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

NCT02813200 | Completed Phase 4

• 1 other identifier: CHUBX 2014/22
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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®.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD, inhaler device, handling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  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

Study Arms (3)

Group 1

EXPERIMENTAL

Drug: Seretide® Diskus® 500/550 μg; Drug: Ultibro® Breezhaler® 110/50 μg; Drug: Spiriva® Respimat® 2,5 μg

Group 2

EXPERIMENTAL

Drug: Seretide® Diskus® 500/550 μg; Drug: Ultibro® Breezhaler® 110/50 μg; Drug: Spiriva® Respimat® 2,5 μg

Group 3

EXPERIMENTAL

Drug: Seretide® Diskus® 500/550 μg; Drug: Ultibro® Breezhaler® 110/50 μg; Drug: Spiriva® Respimat® 2,5 μg

Interventions

Seretide® Diskus® 500/550 μg DRUG

Every day during 7 days

Group 1; Group 2; Group 3

Ultibro® Breezhaler® 110/50 μg DRUG

Every day during 7 days

Group 1; Group 2; Group 3

Spiriva® Respimat® 2,5 μg DRUG

Every day during 7 days

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• Chronic psychiatric disease,
• Medical condition that may affect handling of inhaler devices,
• Subject deprived of his/her liberty,
• Protected adult,
• Pregnant or breastfeeding woman

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CIC-P - Centre François Magendie - G3 - Hôpital Haut-Lévêque

Bordeaux, 33604, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hélène PEYROUZET, Dr

  Service Hospitalo-Universitaire de Pharmacologie Médicale

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 24, 2016
• Study Start: January 10, 2017
• Primary Completion: February 1, 2019
• Study Completion: March 8, 2019
• Last Updated: February 14, 2022

Record last verified: 2022-02

Locations

FR (1)