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Completed

NCT Number: NCT02813200

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

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®.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Bordeaux, 33604, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Seretide® Diskus® 500/550 μg

Drug

Every day during 7 days

Ultibro® Breezhaler® 110/50 μg

Drug

Every day during 7 days

Spiriva® Respimat® 2,5 μg

Drug

Every day during 7 days

Primary outcomes

  1. Assessment of the presence of at least a major error in the use of the inhalation system, from standardized checklist

    Time frame: Day 7 of each treatment

Secondary outcomes

  1. Number of non critical errors from standardized checklist

    Time frame: Day 7 of each treatment

  2. Number of non device-dependant errors from standardized checklist

    Time frame: Day 7 of each treatment

  3. Measure of the time necessary for drug administration

    Time frame: Up to day 7 of each treatment

    Time in second

  4. Measure of Forced Expiratory Volume in 1 second (FEV1)

    Time frame: At baseline and at day 7

  5. Collection of adverse events

    Time frame: Up to day 66

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: INTUITIVE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 24, 2016
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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