N/A
Completed N=450
Comparative Study of Error Rates Between ELLIPTA® Dry Powder Inhaler (DPI) and Other DPIs
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT03114969 ↗
Enrolled (actual)
450
Serious AEs
0.7%
Results posted
Jun 2019
Primary outcomePrimary: Percentage of Participants Making at Least One Critical Error at Visit 1-Primary Device Comparisons — 10; 40; 26; 34 Percentage of participants — p=0.005
Summary
For effective drug delivery using inhalation route, it is important to use the inhalers correctly. This open-label study will evaluate the error rates during the use of ELLIPTA DPI, alone or in combination, in comparison with other DPIs. The study aims to provide clinical evidence in subjects with COPD that the reduced number of steps required to use the ELLIPTA DPI could result in fewer errors made by subjects, and therefore a more consistent treatment. Approximately 450 subjects prescribed with either of RELVAR® ELLIPTA, ANORO® ELLIPTA, INCRUSE® ELLIPTA, SYMBICORT® TURBUHALER®, SERETIDE® DISKUS®, SPIRIVA® HANDIHALER®, ULTIBRO® BREEZHALER® or SEEBRI® BREEZHALER will be included in the study and will have 2 clinical visits. At Visit 1, subjects will take their maintenance DPIs and the critical and overall errors made by subjects will be assessed. After the assessment, subjects will be instructed on correct use or informed of their correct use of their DPIs. The total duration of the study is approximately 6 weeks. ELLIPTA, SERETIDE and DISKUS are registered trademarks of the GSK group of companies. SYMBICORT and TURBUHALER are registered trademarks of the AstraZeneca group of companies. SPIRIVA and HANDIHALER are registered trademarks of Boehringer Ingelheim Pharmaceuticals. ULTIBRO, BREEZHALER and SEEBRI are registered trademarks of the Novartis group of companies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Making at Least One Critical Error at Visit 1-Primary Device Comparisons |
10; 40; 26; 34; 10; 33 | 0.005 sig |
| PRIMARY Percentage of Participants Making at Least One Critical Error at Visit 1 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) |
25; 10 | 0.100 |
| PRIMARY Percentage of Participants Making at Least One Critical Error at Visit 1 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI |
11; 39; 26 | <0.001 sig |
| PRIMARY Percentage of Participants Making at Least One Critical Error at Visit 1-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA) |
10; 22 | 0.108 |
| PRIMARY Percentage of Participants Making at Least One Critical Error at Visit 1-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) |
10; 41 | 0.001 sig |
| PRIMARY Percentage of Participants Making at Least One Critical Error at Visit 1-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI) |
16; 47; 36 | <0.001 sig |
| SECONDARY Percentage of Participants Making at Least One Overall Error at Visit 1-Primary Device Comparisons |
34; 64; 60; 74; 37; 55 | 0.045 sig |
| SECONDARY Percentage of Participants Making at Least One Overall Error at Visit 1 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) |
57; 34 | 0.067 |
| SECONDARY Percentage of Participants Making at Least One Overall Error at Visit 1 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI |
34; 67; 63 | 0.008 sig |
| SECONDARY Percentage of Participants Making at Least One Overall Error at Visit 1-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA) |
34; 46 | 0.120 |
| SECONDARY Percentage of Participants Making at Least One Overall Error at Visit 1-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) |
34; 71 | <0.001 sig |
| SECONDARY Percentage of Participants Making at Least One Overall Error at Visit 1-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI) |
40; 72; 74 | 0.007 sig |
| SECONDARY Percentage of Participants Making at Least One Critical Error at Visit 2-Primary Device Comparisons |
0; 8; 11; 21; 0; 17 | 0.176 |
| SECONDARY Percentage of Participants Making at Least One Critical Error at Visit 2 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) |
8; 0 | 0.147 |
| SECONDARY Percentage of Participants Making at Least One Critical Error at Visit 2 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI |
3; 7; 12 | 0.395 |
| SECONDARY Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA) |
0; 8 | 0.090 |
| SECONDARY Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) |
0; 13 | 0.079 |
| SECONDARY Percentage of Participants Making at Least One Critical Error at Visit 2-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI) |
4; 11; 13 | 0.239 |
| SECONDARY Percentage of Participants Making at Least One Overall Error at Visit 2-Primary Device Comparisons |
12; 35; 27; 36; 8; 32 | 0.020 sig |
| SECONDARY Percentage of Participants Making at Least One Overall Error at Visit 2 in Primary DPI (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) |
19; 12 | 0.404 |
| SECONDARY Percentage of Participants Making at Least One Overall Error at Visit 2 in Primary DPI (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI |
13; 25; 27 | 0.189 |
| SECONDARY Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus Relvar Ellipta With Any Other LAMA) |
12; 16 | 0.472 |
| SECONDARY Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta DPI Versus All ICS/LABA DPIs With a LAMA Second DPI) |
12; 29 | 0.052 |
| SECONDARY Percentage of Participants Making at Least One Overall Error at Visit 2-Dual Device Comparisons (Relvar Ellipta With or Without a LAMA DPI) Versus Any Other ICS/LABA DPI With or Without a LAMA DPI) |
14; 33; 34 | 0.024 sig |
Eligibility Criteria
Inclusion Criteria
- Subjects with documented Physician's diagnosis of COPD, and currently receiving maintenance therapy.
- Aged >=40 years of age at inclusion.
- Using one of the maintenance therapies of interest for at least 3 months prior to inclusion on the study.
- Males or females.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in the protocol.
Exclusion Criteria
- Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD.
- Drug/alcohol abuse: Subjects with a known or suspected alcohol or drug abuse history at screening (Visit 0) that in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirement.
- Investigational product: 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 half-lives of the investigational drug, whichever is longer.
- Investigational product: Subjects who have been trained during participation in any device study in the 6 months prior to entry into this study.
Data sourced from ClinicalTrials.gov (NCT03114969). 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.