A Randomized, Multi-center, Open-label, Cross-over Study Comparing Critical Errors, Overall Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA Dry Powder Inhaler Versus the BREEZHALER Dry Powder Inhaler, in Adult Participants With Mild to Moderate Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 3
- 主要终点
- Percentage of Participants Making at Least One Critical Error After Reading the Patient Information Leaflets (PIL)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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),
- •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.
排除标准
- •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.
研究组 & 干预措施
ELLIPTA/ BREEZHALER/Questionnaire version 1
Participants received placebo ELLIPTA Dry Powder Inhaler (DPI) followed by placebo BREEZHALER DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and visual analogue scale (VAS) on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 1 on Day 1.
干预措施: ELLIPTA (Device)
ELLIPTA/ BREEZHALER/Questionnaire version 1
Participants received placebo ELLIPTA Dry Powder Inhaler (DPI) followed by placebo BREEZHALER DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and visual analogue scale (VAS) on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 1 on Day 1.
干预措施: BREEZHALER (Device)
ELLIPTA/ BREEZHALER/Questionnaire version 2
Participants received placebo ELLIPTA DPI followed by placebo BREEZHALER DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 2 on Day 1.
干预措施: ELLIPTA (Device)
ELLIPTA/ BREEZHALER/Questionnaire version 2
Participants received placebo ELLIPTA DPI followed by placebo BREEZHALER DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 2 on Day 1.
干预措施: BREEZHALER (Device)
BREEZHALER/ ELLIPTA/Questionnaire version 1
Participants received placebo BREEZHALER DPI followed by placebo ELLIPTA DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 1 on Day 1.
干预措施: ELLIPTA (Device)
BREEZHALER/ ELLIPTA/Questionnaire version 1
Participants received placebo BREEZHALER DPI followed by placebo ELLIPTA DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 1 on Day 1.
干预措施: BREEZHALER (Device)
BREEZHALER/ ELLIPTA/Questionnaire version 2
Participants received placebo BREEZHALER DPI followed by placebo ELLIPTA DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 2 on Day 1.
干预措施: ELLIPTA (Device)
BREEZHALER/ ELLIPTA/Questionnaire version 2
Participants received placebo BREEZHALER DPI followed by placebo ELLIPTA DPI on Day 1. Participants were asked to complete the ease-of-use questionnaire and VAS on their willingness to continue with the inhaler after using each device. Participants also completed the preference questionnaire version 2 on Day 1.
干预措施: BREEZHALER (Device)
结局指标
主要结局
Percentage of Participants Making at Least One Critical Error After Reading the Patient Information Leaflets (PIL)
时间窗: Day 1
Participants were asked to demonstrate use of their prescribed DPI on Day 1 and any error made by the participant was recorded by the health care practitioner (HCP) in the checklist. Checklist of instructions for correct use were based on the steps for correct use listed in PILs for the respective DPI. The errors made during demonstration by participants were defined as "critical" when an error was most likely to result in no or significantly reduced medication being inhaled. Percentage values are rounded off.
次要结局
- Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Easy' and 'Difficult')(Day 1)
- Time Taken to Demonstrate Inhaler Use After Reading PIL Without HCP Intervention (T1)(Day 1)
- Time Taken to Give Instructions by HCP on the Use of Inhaler and to Demonstrate the Correct Inhaler Use (T2)(Day 1)
- Total Time Taken for Demonstration of Correct Use After Reading PIL (T1+T2)(Day 1)
- Number of Participants Assessed for Ease-of-use of ELLIPTA Inhaler and BREEZHALER Inhaler Using Questionnaire (Grouped as 'Very Easy', 'Easy', 'Neutral', 'Difficult' and 'Very Difficult')(Day 1)
- Percentage of Participants Making at Least One Critical Error After Receiving Further Instructions (up to 3) From HCP(Day 1)
- Percentage of Participants Making at Least One Overall Error After Reading PIL(Day 1)
- Percentage of Participants Making at Least One Overall Error After Receiving Further Instructions (up to 3) From the HCP(Day 1)
- Number of Participants With Inhaler Preferences Assessed Using Preference Questionnaire(Day 1)
- Visual Analogue Scale (VAS) for the Assessment of Participants Willingness to Continue With the Inhaler(Day 1)
- Number of Critical and Overall Errors Made by Participants After Reading PIL and After Receiving Further Instructions (up to 3) From HCP(Day 1)
- Percentage of Participants Who Required Further Instruction (up to 3) From HCP to Demonstrate Correct Inhaler Use(Day 1)