Phase 4
Completed N=567
Study of Inhaler Device Attributes Investigating Critical and Overall Errors, Ease of Use, and Preference Between a Number of Inhaler Devices
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT02184624 ↗
Enrolled (actual)
567
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet — 2; 4; 1; 4 Percentage of participants — p=<0.001
◆ Published Evidence
Established
97citations · ~10 / year
A randomised open-label cross-over study of inhaler errors, preference and time to achieve correct inhaler use in patients with COPD or asthma: comparison of ELLIPTA with other inhaler devices.
Summary
This is a randomised, open-label, placebo, crossover, multicentre study with a single visit. The study will comprise five sub-studies. Subjects will receive inactive treatment (placebo) via the ELLIPTA® inhaler and one of the other inhaler devices depending on the sub-study they are randomised to. Only subjects who are naïve to the ELLIPTA inhaler and to one of the other inhaler devices that will be used in this study will be included. Furthermore, subjects who are naïve to the BREEZEHALER® and HANDIHALER® inhalers must be naïve to all other inhaler devices that requires a capsule. The study will be conducted in the UK and the Netherlands, and comprises one visit only. A sufficient number of subjects (at least 600) with COPD will be screened and 570 will be randomised to one of five sub-studies. Eligible subjects will be allocated to one of the sub-studies depending on their experience of using the other inhaler (i.e., depending on which other inhaler they are naïve to).
This study is designed to assess the proportion of COPD subjects making critical and overall (i.e., critical and non-critical errors) errors in using ELLIPTA inhaler and other commercially available inhaler devices such as the TURBUHALER®, HANDIHALER, BREEZHALER, MDI and DISKUS®/ACCUHALER® inhalers. This study will also assess the 'ease of use' and preference between the ELLIPTA inhaler and the other commercially available inhaler devices.
ELLIPTA, DISKUS, and ACCUHALER are registered trademarks of the GSK group of companies. TURBUHALER is a registered trademark of AstraZeneca. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG. BREEZHALER is a registered trademark of Novartis AG.
Linked Publications
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A randomised open-label cross-over study of inhaler errors, preference and time to achieve correct inhaler use in patients with COPD or asthma: comparison of ELLIPTA with other inhaler devices.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet |
2; 4; 1; 4; 8; 40 | <0.001 sig |
| SECONDARY Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet |
10; 1; 5; 10; 8; 45 | <0.001 sig |
| SECONDARY Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP |
0.6; 4; 0; 0; 1; 2 | 0.480 |
| SECONDARY Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP |
0.6; 3; 2; 3; 2; 12 | <0.001 sig |
| SECONDARY Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique |
119; 55; 69; 67; 68; 59 | <0.001 sig |
| SECONDARY Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire |
74; 75; 86; 87; 72; 11 | <0.001 sig |
| SECONDARY Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire |
66; 66; 72; 78; 65; 5 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Informed consent: Subject must give their signed and dated written informed consent to participate in the study; 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 Dutch and/or English.
- Age: >=40 years of age
- Gender: Male or female subjects.
- Primary diagnosis of COPD: subjects with a clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society. Comorbidities (rheumatoid arthritis or other locomotor problems, visual impairment, and depression or anxiety) will be documented as relevant to inhaler use.
- COPD treatment: All patients should be currently receiving treatment for COPD.
- Must be naïve to using ELLIPTA inhaler and at least one other inhaler device. Subjects who are naïve to the BREEZEHALER and HANDIHALER inhalers must be naïve to all other inhaler devices that requires a capsule.
Exclusion Criteria
- Asthma: Subjects with a current diagnosis of asthma only. Note: Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD.
- Contraindications: A history of allergy or hypersensitivity to lactose/milk protein or magnesium stearate or to any other excipient.
- Subjects who are currently participating in another randomised pharmacological interventional trial.
- Inability to Read: In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a questionnaire and understand verbal instructions.
Data sourced from ClinicalTrials.gov (NCT02184624) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.