Last updated: 10/06/2020 14:50:06
Comparative study of error rates between ELLIPTA® dry powder inhaler (DPI) and other DPIs
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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)
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percentage of subjects making at least one critical error at Visit 1 for each DPI tested
Timeframe: Day 1
Secondary outcomes:
Percentage of subjects making at least one overall error at Visit 1 for each DPI tested
Timeframe: Day 1
Percentage of subjects making at least one critical error at Visit 2 for each DPI tested
Timeframe: Up to 7 weeks
Percentage of subjects making at least one overall error at Visit 2 for each DPI tested
Timeframe: Up to 7 weeks
Interventions:
Device: Relvar ELLIPTA
Device: Symbicort TURBUHALER
Device: Seretide DISKUS
Device: Spiriva HANDIHALER
Device: BREEZHALER
Device: Incruse ELLIPTA
Device: Anoro ELLIPTA
Enrollment:
450
Observational study model:
Cohort
Primary completion date:
2018-09-03
Time perspective:
Prospective
Clinical publications:
David Collier, Pascal Wielders, Job van der Palen, Logan Heyes, Dawn Midwinter, Kathryn Collison, Andy Preece, Neil Barnes, Raj Sharma. 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;15:1301-1313
DOI: 10.2147/COPD.S224209
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol/umeclidinium bromide, umeclidinium bromide, vilanterol
Collaborators
Not applicable
Study date(s)
June 2017 to March 2018
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Subjects with documented Physician’s diagnosis of COPD, and currently receiving maintenance therapy.
- Aged >=40 years of age at inclusion.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Northwood, Middlesex, United Kingdom, HA6 2RN
Status
Study Complete
Location
GSK Investigational Site
Sidcup, Kent, United Kingdom, DA14 6LT
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2018-09-03
Actual study completion date
2018-09-03
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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