Clinical trial NCT03114969: Comparative Study of Error Rates Between ELLIPTA® Dry Powder Inhaler (DPI) and Other DPIs
Official title: An Open-label, Low Interventional Clinical Study Investigating Error Rates (Critical and Overall) Prior to Any Retraining in Correct Use of the ELLIPTA Dry Powder Inhaler (DPI) Compared to Other DPIs Including; DISKUS, Turbuhaler, HandiHaler and Breezhaler as a Monotherapy or in Combination, in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Overall error
Error rate
Critical error
COPD
ELLIPTA
Dry powder inhaler
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-04-14
Enrollment: 450
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with chronic obstructive pulmonary disease and uses a dry powder inhaler

Brief 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.


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.

Primary outcomes:
measure: Percentage of Participants Making at Least One Critical Error at Visit 1-Primary Device Comparisons
timeFrame: Day 1
measure: 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)
timeFrame: Day 1
measure: 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
timeFrame: Day 1
measure: 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)
timeFrame: Day 1
measure: 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)
timeFrame: Day 1
measure: 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)
timeFrame: Day 1
Secondary outcomes:
measure: Percentage of Participants Making at Least One Overall Error at Visit 1-Primary Device Comparisons
timeFrame: Day 1
measure: 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)
timeFrame: Day 1
measure: 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
timeFrame: Day 1
measure: 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)
timeFrame: Day 1
measure: 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)
timeFrame: Day 1
measure: 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)
timeFrame: Day 1
measure: Percentage of Participants Making at Least One Critical Error at Visit 2-Primary Device Comparisons
timeFrame: Week 6
measure: 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)
timeFrame: Week 6
measure: 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
timeFrame: Week 6
measure: 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)
timeFrame: Week 6
measure: 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)
timeFrame: Week 6
measure: 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)
timeFrame: Week 6
measure: Percentage of Participants Making at Least One Overall Error at Visit 2-Primary Device Comparisons
timeFrame: Week 6
measure: 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)
timeFrame: Week 6
measure: 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
timeFrame: Week 6
measure: 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)
timeFrame: Week 6
measure: 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)
timeFrame: Week 6
measure: 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)
timeFrame: Week 6
Other outcomes:
Locations:
city: Beek En Donk
country: Netherlands
facility: GSK Investigational Site
city: Beek
country: Netherlands
facility: GSK Investigational Site
city: Eindhoven
country: Netherlands
facility: GSK Investigational Site
city: Hengelo
country: Netherlands
facility: GSK Investigational Site
city: Hoorn
country: Netherlands
facility: GSK Investigational Site
city: Kloosterhaar
country: Netherlands
facility: GSK Investigational Site
city: Nijverdal
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Zutphen
country: Netherlands
facility: GSK Investigational Site
city: Northwood
country: United Kingdom
facility: GSK Investigational Site
state: Middlesex
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Sidcup, Kent
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Collier DJ, Wielders P, van der Palen J, Heyes L, Midwinter D, Collison K, Preece A, Barnes N, Sharma R. Critical Error Frequency and the Impact of Training with Inhalers Commonly used for Maintenance Treatment in Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2020 Jun 9;15:1301-1313. doi: 10.2147/COPD.S224209. eCollection 2020.