Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of death in the world and further increase in its prevalence and mortality has been predicted. Currently, the main long-term treatments are the long-acting beta-2 agonist, indacaterol, salmeterol and the anticholinergic drug, tiotropium and glycopyrronium, used alone or in combination: * long-acting beta-2 agonist with corticosteroid (e.g. salmeterol/fluticasone), * long-acting beta-2 agonist with anticholinergic (e.g. indacatetrol/glycopyrronium). These drugs are delivered to the lung using different inhaler devices such as Breezhaler ®, Handihaler® and Diskus®.
The correct use of inhaler devices is an inclusion criterion in COPD clinical trials. In real life, patients may make many errors using their own inhaler device, which may alter the positive effects observed in clinical trials. The main objective of this study is to describe the handling of inhaler devices (indacaterol-glycopyrronium Breezhaler®, tiotropium Respimat® and salmeterol-fluticasone Diskus®) in patients with COPD. All participants will receive each of the three treatments (Seretide® Diskus® 500/550 μg, Ultibro® Breezhaler® 110/50 μg and Spiriva® Respimat® 2,5 μg). Each treatment will be given daily for one week, followed by a 7-day washout period. On day 1 of each treatment period, the patient will have clinical examination, lung function testing (FEV1) and 2 video recordings: * Video recording #1: inhalation (one puff) without any instruction of use, * Video recording #2: inhalation (one puff) after reading the patient information leaflet. At the end of the visit, the patient will watch a standardized video demonstrating correct inhaler technique. On day 7 of each treatment period, the patient will have clinical examination, lung function testing (FEV1) and 1 video recording of inhaler device use (one puff). 30 days after the last visit, the patient will have a phone contact to collect the adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
Every day during 7 days
Every day during 7 days
Every day during 7 days
CIC-P - Centre François Magendie - G3 - Hôpital Haut-Lévêque
Bordeaux, France
Assessment of the presence of at least a major error in the use of the inhalation system, from standardized checklist
Time frame: Day 7 of each treatment
Number of non critical errors from standardized checklist
Time frame: Day 7 of each treatment
Number of non device-dependant errors from standardized checklist
Time frame: Day 7 of each treatment
Measure of the time necessary for drug administration
Time in second
Time frame: Up to day 7 of each treatment
Measure of Forced Expiratory Volume in 1 second (FEV1)
Time frame: At baseline and at day 7
Collection of adverse events
Time frame: Up to day 66
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.