A Comparison of Critical Errors, Overall Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA Versus BREEZHALER Dry Powder Inhalers (DPIs) in Adult Participants With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: ELLIPTA; BREEZHALER
Intervention description: ELLIPTA followed by BREEZHALER/ Preference Questionnaire version 1
ELLIPTA followed by BREEZHALER/ Preference Questionnaire version 2
BREEZHALER followed by ELLIPTA/ Preference Questionnaire version 1
BREEZHALER followed by ELLIPTA/ Preference Questionnaire version 2; ELLIPTA followed by BREEZHALER/ Preference Questionnaire version 1
ELLIPTA followed by BREEZHALER/ Preference Questionnaire version 2
BREEZHALER followed by ELLIPTA/ Preference Questionnaire version 1
BREEZHALER followed by ELLIPTA/ Preference Questionnaire version 2
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study will be a randomized, multi-center, open label, placebo- controlled device handling study.
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ELLIPTA; BREEZHALER; Dry powder inhaler; Asthma

Summary:

      This study aims to provide data in adult participants with mild to moderate asthma to assist
      healthcare professionals (HCPs) in assessing various attributes of ELLIPTA and BREEZHALER
      DPIs, by comparing the incidence of critical and overall errors, participant preference,
      willingness to continue with the inhaler and time to correct use. ELLIPTA® is a registered
      trademark of GlaxoSmithKline (GSK) and BREEZHALER® is a registered trademark of Novartis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be aged 18 years or older at the time of signing the informed
             consent.

          -  Participants who have a confirmed mild or moderate asthma diagnosis as per Global
             Initiative for Asthma (GINA), 2020.

          -  Participants must be on asthma maintenance therapy (Inhaled corticosteroids [ICS] or
             ICS/ Long acting beta 2-agonist [LABA]) for at least 12 weeks prior to study
             participation.

          -  Participants must be naïve to both the ELLIPTA and BREEZHALER inhalers.

          -  Females who are not pregnant or not planning a pregnancy during the study or not
             Lactating.

          -  Capable of giving signed informed consent which includes compliance with the
             requirements and restrictions listed in the informed consent form (ICF) and in this
             protocol.

        Exclusion Criteria:

          -  Concurrent diagnosis of chronic obstructive pulmonary disease (COPD) or other
             respiratory disorders.

          -  History of hypersensitivity to any components of the study inhaler (e.g., lactose). In
             addition, participants with a history of severe milk protein allergy that, in the
             opinion of the study physician, contraindicates participation will also be excluded.

          -  Historical or current evidence of clinically significant or rapidly progressing or
             unstable 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.

          -  Drug/alcohol abuse: Participants with a known or suspected alcohol or drug abuse,
             which in the opinion of the investigator could interfere with the participant's proper
             completion of the protocol requirement.

          -  A participant 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, as well as employees of GSK or Novartis.

          -  Inability to Read: In the opinion of the investigator, any participant who is unable
             to read and/or would not be able to complete a questionnaire and understand verbal
             instructions.

          -  Medical and physical conditions that in the opinion of the investigator could impact
             the ability of the participant to manipulate the inhaler.