Comparative Study of Error Rates Between ELLIPTA® Dry Powder Inhaler (DPI) and Other DPIs

NCT03114969 | Completed Results

• 1 other identifier: 204981
• Study Type: observational
• Target: 450
• Locations: 2 countries
• Sites: 13

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Overall error; Error rate; Critical error; COPD; ELLIPTA; Dry powder inhaler

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants Making at Least One Critical Error at Visit 1-Primary Device Comparisons

  Participants were asked to demonstrate use of their prescribed DPI at Visit 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 patient instruction leaflets (PILs) for the respective DPI. The errors made during demonstration by participants were defined as "critical", when the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The analysis was performed on the Intent to Treat (ITT) Population which comprised of all enrolled participants who demonstrated use of their primary DPI.

  Day 1

• 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)

  Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the 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 the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and reporting and analysis plan (RAP).

  Day 1

• 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

  Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the 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 the participant received a lesser/no dose. The percentage of participants making at least one critical error in the primary DPI is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.

  Day 1

• 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)

  Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the 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 the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented.

  Day 1

• 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)

  Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the 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 the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta versus all ICS/LABA+LAMA DPIs; hence, the arms were combined as pre-specified in the protocol and RAP.

  Day 1

• 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)

  Participants were asked to demonstrate use of their prescribed DPI at Visit 1 and any error made by the participant was recorded by the 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 the participant received a lesser/no dose. The percentage of participants making at least one critical error in either one or both devices (where applicable) is presented. The aim of the analysis was to compare percentage of participants making at least one critical error with Ellipta and Ellipta+LAMA versus Turbuhaler and Turbuhaler+LAMA and Diskus and Diskus+LAMA; hence, the arms were combined as pre-specified in the protocol and RAP.

  Day 1

Secondary Outcomes (18)

• Percentage of Participants Making at Least One Overall Error at Visit 1-Primary Device Comparisons

  Day 1

• 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)

  Day 1

• 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

  Day 1

• 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)

  Day 1

• 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)

  Day 1

Study Arms (9)

Subjects using RELVAR ELLIPTA

Subjects with a fixed dose combination of inhaled corticosteroids/ long-acting beta agonists (ICS/LABA) via a single DPI of RELVAR ELLIPTA for treatment of COPD will be included.

Device: Relvar ELLIPTA

Subjects using SYMBICORT TURBUHALER

Subjects with a fixed dose combination of ICS/LABA via a single DPI of SYMBICORT TURBUHALER for treatment of COPD will be included.

Device: Symbicort TURBUHALER

Subjects using SERETIDE DISKUS

Subjects with a fixed dose combination of ICS/LABA via a single DPI of SERETIDE DISKUS for treatment of COPD will be included.

Device: Seretide DISKUS

Subjects using SPIRIVA HANDIHALER

Subjects with a fixed dose monotherapy of long-acting muscarinic antagonists (LAMA) via a single DPI of SPIRIVA HANDIHALER for treatment of COPD will be included.

Device: Spiriva HANDIHALER

Subjects using INCRUSE ELLIPTA or ANORO ELLIPTA

Subjects with a fixed dose monotherapy of LAMA via a single DPI of INCRUSE ELLIPTA or subjects taking a fixed dose combination of LAMA/LABA via a single DPI of ANORO ELLIPTA for treatment of COPD will be included.

Device: Incruse ELLIPTA; Device: Anoro ELLIPTA

Subjects using SEEBRI BREEZHALER or ULTIBRO BREEZHALER

Subjects with a fixed dose monotherapy of LAMA via a single DPI of SEEBRI BREEZHALER or subjects taking a fixed dose combination of LAMA/LABA via a single DPI of ULTIBRO BREEZHALER for treatment of COPD will be included.

Device: BREEZHALER

Subjects using RELVAR ELLIPTA with HANDIHALER/ INCRUSE ELLIPTA

Subjects with a fixed dose combination of ICS/LABA via RELVAR ELLIPTA along with a fixed dose of LAMA via SPIRIVA HANDIHALER or INCRUSE ELLIPTA will be included.

Device: Relvar ELLIPTA; Device: Spiriva HANDIHALER; Device: Incruse ELLIPTA

Subjects using TURBUHALER with HANDIHALER/INCRUSE ELLIPTA

Subjects with a fixed dose combination of ICS/LABA via SYMBICORT TURBUHALER along with a fixed dose of LAMA via SPIRIVA HANDIHALER or INCRUSE ELLIPTA will be included.

