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

ID: NCT03114969
Status: Recruiting
Phase: N/A
Start Date: June 08, 2017
First Submitted: April 11, 2017
Last Updated: February 22, 2018
Results: N/A
Organization: GlaxoSmithKline
Sponsors & Collaborators: GlaxoSmithKline
Location: Netherlands, United Kingdom
Conditions: Pulmonary Disease, Chronic Obstructive
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Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Pulmonary Disease, Chronic Obstructive

Device: ELLIPTA Inhaler
Other Names
Device: TURBUHALER
Other Names
Device: DISKUS Inhaler
Other Names
Device: HANDIHALER
Other Names
Device: BREEZHALER
Other Names
N/A

Tracking Information

First Submitted DateApril 11, 2017
Last Update Posted DateFebruary 22, 2018
Actual Start DateJune 08, 2017
Anticipated Completion DateApril 24, 2018
Actual Primary Completion DateApril 24, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Percentage of subjects making at least one critical error at Visit 1 for each DPI tested [Time Frame: Day 1]

    Subjects making any critical error in the use of the DPI prior to any training in correct use from a Healthcare Professional (HCP) will be recorded on the checklists. A critical error is defined as an error that is most likely to result in no or significantly reduced medication being inhaled.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Percentage of subjects making at least one overall error at Visit 1 for each DPI tested [Time Frame: Day 1]

    Subjects making an overall error (the combination of all errors 'critical' or 'non-critical') prior to any retraining in correct use from a Healthcare Professional (HCP) will be recorded on the checklists. A non critical error is defined as one where the dose may not be affected, but the subject has demonstrated improper use of their DPI as per the Patient Information leaflet.

  • Percentage of subjects making at least one critical error at Visit 2 for each DPI tested [Time Frame: Up to 7 weeks]

    Subjects making any critical error in the use of the DPI prior to any training in correct use from a Healthcare Professional (HCP) at Visit 2 will be recorded on the checklists. If the subject cannot demonstrate correct use at this visit, they will be referred to their General Practitioner (GP) for further training.

  • Percentage of subjects making at least one overall error at Visit 2 for each DPI tested [Time Frame: Up to 7 weeks]

    Subjects making an overall error (the combination of all errors 'critical' or 'non-critical') prior to any retraining in correct use from a Healthcare Professional (HCP) at Visit 2 will be recorded on the checklists. If the subject cannot demonstrate correct use at this visit, they will be referred to their General Practitioner (GP) for further training.

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleComparative Study of Error Rates Between ELLIPTA® Dry Powder Inhaler (DPI) and Other DPIs
Official TitleAn 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)
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.

Detailed Description

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
450
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Pulmonary Disease, Chronic Obstructive
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodNon-Probability Sample
Study PopulationSubjects with chronic obstructive pulmonary disease and uses a dry powder inhaler
Intervention
Device: ELLIPTA Inhaler

ELLIPTA inhaler will be used by subjects as their primary treatment to control COPD.

Other Names
Device: TURBUHALER

TURBUHALER inhaler will be used by subjects as their primary treatment to control COPD.

Other Names
Device: DISKUS Inhaler

DISKUS inhaler will be used by subjects as their primary treatment to control COPD.

Other Names
Device: HANDIHALER

HANDIHALER inhaler will be used by subjects as their primary treatment to control COPD.

Other Names
Device: BREEZHALER

BREEZHALER inhaler will be used by subjects as their primary treatment to control COPD.

Other Names
Study Groups/Cohorts
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.

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.

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.

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.

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.

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.

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.

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.

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.

Study Arms
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 : ELLIPTA Inhaler
ELLIPTA inhaler will be used by subjects as their primary treatment to control COPD.

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 : DISKUS Inhaler
DISKUS inhaler will be used by subjects as their primary treatment to control COPD.

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 : HANDIHALER
HANDIHALER inhaler will be used by subjects as their primary treatment to control COPD.

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 : ELLIPTA Inhaler
ELLIPTA inhaler will be used by subjects as their primary treatment to control COPD.

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 : ELLIPTA Inhaler
ELLIPTA inhaler will be used by subjects as their primary treatment to control COPD.

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 : HANDIHALER
HANDIHALER inhaler will be used by subjects as their primary treatment to control COPD.

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 : ELLIPTA Inhaler
ELLIPTA inhaler will be used by subjects as their primary treatment to control COPD.

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
BREEZHALER inhaler will be used by subjects as their primary treatment to control COPD.

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 : DISKUS Inhaler
DISKUS inhaler will be used by subjects as their primary treatment to control COPD.

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 : HANDIHALER
HANDIHALER inhaler will be used by subjects as their primary treatment to control COPD.

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 : TURBUHALER
TURBUHALER inhaler will be used by subjects as their primary treatment to control COPD.

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 : TURBUHALER
TURBUHALER inhaler will be used by subjects as their primary treatment to control COPD.

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 : ELLIPTA Inhaler
ELLIPTA inhaler will be used by subjects as their primary treatment to control COPD.

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 : HANDIHALER
HANDIHALER inhaler will be used by subjects as their primary treatment to control COPD.

Arm Intervention/Treatment
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 : ELLIPTA Inhaler
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 : DISKUS Inhaler
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 : 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 : ELLIPTA Inhaler
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 : ELLIPTA Inhaler
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 : HANDIHALER
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 : ELLIPTA Inhaler
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 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 : DISKUS Inhaler
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 : HANDIHALER
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 : TURBUHALER
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 : TURBUHALER
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 : ELLIPTA Inhaler
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 : HANDIHALER

Recruitment Information

Recruitment Status:Recruiting
Enrollment450
Completion DateApril 24, 2018
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.
GenderAll
Age40 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Netherlands
United Kingdom

Administrative Information

NCT Number:NCT03114969
Other Study ID Numbers
204981
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
GlaxoSmithKline
Collaborators
Not Available
Investigators
Study Director
GSK Clinical Trials
GlaxoSmithKline