risk	None identified.