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

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®.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: Seretide® Diskus® 500/550 μg; Drug: Ultibro® Breezhaler® 110/50 μg; Drug: Spiriva® Respimat® 2,5 μg

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33604
    • CIC-P - Centre François Magendie - G3 - Hôpital Haut-Lévêque

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female aged more than 40 years,
• Written informed consent,
• Diagnosis of COPD according to international guidelines (GOLD 2012),
• Social security or health insurance,
• Women of childbearing potential with a very effective contraception according to the Haute Autorité de Santé (HAS) recommendations.

Exclusion Criteria:

• Previous treatment with Breezhaler®, Diskus® or Respimat® or similar device,
• QT ≥ 450 ms,
• Contraindications to tiotropium: hypersensitivity to tiotropium,
• Contraindications to indacatérol: hypersensitivity to indacatérol,
• Contraindications to salmeterol: hypersensitivity to salmeterol,
• Contraindications to fluticasone: hypersensitivity to fluticasone,
• Contraindications to glycopyrronium: hypersensitivity to glycopyrronium,
• COPD exacerbation within 6 weeks before inclusion,
• Chronic psychiatric disease,
• Medical condition that may affect handling of inhaler devices,
• Subject deprived of his/her liberty,
• Protected adult,
• Subject in exclusion period related to another protocol,
• Pregnant or breastfeeding woman

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1	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
EXPERIMENTAL: Group 2	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
EXPERIMENTAL: Group 3	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of the presence of at least a major error in the use of the inhalation system, from standardized checklist	Day 7 of each treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of non critical errors from standardized checklist		Day 7 of each treatment
Number of non device-dependant errors from standardized checklist		Day 7 of each treatment
Measure of the time necessary for drug administration	Time in second	Up to day 7 of each treatment
Measure of Forced Expiratory Volume in 1 second (FEV1)		At baseline and at day 7
Collection of adverse events		Up to day 66

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Study Chair: Hélène PEYROUZET, Dr, Service Hospitalo-Universitaire de Pharmacologie Médicale

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2017
• Primary Completion (ACTUAL): February 1, 2019
• Study Completion (ACTUAL): March 8, 2019

Study Registration Dates

• First Submitted: June 22, 2016
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (ESTIMATE): June 24, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 14, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: COPD, inhaler device, handling
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Sympathomimetics; Fluticasone-Salmeterol Drug Combination; Tiotropium Bromide
• Other Study ID Numbers: CHUBX 2014/22