The study will characterise inspiratory flow parameters across placebo dry powder inhaler Easyhaler (2 inhaler versions) and placebo Spiriva inhalation powder capsule inhaled via HandiHaler in patients with chronic obstructive pulmonary disease (COPD) and in healthy volunteers. Substudy: Easyhaler® and HandiHaler® Usability study in patients with COPD; to assess patients acceptability, preference, correct use and ability to learn to use Easyhaler and HandiHaler (with capsules) and to compare PIF rate via In-Check Dial meter with the PIF rate via spirometer in the main study.
This is an open, randomised, multicentre, crossover study with Easyhaler and HandiHaler inhalers. The primary objective is to characterise inspiratory flow parameters across placebo dry powder inhaler Easyhaler (2 inhaler versions) and placebo Spiriva inhalation powder capsule inhaled via HandiHaler in patients with chronic obstructive pulmonary disease (COPD) and in healthy volunteers. The secondary objective is to calculate correlation of peak inspiratory flow (PIF) rate with regards to anthropometric and lung function parameters. Substudy: This is an open, randomised, multicentre, crossover study with Easyhaler and HandiHaler inhalers.There will be 1 study visit per subject, usually this visit is done at the same visit with the main study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
200
Placebo inhalation from inhaler A
Placebo inhalation from HandiHaler
Placebo inhalation from inhaler B
Substudy placebo inhalation
Substudy placebo inhalation
Lung Clinic, Tartu University Hospital
Tartu, Estonia
The primary variable will be the PIF rate through the Easyhaler and HandiHaler inhalers.
After practising, 3 inspiratory flow curves will be recorded and the inhalation with the highest PIF rate analysed.
Time frame: 1 day
Inspiratory volume through the Easyhaler and HandiHaler inhalers
Highest inspiratory volume recorded and analysed from the same inhalation as the PIF rate.
Time frame: 1 day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.