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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Device: BREEZHALER; Device: Anoro ELLIPTA; Device: Relvar ELLIPTA; Device: Incruse ELLIPTA; Device: Symbicort TURBUHALER; Device: Spiriva HANDIHALER; Device: Seretide DISKUS

Study type: Observational

Funder types: Industry

Identifiers

NCT03114969

204981

Details and patient eligibility

About

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.

Enrollment: 450 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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 design

450 participants in 9 patient groups

Subjects using RELVAR ELLIPTA

Description:

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.

Treatment:

Device: Relvar ELLIPTA

Subjects using SYMBICORT TURBUHALER

Description:

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

Treatment:

Device: Symbicort TURBUHALER

Subjects using SERETIDE DISKUS

Description:

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

Treatment:

Device: Seretide DISKUS

Subjects using SPIRIVA HANDIHALER

Description:

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.

Treatment:

Device: Spiriva HANDIHALER

Subjects using INCRUSE ELLIPTA or ANORO ELLIPTA

Description:

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.

Treatment:

Device: Anoro ELLIPTA

Device: Incruse ELLIPTA

Subjects using SEEBRI BREEZHALER or ULTIBRO BREEZHALER

Description:

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.

Treatment:

Device: BREEZHALER

Subjects using RELVAR ELLIPTA with HANDIHALER/ INCRUSE ELLIPTA

Description:

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.

Treatment:

Device: Spiriva HANDIHALER

Device: Incruse ELLIPTA

Device: Relvar ELLIPTA

Subjects using TURBUHALER with HANDIHALER/INCRUSE ELLIPTA

Description:

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.

Treatment:

Device: Spiriva HANDIHALER

Device: Incruse ELLIPTA

Device: Symbicort TURBUHALER

Subjects using DISKUS with HANDIHALER/INCRUSE ELLIPTA

Description:

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.

Treatment:

Device: Spiriva HANDIHALER

Device: Seretide DISKUS

Device: Incruse ELLIPTA