Ease of Use and Correct Use Study of Placebo ELLIPTA® Inhaler in COPD Subjects
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Placebo; Questionnaire
Intervention description: Subjects will receive 1 inhalation once-daily until visit 2.; ELLIPTA Inhaler Ease of Use Questionnaire is a four-point Likert scale. This questionnaire will be filled by investigator (designee) based on responses received from subject. Responses for the questionnaire are Very difficult, Difficult, Easy, Very easy. Subjects will be give either version A or B at Visit 2.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 278.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Placebo; ELLIPTA inhaler; Correct use; COPD; Ease of use

Summary:

      Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease
      characterized by airflow limitation that is not fully reversible. The mainstay for treatment
      involves the use of inhaled medications, including short and/or long-acting bronchodilators
      along with inhaled corticosteroids. For inhaled medications, the choice of inhalation device
      is an important consideration because an inadequate technique reduces the effects of
      inhalation. Therefore, the development of an easy-to-use inhaler that delivers the drug to
      the lungs effectively, is important. This study will assess the correct use of the ELLIPTA
      inhaler by subjects with COPD and to assess ease of use of the ELLIPTA inhaler, as rated by
      those subjects determined to be using the inhaler correctly. Study will be divided into two
      visits i.e. Screening/Visit 1 (day 1) and Visit 2 (Day 28 +/-2) with a phone call on Day
      8+/-2 days of Visit 1 to assess safety. In this multi-center, single-arm, randomised (to
      receive one of two versions of the ELLIPTA inhaler Ease of Use questionnaires), open-label,
      placebo study, only subjects who are have never used the ELLIPTA inhaler before and have an
      established diagnosis of COPD and receiving COPD therapy and are able to demonstrate correct
      use of the ELLIPTA inhaler at Visit 1 will be considered eligible to participate in this
      study. Approximately 252 subjects will be screened with an expectation of 208 subjects
      completing the study while demonstrating correct ELLIPTA inhaler use at visit 2.

      ELLIPTA is a registered trademark of the GlaxoSmithKline Group of Companies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: >=40 years of age at Visit 1

          -  Diagnosis of COPD with a documented history of COPD for at least one year, in
             accordance with the definition by the American Thoracic Society/European Respiratory
             Society.

          -  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 divided by 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]).

          -  Current COPD Therapy: Currently receiving maintenance (with one or more long-acting
             bronchodilators, such as a long-acting muscarinic antagonist (LAMA; also known as a
             long-acting anti-cholinergic) or long-acting beta 2-agonist (LABA) inhaler therapy
             (with no prior or ongoing use of ELLIPTA inhaler) 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)
             for rescue use.

          -  Ability to Use Inhalers: Subject must be able to demonstrate correct use of ELLIPTA
             inhaler within three attempts at Visit 1.

          -  Males

          -  Females who are not pregnant or not planning a pregnancy during the study or not
             lactating.

          -  Informed Consent: Capable of giving signed and dated written informed consent which
             includes compliance with the requirements and restrictions listed in the consent form
             and in the protocol.

          -  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:

        A subject will not be eligible for inclusion in this study if any of the following criteria
        apply

          -  Asthma: Subjects with a current primary diagnosis of asthma.

          -  COPD medications: Receiving only inhaled short-acting beta-adrenergic agonists, i.e.,
             albuterol as their daily COPD therapy (as needed [prn] or regularly scheduled); Has
             changed maintenance COPD treatment within 4 weeks prior to Screening/Visit 1 or plans
             to change COPD treatment within 4 weeks of Visit 1.

          -  COPD/Exacerbations/Hospitalization: Subjects that have experienced a COPD exacerbation
             requiring systemic corticosteroids (oral, parenteral or depot) and/or antibiotics
             within four weeks of Visit 1. A subject must not have had any hospitalization for COPD
             within three months prior to Visit 1; Subjects with uncontrolled COPD, in the
             investigator's judgment that would affect subject's ability to evaluate "ease of use
             and correct use".

          -  Other Respiratory Disorders: Subjects with other respiratory disorders, including
             active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis,
             pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.

          -  Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior
             to Screening/Visit 1.

          -  Oxygen: Use of long-term oxygen therapy (LTOT; defined as oxygen therapy prescribed
             for greater than 12 hours per day) or nocturnal oxygen.

          -  Other Disease Abnormalities: 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; 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.

          -  Alcohol and Drug Abuse: A known or suspected history of alcohol or drug abuse within
             the last 2 years.

          -  A history of hypersensitivity to any components of the study inhaler (e.g., lactose,
             magnesium stearate). In addition, patients with a history of severe milk protein
             allergy that, in the opinion of the study physician, contraindicates participation
             will also be excluded.

          -  Prior or Ongoing use of the ELLIPTA inhaler (including both investigational and
             commercially available product).

          -  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.