An Open-label Study to Evaluate Correct Use and Ease of Use of the ELLIPTA DPI in Pediatric Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Placebo DPI; ELLIPTA DPI; Ease of use questionnaires
Intervention description: Subjects will receive placebo via oral inhalation route using ELLIPTA once daily. Placebo DPI will be available in two strips of 30 blisters per strip. First strip will contain lactose monohydrate and second strip will have lactose monohydrate blended with magnesium stearate.; Subjects will receive placebo DPI via ELLIPTA. ELLIPTA is trademark of GSK; Subjects from both stratum after use of ELLIPTA DPI will be randomized to receive either version A or B of the questionnaires. Subjects will be asked questions on ease of use of ELLIPTA. Parent/guardian will also complete a questionnaire about the ELLIPTA DPI.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Subjects from the age group of 5 to 11 years with documented history of symptoms of asthma or diagnosis of asthma for at least 6 months prior to Visit 1 will be assessed for the ease of use of ELLIPTA DPI.
Masking: None (Open Label)
Enrollment: 222.0
Sex: All
Minimum age: 5 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Asthma; Dry Powder Inhaler; Metered Dose Inhaler; Long Acting beta 2 Agonist; ELLIPTA

Summary:

      Asthma is a chronic inflammatory disease of airways and lungs that results in
      hyper-reactivity and clinically relevant episodes of wheezing. This study has been designed
      to assess the correct use and ease of use of the ELLIPTA® DPI in pediatric subjects with
      asthma. ELLIPTA DPI is easy to use, requires few steps, is consistent in dosing and
      eliminates the hand-breath co-ordination required for metered dose inhalers (MDIs). Subjects
      will be stratified by age into two strata: Stratum 1: subjects in the age group of 5 to 7
      years and Stratum 2: Subjects in the age group of 8 to 11 years. All subjects will be trained
      by Health care professionals (HCP) for the correct use of ELLIPTA DPI. Subjects will be given
      three chances to attempt correct use of ELLIPTA DPI; subsequently, if the subject is not
      successful, the parent/guardian will be able to help instruct the subject on the correct use
      of the ELLIPTA DPI, for two more attempts. The subjects who will be enrolled in the study
      will take placebo ELLIPTA DPI once daily. After 28 days subjects will be randomized in 1:1 to
      receive a questionnaire (Version A and B). After completion of the questionnaire on ELLIPTA
      DPI ease of use, subject's ability to use ELLIPTA DPI correctly will be re-assessed.
      Approximately 219 subjects will be screened to participate in the study. The study will be
      conducted for 28 days. ELLIPTA is a registered trademark of GlaxoSmithKline (GSK) group of
      companies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects between 5 and 11 years old (inclusive), at the time of the Visit 0.

          -  Subjects with a documented history of symptoms consistent with a diagnosis of asthma
             for at least 6 months prior to V0 (includes asthma diagnosis).

          -  Males and premenarchial females.

          -  Written informed consent from at least one parent/guardian and the accompanying
             informed assent from the subject (where the subject is able to provide assent) prior
             to admission to the study.

          -  Subject and their legal guardian understand and are willing, able, and likely to
             comply with study procedures and assessments.

          -  Subject must have been receiving asthma treatment (rescue or maintenance) for 3 months
             prior to entry onto the study.

          -  Subject must have never been trained in correct use of, or used the ELLIPTA DPI
             previously.

          -  Subjects must be able to demonstrate correct use of the ELLIPTA DPI after
             coaching/training at Visit 1.

          -  Subjects must be able to converse and understand verbal instruction in English.

        Exclusion Criteria:

          -  Subjects with concurrent diagnosis of other respiratory disorders including active
             tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary
             hypertension, interstitial lung diseases, cystic fibrosis or other active pulmonary
             diseases.

          -  Subjects with concurrent diagnosis of psychiatric or psychological or any other
             disorders that in the opinion of the investigator may affect the ability of the
             subject to comply with study procedures or requirements.

          -  Subject has experienced an exacerbation which required oral/systemic corticosteroids
             in the three months prior to Visit 0.

          -  Subject has been hospitalized for an episode of asthma within three months of Visit 0.

          -  Subject has had an asthmatic episode requiring intubation, associated with
             hypercapnia, respiratory arrest or hypoxic seizures.

          -  Subject has exhibited symptoms of a recent acute respiratory tract infection within
             one week of Visit 0.

          -  Subject has history of hypersensitivity to any components of the study inhalers
             (example [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 will also be excluded.

          -  Subjects with historical or current evidence of clinically significant or rapidly
             progressing or unstable cardiovascular, neurological, renal, hepatic, immunological,
             endocrine (including 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 analysis if the disease/condition exacerbated during the study.

          -  Parent or Guardian with a history of psychiatric disease, intellectual deficiency,
             substance abuse or other condition (e.g. inability to read, comprehend or write) which
             may affect: Validity of consent to participate in the study; Adequate supervision of
             the subject during the study; Compliance of subject with study medication and study
             procedures; subject safety and well-being.

          -  Subjects who have received an investigational drug and/or medical device within 30
             days of entry into this study (Screening), 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.