Comparative Study of ELLIPTA Dry Powder Inhaler (DPI) Versus DISKUS DPI Used With 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: ELLIPTA placebo DPI; DISKUS placebo DPI; HandiHaler placebo DPI; Inhaler preference questionnaires
Intervention description: ELLIPTA is a dry powder inhaler used via oral route. It will be a placebo DPI with two strips with 30 blisters per strip. First strip will contain lactose monohydrate and the second strip will contain lactose monohydrate blended with magnesium stearate.; DISKUS is a dry powder inhaler used via oral route. It will be a placebo DPI with one blister strip that will contain lactose monohydrate.; HandiHaler is a dry powder inhaler used via oral route. It will be a DPI with placebo capsules that will contain lactose monohydrate.; Preference questionnaires will be given to subjects to understand the inhaler preference. There will be 2 types of questionnaire, preference questionnaires 1 and 2, which will be randomized at visit 3 (Day 56).
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will be randomized to receive a placebo ELLIPTA inhaler QD or a placebo DISKUS BID with placebo HandiHaler QD inhaler at Visit 1 and Visit 2 in a cross-over manner followed by Preference Questionnaire 1 or 2
Masking: None (Open Label)
Masking description: This will an open-label study and blinding will not be performed.
Enrollment: 240.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: DISKUS; HandiHaler; COPD; Placebo; Cross-over; Dry powder inhaler; ELLIPTA

Summary:

      This randomized, cross over study aims to find out the benefits of delivering triple therapy
      using a single ELLIPTA® DPI (fixed-dose combination triple therapy) versus delivering triple
      therapy using two different types of inhalers (open triple therapy) including DISKUS® with
      HandiHaler® to subjects with COPD. Correct inhaler use, critical errors and performance
      attributes will also be assessed. Approximately 240 subjects with COPD will be randomized in
      the study. The study will be conducted in 3 visits and will be completed in approximately 56
      days. At Visit 1 (Day 1) and Visit 2 (Day 28) subjects will be randomized to receive a
      placebo ELLIPTA inhaler once daily (QD) or a placebo DISKUS twice daily (BID) with placebo
      HandiHaler QD inhaler in 1:1 ratio in a cross-over manner for the study period (28 days for
      each period). At Visit 3 (Day 56), subjects will be asked to complete preference
      questionnaire 1 or 2. There will be no active treatment and subjects will continue to take
      their own prescribed COPD maintenance and rescue medication during the entire study period.
      ELLIPTA and DISKUS are the registered trademarks of GlaxoSmithKline group of companies.
      HandiHaler is the registered trademark of Boehringer Ingelheim group of companies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be capable of giving signed informed consent.

          -  Subjects must have a diagnosis of COPD with a documented history of COPD for at least
             12 months, in accordance with the definition by the American Thoracic Society/European
             Respiratory Society.

          -  Subjects must be 40 years of age inclusive, at the time of signing the informed
             consent.

          -  Male or female subjects will be included. Females must not be pregnant or planning
             pregnancy during the study or not lactating.

          -  Subjects must have a documented post albuterol 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.

          -  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
             (example, 10 pack-years is equal to 20 cigarettes per day for 10 years, or 10
             cigarettes per day for 20 years].

          -  All subjects should be currently receiving maintenance treatment for COPD for at least
             4 weeks prior to Randomization/Visit 1 and evaluated as unlikely to change COPD
             treatment within 4 weeks of Visit 1.

          -  All subjects should be able to stay on their prescribed maintenance COPD inhaler (s)
             without change throughout the entire treatment period.

          -  Subjects must be able to read, comprehend, and record information in English.

        Exclusion Criteria:

          -  Subjects must not have a current diagnosis of asthma.

          -  Subjects must not have used the ELLIPTA, DISKUS, or HandiHaler inhalers in the 12
             months prior to Visit 1.

          -  Subjects must not be receiving their current COPD medications with the ELLIPTA,
             DISKUS, or HandiHaler inhalers.

          -  Subjects must not be receiving only inhaled short-acting beta-adrenergic agonists,
             i.e., albuterol as their daily COPD therapy (as needed or regularly scheduled).

          -  Subjects must not have experienced more than 1 COPD exacerbation which required
             hospitalization in the 12 months prior to Visit 1.

          -  Subjects must not have a known or suspected history of alcohol or drug abuse within
             the last 2 years.

          -  Subjects must not have a history of hypersensitivity to any component of the study
             inhalers (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.

          -  Subjects with other respiratory disorders, including active tuberculosis, active lung
             cancer, sarcoidosis, lung fibrosis, pulmonary hypertension, or pulmonary disease
             (including but not confined to asthma, bronchiectasis with the need for treatment,
             cystic fibrosis, and bronchopulmonary dysplasia), interstitial lung diseases or other
             active pulmonary diseases.

          -  Subjects with 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 hematological
             abnormalities that are uncontrolled. Significant is defined as any disease that, in
             the opinion of the investigator, would put the safety of the participant at risk
             through participation, or which would affect the analysis if the disease/condition
             exacerbated during the study will be excluded.

          -  Subjects with history of psychiatric disease, intellectual impairment, poor motivation
             or other conditions that will limit the validity of informed consent to participate in
             the study will be excluded.

          -  Subjects at risk of non-compliance, or unable to comply with the study procedures, or
             unable to continue their current medications.

          -  Subjects who have received an investigational drug and/or medical device/inhaler
             within 30 days of entry into this study (Screening/Visit 1), or within five drug
             half-lives of the investigational drug, whichever is longer.

          -  Subjects 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.