Preference Attributes of ELLIPTA Dry Powder Inhaler (DPI) and HANDIHALER DPI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Placebo ELLIPTA device; Placebo capsules for use in HANDIHALER device; Inhaler Preference Questionnaire Version 1; Inhaler Preference Questionnaire Version 2
Intervention description: Placebo ELLIPTA is a DPI device containing powder for inhalation, to be inhaled orally once daily for 5-9 days. It contains two strips with 30 blisters per strip - one strip contains lactose monohydrate whereas the other strip contains lactose monohydrate blended with magnesium stearate.; Placebo capsules contain lactose monohydrate in the form of powder for inhalation, to be used with the HANDIHALER inhaler as an oral inhalation once daily for 5-9 days.; Consists of 5 questions to assess subjects' preference of device attributes and dosing regimens. The two versions of the questionnaire ask the same questions, but differ in the ordering of inhalers in their responses.; Consists of 5 questions to assess subjects' preference of device attributes and dosing regimens. The two versions of the questionnaire ask the same questions, but differ in the ordering of inhalers in their responses.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 214.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: HANDIHALER; Dry Powder Inhaler; COPD; ELLIPTA; Inhaler preference attributes

Summary:

      This is a Phase IV multi-center, randomized, open-label, cross-over, placebo study in
      subjects with Chronic Obstructive Pulmonary Disease (COPD) to compare inhaler-specific
      preference attributes of two inhalers - ELLIPTA dry powder inhaler (DPI) and the HANDIHALER
      DPI. The primary objective of this study is to evaluate whether more subjects with COPD
      prefer the ELLIPTA inhaler to the HANDIHALER DPI based on the number of steps needed to take
      medication.

      All subjects will use the ELLIPTA inhaler and the HANDIHALER inhaler in the corresponding
      treatment periods based on the randomisation scheme, and at the end of 2 periods, complete
      the inhaler preference questionnaire. Subjects will self-administer the inhalation once daily
      for 5-9 days in each treatment period.

      This study will be placebo-only, and neither inhaler will contain active treatment. Subjects
      will continue their current COPD medication(s) as prescribed, and will follow up with their
      regular physician for their COPD healthcare during the study.

      Approximately 211 subjects will be enrolled in the study.

      ELLIPTA is a trademark of the GlaxoSmithKline group of companies. HANDIHALER is a trademark
      of Boehringer Ingelheim International GmbH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >=40 years of age at Visit 1.

          -  Diagnosis of COPD with a documented history of COPD for at least 6 months.

          -  Severity of Disease: Post albuterol/salbutamol forced expiratory volume in one second
             (FEV1)/forced vital capacity (FVC) ratio <0.70 and FEV1 <=70% of predicted obtained
             within two years of Visit 1.

          -  Smoking History: Current or former (defined as subjects who have quit smoking for at
             least 3 months prior to Screening/Visit 1) cigarette smokers with a >10 pack-year
             smoking history. Number of pack years = (number of cigarettes per day/20) x number of
             years smoked (for example, 10 pack-years is equal to 20 cigarettes per day for 10
             years, or 10 cigarettes per day for 20 years).

          -  Current COPD Therapy:

               1. Currently receiving maintenance therapy with one or more long-acting
                  bronchodilators, such as a long-acting muscarinic antagonist (LAMA; also known as
                  a long-acting anti-cholinergic), long-acting beta 2-agonist (LABA), or inhaled
                  corticosteroid (ICS)/LABA combination for the treatment of COPD. 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) or short acting muscarinic antagonist (SAMA) for rescue use.

               2. Has been on current maintenance COPD treatment for at least 4 weeks prior to
                  Screening/Visit 1 and evaluated as unlikely to change COPD treatment within 4
                  weeks of Visit 1.

          -  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 defined for this 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 English.

        Exclusion Criteria:

          -  Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of
             asthma are eligible if they have a current diagnosis of COPD.

          -  Recent experience with the ELLIPTA inhaler: Subjects who used any ELLIPTA inhaler
             within 6 months (180 days) prior to Visit 1.

          -  Recent experience with the HANDIHALER inhaler: Subjects who used any HANDIHALER
             inhaler within 6 months (180 days) prior to Visit 1.

          -  Poorly controlled COPD: Subjects with symptoms of poorly controlled COPD such as:

               1. Acute worsening of COPD that is managed by the subject with corticosteroids or
                  antibiotics or that requires treatment prescribed by a physician, in the 4 weeks
                  prior to Visit 1.

               2. Hospitalization due to acute worsening of COPD within 4 weeks of Visit 1.

               3. Use of a total of 8 puffs/day or more of short-acting symptom relief medications
                  such as albuterol and ipratropium for 2 consecutive days or any 3 days within 7
                  days immediately preceding Visit 1.

               4. Changes in COPD symptoms and signs, suggesting worsening COPD health status at
                  Visit 1.

          -  Other Disease Abnormalities:

               1. Subjects with suspected or evidence of oropharyngeal candidiasis.

               2. Historical or current evidence of clinically significant or rapidly progressing
                  or unstable cardiovascular, neurological, renal, hepatic, immunological,
                  endocrine (including uncontrolled diabetes or thyroid disease) or haematological
                  abnormalities that are uncontrolled. Significant is defined as any disease that,
                  in the opinion of the investigator, would put the safety of the subject at risk
                  through participation, or which would affect the analysis if the
                  disease/condition exacerbated during the study.

               3. Subjects with a history of psychiatric disease, intellectual deficiency, poor
                  motivation or other conditions that will limit the validity of informed consent
                  to participate in the study.

          -  Compliance: Subjects at risk of non-compliance, or unable to comply with the study
             procedures, or unable to continue their current COPD medications.

          -  Drug/alcohol abuse: 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.

          -  Drug/Food Allergy: A history of hypersensitivity to any components of the study
             inhaler (for example, 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.

          -  Investigational Product: 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.

          -  Affiliation with Investigator's Site: A subject will not be eligible for this study if
             he/she is an immediate family member of the participating investigator,
             sub-investigator, study coordinator, or employee of the participating investigator.