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

Study Description

Brief Summary

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 Date	April 11, 2017
Last Update Posted Date	February 22, 2018
Actual Start Date	June 08, 2017
Anticipated Completion Date	April 24, 2018
Actual Primary Completion Date	April 24, 2018
Results First Submitted Date	N/A
Received Results Disposit Date	N/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

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

Study Design

Brief Title	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)
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 Type	Observational
Study Phase	N/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 Method	Non-Probability Sample
Study Population	Subjects 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 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.

Recruitment Information

Recruitment Status:	Recruiting
Enrollment	450
Completion Date	April 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.
Gender	All
Age	40 Years to N/A
Accepts Healthy Volunteers	No
Contacts	US GSK Clinical Trials Call Center 877-379-3718 [email protected]
Listed Location Countries	Netherlands United Kingdom

Administrative Information

NCT Number:	NCT03114969
Other Study ID Numbers	204981
Has Data Monitoring Committee	No
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