Study of Inhaler Device Attributes Investigating Critical and Overall Errors, Ease of Use, and Preference Between a Number of Inhaler Devices
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: ELLIPTA; DISKUS/ACCUHALER; MDI; TURBUHALER; HANDIHALER; BREEZEHALER
Intervention description: Dry powder inhaler (placebo) with two blister strips. One placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate.; Placebo inhaler with one blister strip containing lactose monohydrate.; Placebo inhaler containing propellant (1,1,1, 2-Tetrafluoroethane).; Placebo inhaler containing lactose monohydrate.; Placebo inhaler containing lactose monohydrate in a capsule.; Placebo inhaler containing lactose monohydrate in a capsule.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 569.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: BREEZHALER; DISKUS/ACCUHALER; MDI; Inhaler preference; Overall inhaler error; HANDIHALER; Ease of use; TURBUHALER; ELLIPTA; Critical inhaler error

Summary:

      This is a randomised, open-label, placebo, crossover, multicentre study with a single visit.
      The study will comprise five sub-studies. Subjects will receive inactive treatment (placebo)
      via the ELLIPTA® inhaler and one of the other inhaler devices depending on the sub-study they
      are randomised to. Only subjects who are naïve to the ELLIPTA inhaler and to one of the other
      inhaler devices that will be used in this study will be included. Furthermore, subjects who
      are naïve to the BREEZEHALER® and HANDIHALER® inhalers must be naïve to all other inhaler
      devices that requires a capsule. The study will be conducted in the UK and the Netherlands,
      and comprises one visit only. A sufficient number of subjects (at least 600) with COPD will
      be screened and 570 will be randomised to one of five sub-studies. Eligible subjects will be
      allocated to one of the sub-studies depending on their experience of using the other inhaler
      (i.e., depending on which other inhaler they are naïve to).

      This study is designed to assess the proportion of COPD subjects making critical and overall
      (i.e., critical and non-critical errors) errors in using ELLIPTA inhaler and other
      commercially available inhaler devices such as the TURBUHALER®, HANDIHALER, BREEZHALER, MDI
      and DISKUS®/ACCUHALER® inhalers. This study will also assess the 'ease of use' and preference
      between the ELLIPTA inhaler and the other commercially available inhaler devices.

      ELLIPTA, DISKUS, and ACCUHALER are registered trademarks of the GSK group of companies.
      TURBUHALER is a registered trademark of AstraZeneca. HANDIHALER is a registered trademark of
      Boehringer Ingelheim Pharma GmbH & Co. KG. BREEZHALER is a registered trademark of Novartis
      AG.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent: Subject must give their signed and dated written informed consent to
             participate in the study; Subject understands and is willing, able, and likely to
             comply with study procedures and restrictions; Subject must be able to read,
             comprehend, and record information in Dutch and/or English.

          -  Age: >=40 years of age

          -  Gender: Male or female subjects.

          -  Primary diagnosis of COPD: subjects with a clinical history of COPD in accordance with
             the definition by the American Thoracic Society/European Respiratory Society.
             Comorbidities (rheumatoid arthritis or other locomotor problems, visual impairment,
             and depression or anxiety) will be documented as relevant to inhaler use.

          -  COPD treatment: All patients should be currently receiving treatment for COPD.

          -  Must be naïve to using ELLIPTA inhaler and at least one other inhaler device. Subjects
             who are naïve to the BREEZEHALER and HANDIHALER inhalers must be naïve to all other
             inhaler devices that requires a capsule.

        Exclusion Criteria:

          -  Asthma: Subjects with a current diagnosis of asthma only. Note: Subjects with a prior
             history of asthma are eligible if they have a current diagnosis of COPD.

          -  Contraindications: A history of allergy or hypersensitivity to lactose/milk protein or
             magnesium stearate or to any other excipient.

          -  Subjects who are currently participating in another randomised pharmacological
             interventional trial.

          -  Inability to Read: In the opinion of the investigator, any subject who is unable to
             read and/or would not be able to complete a questionnaire and understand verbal
             instructions.