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
All groups received all 3 inhalers in cross‐over format. All participants received 2 video recordings:
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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) |