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

NCT03114969 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2020-10-28

Study results available
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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

Interventions

DEVICE

Relvar ELLIPTA

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

DEVICE

Symbicort TURBUHALER

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

DEVICE

Seretide DISKUS

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

DEVICE

Spiriva HANDIHALER

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

DEVICE

BREEZHALER

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

DEVICE

Incruse ELLIPTA

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

DEVICE

Anoro ELLIPTA

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-08
Primary Completion
2018-03-09
Completion
2018-03-09

Countries

  • Netherlands
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03114969 on ClinicalTrials.gov