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. 2021 Sep 8;2021(9):CD013381. doi: 10.1002/14651858.CD013381.pub2

EUCTR2016‐001435‐13‐FR.

Methods Study design: cross‐over randomised trial
Duration: 7 days
Location: France
Participants Population: COPD (GOLD)
Baseline characteristics: NR
Inclusion criteria: adults aged ≥ 40 years, written informed consent, COPD diagnosis (GOLD 2012), health insurance or social security, women of childbearing age
Exclusion criteria: previous use of Breezhaler, Diskus or Respimat or similar device; QT ≥ 450 ms; hypersensitivity to any of the study medications (tiotropium, indacatérol, salmeterol, fluticasone, glycopyrronium); exacerbations in the last 6 months; long‐term psychiatric conditions; inability to use inhaler devices; protected adult; excluded from other study; pregnant or breastfeeding
Interventions Treatment arms
  1. Seretide Diskus 500/550 μg

  2. Ultibro Breezhaler 110/50 μg

  3. Spiriva Respimat 2.5 μg


All groups received all 3 inhalers in cross‐over format. All participants received 2 video recordings:
  1. inhalation (1 puff) without any instruction of use

  2. inhalation (1 puff) after reading the patient information leaflet

Outcomes Primary outcome: assessment of the presence of at least a major error in the use of the inhalation system, from standardised checklist
Secondary outcomes: number of non‐critical errors from standardised checklist, number of non‐device‐dependent errors from standardised checklist, measure of time for necessary drug administration, FEV1, adverse events
Notes Funding: University Hospital Bordeaux
Identifier: NCT02813200 or CHUBX 2014/22
Principal investigator: Dr Pierre‐Olivier Girodet (pierre‐olivier.girodet@chu‐bordeaux.fr)