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

NCT ID: NCT03114969

Last Updated: 2020-10-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-08

Study Completion Date

2018-03-09

Brief Summary

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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

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Relvar ELLIPTA

Intervention Type DEVICE

ELLIPTA inhaler containing Relvar will be used by subjects as their maintenance 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.

Symbicort TURBUHALER

Intervention Type DEVICE

TURBUHALER inhaler containing Symbicort will be used by subjects as their maintenance 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.

Seretide DISKUS

Intervention Type DEVICE

DISKUS inhaler containing Seretide will be used by subjects as their maintenance 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.

Spiriva HANDIHALER

Intervention Type DEVICE

HANDIHALER inhaler containing Spiriva will be used by subjects as their maintenance 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.

Incruse ELLIPTA

Intervention Type DEVICE

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

Anoro ELLIPTA

Intervention Type DEVICE

ELLIPTA inhaler containing Anoro will be used by subjects as their maintenance 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.

BREEZHALER

Intervention Type DEVICE

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

Spiriva HANDIHALER

Intervention Type DEVICE

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

Incruse ELLIPTA

Intervention Type DEVICE

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

Relvar ELLIPTA

Intervention Type DEVICE

ELLIPTA inhaler containing Relvar will be used by subjects as their maintenance 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.

Spiriva HANDIHALER

Intervention Type DEVICE

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

Incruse ELLIPTA

Intervention Type DEVICE

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

Symbicort TURBUHALER

Intervention Type DEVICE

TURBUHALER inhaler containing Symbicort will be used by subjects as their maintenance 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.

Seretide DISKUS

Intervention Type DEVICE

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

Spiriva HANDIHALER

Intervention Type DEVICE

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

Incruse ELLIPTA

Intervention Type DEVICE

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

Interventions

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Seretide DISKUS

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

Intervention Type DEVICE

Spiriva HANDIHALER

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

Intervention Type DEVICE

BREEZHALER

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

Intervention Type DEVICE

Incruse ELLIPTA

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

Intervention Type DEVICE

Anoro ELLIPTA

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

Intervention Type DEVICE

Relvar ELLIPTA

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

Intervention Type DEVICE

Symbicort TURBUHALER

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Beek, , Netherlands

Site Status

GSK Investigational Site

Beek en Donk, , Netherlands

Site Status

GSK Investigational Site

Eindhoven, , Netherlands

Site Status

GSK Investigational Site

Hengelo, , Netherlands

Site Status

GSK Investigational Site

Hoorn, , Netherlands

Site Status

GSK Investigational Site

Kloosterhaar, , Netherlands

Site Status

GSK Investigational Site

Nijverdal, , Netherlands

Site Status

GSK Investigational Site

Rotterdam, , Netherlands

Site Status

GSK Investigational Site

Zutphen, , Netherlands

Site Status

GSK Investigational Site

Northwood, Middlesex, United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

GSK Investigational Site

Sidcup, Kent, , United Kingdom

Site Status

Countries

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Netherlands United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 32606640 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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204981

Identifier Type: -

Identifier Source: org_study_id