Device: Symbicort TURBUHALER; Device: Spiriva HANDIHALER; Device: Incruse ELLIPTA

Subjects using DISKUS with HANDIHALER/INCRUSE ELLIPTA

Subjects with a fixed dose combination of ICS/LABA via SERETIDE DISKUS along with a fixed dose of LAMA via SPIRIVA HANDIHALER or INCRUSE ELLIPTA will be included.

Device: Seretide DISKUS; Device: Spiriva HANDIHALER; Device: Incruse ELLIPTA

Interventions

Relvar ELLIPTA DEVICE

ELLIPTA inhaler containing Relvar will be used by subjects as their maintenance treatment to control COPD.

Subjects using RELVAR ELLIPTA; Subjects using RELVAR ELLIPTA with HANDIHALER/ INCRUSE ELLIPTA

Symbicort TURBUHALER DEVICE

TURBUHALER inhaler containing Symbicort will be used by subjects as their maintenance treatment to control COPD.

Subjects using SYMBICORT TURBUHALER; Subjects using TURBUHALER with HANDIHALER/INCRUSE ELLIPTA

Seretide DISKUS DEVICE

DISKUS inhaler containing Seretide will be used by subjects as their maintenance treatment to control COPD.

Subjects using DISKUS with HANDIHALER/INCRUSE ELLIPTA; Subjects using SERETIDE DISKUS

Spiriva HANDIHALER DEVICE

HANDIHALER inhaler containing Spiriva will be used by subjects as their maintenance treatment to control COPD.

Subjects using DISKUS with HANDIHALER/INCRUSE ELLIPTA; Subjects using RELVAR ELLIPTA with HANDIHALER/ INCRUSE ELLIPTA; Subjects using SPIRIVA HANDIHALER; Subjects using TURBUHALER with HANDIHALER/INCRUSE ELLIPTA

BREEZHALER DEVICE

BREEZHALER inhaler containing either Seebri or Ultibro will be used by subjects as their maintenance treatment to control COPD.

Subjects using SEEBRI BREEZHALER or ULTIBRO BREEZHALER

Incruse ELLIPTA DEVICE

ELLIPTA inhaler containing Incruse will be used by subjects as their maintenance treatment to control COPD.

Subjects using DISKUS with HANDIHALER/INCRUSE ELLIPTA; Subjects using INCRUSE ELLIPTA or ANORO ELLIPTA; Subjects using RELVAR ELLIPTA with HANDIHALER/ INCRUSE ELLIPTA; Subjects using TURBUHALER with HANDIHALER/INCRUSE ELLIPTA

Anoro ELLIPTA DEVICE

ELLIPTA inhaler containing Anoro will be used by subjects as their maintenance treatment to control COPD.

Subjects using INCRUSE ELLIPTA or ANORO ELLIPTA

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with chronic obstructive pulmonary disease and uses a dry powder inhaler

You may qualify if:

• Subjects with documented Physician's diagnosis of COPD, and currently receiving maintenance therapy.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (13)

GSK Investigational Site

Beek, 6191JW, Netherlands

Location

GSK Investigational Site

Beek en Donk, 5741 CG, Netherlands

Location

GSK Investigational Site

Eindhoven, 5623 EJ, Netherlands

Location

GSK Investigational Site

Hengelo, 7555 DL, Netherlands

Location

GSK Investigational Site

Hoorn, 1624 NP, Netherlands

Location

GSK Investigational Site

Kloosterhaar, 7694 AC, Netherlands

Location

GSK Investigational Site

Nijverdal, 7442 LS, Netherlands

Location

GSK Investigational Site

Rotterdam, 3051 GV, Netherlands

Location

GSK Investigational Site

Zutphen, 7207 AE, Netherlands

Location

GSK Investigational Site

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

GSK Investigational Site

London, EC1M 6BQ, United Kingdom

Location

GSK Investigational Site

London, SW17 0QT, United Kingdom

Location

GSK Investigational Site

Sidcup, Kent, DA14 6LT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32606640 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 14, 2017
• Study Start: June 8, 2017
• Primary Completion: March 9, 2018
• Study Completion: March 9, 2018
• Last Updated: October 28, 2020
• Results First Posted: June 10, 2019

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

NL (9); GB (4)