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Preference Attributes of ELLIPTA Dry Powder Inhaler (DPI) and HANDIHALER DPI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT02786927 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2018-10-15

Study results available
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Summary

This is a Phase IV multi-center, randomized, open-label, cross-over, placebo study in subjects with Chronic Obstructive Pulmonary Disease (COPD) to compare inhaler-specific preference attributes of two inhalers - ELLIPTA dry powder inhaler (DPI) and the HANDIHALER DPI. The primary objective of this study is to evaluate whether more subjects with COPD prefer the ELLIPTA inhaler to the HANDIHALER DPI based on the number of steps needed to take medication.

All subjects will use the ELLIPTA inhaler and the HANDIHALER inhaler in the corresponding treatment periods based on the randomisation scheme, and at the end of 2 periods, complete the inhaler preference questionnaire. Subjects will self-administer the inhalation once daily for 5-9 days in each treatment period.

This study will be placebo-only, and neither inhaler will contain active treatment. Subjects will continue their current COPD medication(s) as prescribed, and will follow up with their regular physician for their COPD healthcare during the study.

Approximately 211 subjects will be enrolled in the study.

ELLIPTA is a trademark of the GlaxoSmithKline group of companies. HANDIHALER is a trademark of Boehringer Ingelheim International GmbH.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Placebo ELLIPTA device

Placebo ELLIPTA is a DPI device containing powder for inhalation, to be inhaled orally once daily for 5-9 days. It contains two strips with 30 blisters per strip - one strip contains lactose monohydrate whereas the other strip contains lactose monohydrate blended with magnesium stearate.

DRUG

Placebo capsules for use in HANDIHALER device

Placebo capsules contain lactose monohydrate in the form of powder for inhalation, to be used with the HANDIHALER inhaler as an oral inhalation once daily for 5-9 days.

OTHER

Inhaler Preference Questionnaire Version 1

Consists of 5 questions to assess subjects' preference of device attributes and dosing regimens. The two versions of the questionnaire ask the same questions, but differ in the ordering of inhalers in their responses.

OTHER

Inhaler Preference Questionnaire Version 2

Consists of 5 questions to assess subjects' preference of device attributes and dosing regimens. The two versions of the questionnaire ask the same questions, but differ in the ordering of inhalers in their responses.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-21
Primary Completion
2016-10-04
Completion
2016-10-04

Countries

  • United States

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 NCT02786927 on ClinicalTrials.gov