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

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ClinicalTrials.gov Identifier: NCT02813200
Recruitment Status : Unknown
Verified June 2016 by University Hospital, Bordeaux.
Recruitment status was:  Not yet recruiting
First Posted : June 24, 2016
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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®.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Seretide® Diskus® 500/550 μg Drug: Ultibro® Breezhaler® 110/50 μg Drug: Spiriva® Respimat® 2,5 μg Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Study Start Date : September 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : August 2017

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813200


Contacts
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Contact: Pierre-Olivier GIRODET, Dr (0)5 57 62 31 94 ext +33 pierre-olivier.girodet@chu-bordeaux.fr
Contact: Virginie NIEL (0)5 57 62 31 94 ext +33 virginie.niel@chu-bordeaux.fr

Locations
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France
CIC-P - Centre François Magendie - G3 - Hôpital Haut-Lévêque Not yet recruiting
Bordeaux, France, 33604
Contact: Pierre-Olivier GIRODET, Dr    (0)5 57 62 31 94 ext +33    pierre-olivier.girodet@chu-bordeaux.fr   
Contact: Virginie NIEL    (0)5 57 62 31 94 ext +33    virginie.niel@chu-bordeaux.fr   
Principal Investigator: Pierre-Olivier GIRODET, Dr         
Sub-Investigator: Patrick BERGER, Pr         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Study Chair: Hélène PEYROUZET, Dr Service Hospitalo-Universitaire de Pharmacologie Médicale

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02813200     History of Changes
Other Study ID Numbers: CHUBX 2014/22
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016
Keywords provided by University Hospital, Bordeaux:
COPD, inhaler device, handling
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Fluticasone-Salmeterol Drug Combination
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action