Phase IV Study in Asthma Subjects for Dry Powder Inhaler (DPI) Versus (vs) Metered Dose Inhaler (MDI) Correct Use
Condition: Asthma
MeSH terms: Asthma
Intervention: ELLIPTA DPI; GSK MDI; AZ MDI
Intervention description: It is the inhaler with two blister strips containing white coloured powder, one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. It is given as oral inhalation (Inhalation powder); It is the placebo inhaler with clear liquid containing propellant (1,1,1, 2- Tetrafluoroethane). It is given as oral inhalation (Inhalation Aerosol).; It is the placebo inhaler with clear liquid. It is given as oral inhalation (Inhalation Aerosol).
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 324.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ELLIPTA; metered dose inhaler; Dry powder inhaler

Summary:

      The study is conducted to evaluate the potentially improved patient handling of the ELLIPTA
      Dry Powder Inhaler (DPI). Therefore, the study aims to evaluate errors encountered by subject
      with asthma during handling ELLIPTA DPI relative to two metered dose inhalers (MDI), a GSK
      MDI and the AstraZeneca (AZ) MDI. It is a randomised, multi-centre, open-label, cross-over
      study comparing placebo ELLIPTA DPI with placebo MDI (GSK and AZ) to assess correct inhaler
      use. No active drug will be used in this study in order to prevent any drug-related effects.
      Approximately, 152 subjects will be randomized to receive ELLIPTA DPI inhaler and 152 will be
      randomized to receive one of the MDI inhalers, for use during the first period (P)
      (approximately 28 days). At Visit 2 (Day 28) all subjects previous receiving the ELLIPTA DPI
      will be randomized to receive one of the MDI inhalers and all subjects who received a MDI in
      the previous period will receive the ELLIPTA DPI for use during second period (approximately
      28 days). Subjects will continue taking their asthma maintenance treatment and limited rescue
      albuterol MDI during the entire 56-day study period.

      ELLIPTA is a registered trademark of the GSK group of companies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  - Subjects aged 18 years or older, at the time of signing the informed consent

          -  Documented history of moderate persistent asthma

          -  Asthma Control Test (ACT) score >=20

          -  Male or Females (who are not pregnant or planning pregnancy during the study or not
             lactating)

          -  Capable of giving signed informed consent which includes compliance with the
             requirements and restrictions

          -  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

          -  Should not have received maintenance therapy via MDI or ELLIPTA in the past six months
             (DISKUS (trade name owned by GSK group of companies under license), TWISTHALER (trade
             name owned by Merck Sharp & Dohme Corporation, a subsidiary of Merck & Co, under
             license, etc are acceptable). Subject must be on maintenance therapy for 3 months,
             have not changed dose in the month prior to inclusion and be able to continue using
             their maintenance therapy throughout the study

          -  Requires Short-acting-beta-agonist (SABA) for symptom control =<2 days/week. Use of
             SABA prior to exercise for the prevention of exercise induced bronchoconstriction is
             exclusionary.

        Exclusion Criteria:

          -  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

          -  Current smokers or subjects with a smoking history of 10 pack-years or more (example,
             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)

          -  Concurrent diagnosis of chronic obstructive pulmonary disease (COPD) or other
             respiratory disorders including active tuberculosis, lung cancer, bronchiectasis,
             sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or
             other active pulmonary diseases

          -  History of life threatening asthma or has experienced more than 1 exacerbation which
             required oral/systemic corticosteroids in the 12 months prior to Visit 1

          -  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

          -  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
             hematological 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 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

          -  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.