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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— INTUITIVE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813200
• Other study ID #: CHUBX 2014/22
• Status: Completed
• Phase: Phase 4
• Start date: January 10, 2017
• Est. completion date: March 8, 2019

Study information

• Verified date: February 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 8, 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Seretide® Diskus® 500/550 µg
Every day during 7 days
• Ultibro® Breezhaler® 110/50 µg
Every day during 7 days
• Spiriva® Respimat® 2,5 µg
Every day during 7 days

Locations

Country	Name	City	State
France	CIC-P - Centre François Magendie - G3 - Hôpital Haut-Lévêque	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

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