Description of the ability to learn how to handle inhaler devices in COPD

Description of the ability to learn how to handle inhaler devices in COPD - INTUITIVE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001435-13-FR

Enrollment

Registered

2016-06-17

Start date

2016-05-19

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Trade Name: Ultibro® Breezhaler® 110/50 µg Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: GLYCOPYRRONIUM BROMIDE CAS Number:

Eligibility

Sex/Gender

All

Inclusion criteria

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 HAS recommendations. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Primary end point(s): Critical errors from standardized checklist;Timepoint(s) of evaluation of this end point: 7 days after the use of every inhaler; Secondary Objective: - Describe, during the various recordings, for every inhalation system (indacaterol-glycopyrronium Breezhaler®, tiotropium Respimat® and salmeterol-fluticasone Diskus®) : . The proportion of subjects presenting at least an error independent from the inhalation system, . The proportion of subjects presenting at least a not major error, . the time necessary mean for the treatment auto-administration - Estimate the observance and the safety of use of every treatment, - Describe the evolution of the FEV1 in presence and in absence of critical errors for every treatment, - Estimate the perception of the efficiency and the satisfaction score of the patients for every treatment, - Estimate the preference of the patient between the 3 inhalers.	—

Measure

Time frame

Main Objective: 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.;Primary end point(s): Critical errors from standardized checklist;Timepoint(s) of evaluation of this end point: 7 days after the use of every inhaler; Secondary Objective: - Describe, during the various recordings, for every inhalation system (indacaterol-glycopyrronium Breezhaler®, tiotropium Respimat® and salmeterol-fluticasone Diskus®) : . The proportion of subjects presenting at least an error independent from the inhalation system, . The proportion of subjects presenting at least a not major error, . the time necessary mean for the treatment auto-administration - Estimate the observance and the safety of use of every treatment, - Describe the evolution of the FEV1 in presence and in absence of critical errors for every treatment, - Estimate the perception of the efficiency and the satisfaction score of the patients for every treatment, - Estimate the preference of the patient between the 3 inhalers.

—

Secondary

Measure	Time frame
Secondary end point(s): - Non critical errors from standardized checklist, - Non device-dependant errors from standardized checklist, - Time necessary for drug administration, - FEV1 at baseline and at day 7, - Patient satisfaction and efficacy questionnaire, - Compliance, - Safety. ;Timepoint(s) of evaluation of this end point: 7 days after the use of every inhaler	—

Countries

France

Contacts

Public ContactREC

CHU de Bordeaux

vincent.dejarnac@chu-bordeaux.fr+33557821097

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026