Study of the Ease of Use and Correct Use of Placebo ELLIPTA® Inhaler in Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Placebo ELLIPTA inhaler; Questionnaire
Intervention description: The ELLIPTA Dry Powder Inhaler (DPI) is a molded plastic two-sided inhaler that can hold two individual blister strips. Each strip will contain either lactose or a blend of lactose and magnesium stearate. 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: 259.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: correct use of inhaler; dose left; ease of use; ELLIPTA; Asthma

Summary:

      Asthma is a chronic disease of the lungs characterized by airway inflammation,
      bronchoconstriction and increased airway responsiveness. Inhaled corticosteroids (ICS), alone
      or in combination with inhaled long-acting beta-adrenergic agonists (LABA), are considered a
      mainstay of treatment for treatment. For inhaled medications, the choice of inhalation device
      is an important consideration because an inadequate technique reduces the delivery of
      medicines and effects of inhalation. Therefore, the development of an easy-to-use inhaler
      that delivers the drug to the lungs effectively, is important. This study is designed to
      assess the correct use of the ELLIPTA inhaler in subjects with asthma and also 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 asthma and receiving asthma
      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:

        A subject will be eligible for inclusion in this study only if all of the following
        criteria apply:

          -  Age: >=18 years of age at Screening at Visit 1

          -  Diagnosis: Asthma as defined by the National Institutes of Health

          -  Reversibility of Disease: Demonstrated historical reversibility of >=12% and >=200
             millilitre (mL) reversibility of Forced Expiratory Volume in One Second (FEV1) within
             10-40 minutes following 2-4 inhalations of albuterol inhalation aerosol (or equivalent
             nebulized treatment with albuterol solution) within 24 months of Visit 1

          -  Current asthma Therapy: Currently receiving maintenance (with one or more of the
             following therapies: e.g. inhaled corticosteroid alone or in combination with
             long-acting bronchodilators, such as long-acting beta 2-agonist [LABA]) inhaler
             therapy (with no prior or ongoing use of ELLIPTA inhaler) for the treatment of asthma.
             Subjects must be able to continue using their currently prescribed asthma maintenance
             inhaler therapy throughout the study and as needed short acting betaadrenergic 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.

          -  Capable of giving signed and dated written informed consent as described in protocol
             which includes compliance with the requirements and restrictions listed in the consent
             form and in this 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

          -  Chronic Obstructive Pulmonary Disease (COPD): Subjects with a current diagnosis of
             COPD.

          -  Asthma medications:

        Receiving only inhaled short-acting beta-adrenergic agonists, i.e., albuterol as their
        daily asthma therapy (as needed [prn] or regularly scheduled).

        Has changed maintenance asthma treatment within 4 weeks prior to Screening/Visit 1 or plans
        to change asthma treatment within 4 weeks of Visit 1.

          -  Asthma/Exacerbations/Hospitalization:

        Any asthma exacerbation, defined as deterioration of asthma requiring the use of systemic
        corticosteroids (oral, parenteral or depot) within 4 weeks of Visit 1. A subject must not
        have any hospitalisation or emergency department visit due to asthma within 3 months of
        Visit 1.

        Subjects with poorly controlled or who have unstable asthma, in the investigator's judgment
        that would affect subject's ability to evaluate "ease of use and correct use".

        History of life-threatening asthma, defined an asthma episode that required intubation
        and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.

          -  Other Respiratory Disorders: Subjects with other respiratory disorders, including
             active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis,
             pulmonary hypertension, or pulmonary disease (including, but not confined to chronic
             bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis,
             bronchopulmonary dysplasia, and chronic obstructive pulmonary disease), interstitial
             lung diseases or other active pulmonary diseases.

          -  Other Disease Abnormalities:

        Historical or current evidence of clinically significant or rapidly progressing or unstable
        cardiovascular, neurological, 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 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.

          -  Oropharyngeal Examination: Subjects with clinical visual evidence of oral candidiasis
             at Visit 1 are not eligible.

          -  Compliance: Subjects at risk of non-compliance, or unable to comply with the study
             procedures, or unable to continue their current asthma medications.

          -  Tobacco Use: Current smokers or subjects with a smoking history of 10 pack-years or
             more (e.g., 20 cigarettes/day for 10 years) are not eligible. A subject may not have
             used tobacco products within the past year (i.e., cigarettes, cigars, or pipe
             tobacco).

          -  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/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