NCT02813200

Description of the Ability to Learn How to Handle Inhaler Devices in COPD

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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®.

Detailed description

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.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	Seretide® Diskus® 500/550 μg	Every day during 7 days
DRUG	Ultibro® Breezhaler® 110/50 μg	Every day during 7 days
DRUG	Spiriva® Respimat® 2,5 μg	Every day during 7 days

Timeline

• Start date: 2017-01-10
• Primary completion: 2019-02-01
• Completion: 2019-03-08
• First posted: 2016-06-24
• Last updated: 2022-02-14

Locations

1 site across 1 country: France