A Clinical Study Assessing Critical Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA® Dry Powder Inhaler, in Comparison to Combinations of Dry Powder Inhalers Used to Provide Triple Therapy, in Patients With Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Placebo ELLIPTA; Placebo DISKUS; Placebo TURBUHALER; Placebo HANDIHALER; PQ1; PQ2; PQ3; PQ4
Intervention description: It is a dry powder inhaler device that can hold two individual blisters: one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate.; It is a placebo dry powder inhaler with one blister strip containing lactose monohydrate.; It is a placebo dry powder inhaler containing lactose monohydrate.; Placebo capsules contain lactose monohydrate in the form of powder for oral inhalation, to be used with HANDIHALER device.; Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions, but differ in the ordering of inhalers in their responses.; Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions.; Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions.; Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: HANDIHALER; ELLIPTA; TURBUHALER; DISKUS; COPD; critical error; inhaler preference

Summary:

      This is a randomized, multi-centre, open-label, placebo-device, cross-over study, with a 2x2
      complete block design in subjects with chronic obstructive pulmonary disease (COPD) to assess
      the benefits of delivering triple therapy using a single ELLIPTA dry powder inhaler (DPI)
      (closed triple therapy) versus delivering triple therapy using two different types of DPI
      (open triple therapy). The primary objective of the study is to evaluate the proportion of
      COPD subjects who make critical errors when using a single ELLIPTA DPI versus those using
      combinations of DISKUS® with HANDIHALER®, or TURBUHALER® with HANDIHALER. At Visit 1, all
      subjects will demonstrate the use of ELLIPTA DPI, and HANDIHALER DPI in combination with
      either DISKUS DPI (in sub-study 1) or TURBUHALER DPI (in sub-study 2), based on the treatment
      sequences. At the end Visit 1, subjects will complete the inhaler preference questionnaire
      (PQ). There is no active treatment and subjects will continue to take their own prescribed
      COPD medication for the duration of the study. ELLIPTA and DISKUS are registered trademarks
      of the GSK group of companies; TURBUHALER is a registered trademark of AstraZeneca and
      HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG.
    

Eligibility criteria:

        Inclusion Criteria

          -  Age >=40 years at Visit 1

          -  Diagnosis of COPD with a documented history of COPD, in accordance with the definition
             by the European Respiratory Society.

          -  Current COPD Therapy: Currently receiving maintenance therapy with a fixed dose
             combination of a long-acting beta 2-agonist (LABA) and inhaled corticosteroid (ICS).
             Subject may also be receiving long-acting muscarinic antagonist (LAMA; also known as a
             long-acting anti-cholinergic). Subjects must be able to continue using their currently
             prescribed COPD maintenance inhaler therapy throughout the study and as needed short
             acting beta-adrenergic agonist (SABA) and/or short acting muscarinic antagonist (SAMA)
             for rescue use.

          -  Has been on current maintenance ICS/LABA COPD treatment for at least 4 weeks prior to
             V0 and evaluated as unlikely to change treatment within 4 weeks of Visit 1.

          -  Current or former (defined as subjects who have quit smoking for at least 3 months
             prior to V0/V1) cigarette smokers with a >10 pack-year smoking history (Number of pack
             years=[number of cigarettes per day ÷ 20] x number of years smoked [e.g., 10
             pack-years is equal to 20 cigarettes per day for 10 years, or 10 cigarettes per day
             for 20 years]).

          -  Males or females who are not pregnant or not planning a pregnancy during the study or
             not lactating

          -  Capable of giving signed informed consent which includes compliance with the
             requirements and restrictions listed in the informed consent form (ICF) and in this
             protocol.

        Exclusion Criteria

          -  Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma
             are eligible if they have a current diagnosis of COPD.

          -  Subjects who used any ELLIPTA inhaler (participated in a clinical study of GW685698,
             GW642444, GSK573719 [fluticasone furoate, vilanterol, umeclidinium bromide], or any
             combination thereof, or placebo in an ELLIPTA inhaler study) within 24 months prior to
             Visit 0.

          -  Subjects who used any capsule system inhaler (e.g. Spiriva HANDIHALER,
             SEEBRI®/ULTIBRO® BREEZHALER®, or participated in a clinical studies of these,
             including placebo inhalers) within 24 months prior to Visit 0. SEEBRI, ULTIBRO, and
             BREEZHALER are registered trademarks of Novartis AG.

          -  Dependent on which sub-study a subject is included on they should not have any recent
             experience, within 24 months of V 0 of the following inhaler for the sub study
             included on: Sub Study 1: DISKUS inhaler (e.g., Seretide DISKUS or placebo DISKUS) and
             Sub Study 2:TURBUHALER (e.g. Symbicort TURBUHALER or placebo TURBUHALER)

          -  Subjects with a known or suspected alcohol or drug abuse at Visit 1 which in the
             opinion of the investigator could interfere with the subject's proper completion of
             the protocol requirement

          -  A history of hypersensitivity to any components of the study inhaler (e.g., lactose,
             magnesium stearate). In addition, subjects with a history of severe milk protein
             allergy that, in the opinion of the study physician, contraindicates participation
             will also be excluded.

          -  Subjects who have received an investigational drug and/or medical device within 30
             days of entry into this study (Screening/Visit 1), or within five drug half-lives of
             the investigational drug, whichever is longer

          -  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.