A Randomized, Open-label, Cross-over, Placebo-device Study Investigating Critical and Over All Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA Dry Powder Inhaler (DPI) as Compared to HANDIHALER DPI Used in Combination With Either DISKUS DPI or TURBUHALER DPI, in Adult Patients With Chronic Obstructive Pulmonary Disease (COPD)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 160
- Locations
- 6
- Primary Endpoint
- Percentage of Participants Making at Least One Critical Error After Reading the Patient Information Leaflets (PIL)
Study Overview
Brief Summary
This is a randomized, multi-centre, open-label, placebo-device, cross-over study, with a 2x2 complete block design in subjects with chronic obstructive pulmonary disease (COPD) to assess the benefits of delivering triple therapy using a single ELLIPTA dry powder inhaler (DPI) (closed triple therapy) versus delivering triple therapy using two different types of DPI (open triple therapy). The primary objective of the study is to evaluate the proportion of COPD subjects who make critical errors when using a single ELLIPTA DPI versus those using combinations of DISKUS® with HANDIHALER®, or TURBUHALER® with HANDIHALER. At Visit 1, all subjects will demonstrate the use of ELLIPTA DPI, and HANDIHALER DPI in combination with either DISKUS DPI (in sub-study 1) or TURBUHALER DPI (in sub-study 2), based on the treatment sequences. At the end Visit 1, subjects will complete the inhaler preference questionnaire (PQ). There is no active treatment and subjects will continue to take their own prescribed COPD medication for the duration of the study. ELLIPTA and DISKUS are registered trademarks of the GSK group of companies; TURBUHALER is a registered trademark of AstraZeneca and HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ1
In this sequence, subjects will be randomized to use ELLIPTA inhaler in period 1 and then DISKUS + HANDIHALER in period 2. At the end of Visit 1, subjects will complete version 1 of the PQ (PQ1)
Intervention: Placebo ELLIPTA (Device)
Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ1
In this sequence, subjects will be randomized to use ELLIPTA inhaler in period 1 and then DISKUS + HANDIHALER in period 2. At the end of Visit 1, subjects will complete version 1 of the PQ (PQ1)
Intervention: Placebo DISKUS (Device)
Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ1
In this sequence, subjects will be randomized to use ELLIPTA inhaler in period 1 and then DISKUS + HANDIHALER in period 2. At the end of Visit 1, subjects will complete version 1 of the PQ (PQ1)
Intervention: Placebo HANDIHALER (Device)
Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ2
In this sequence, subjects will be randomized to use DISKUS + HANDIHALER in period 1 and then ELLIPTA in period 2. At the end of Visit 1, subjects will complete version 2 of the PQ (PQ2)
Intervention: Placebo ELLIPTA (Device)
Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ2
In this sequence, subjects will be randomized to use DISKUS + HANDIHALER in period 1 and then ELLIPTA in period 2. At the end of Visit 1, subjects will complete version 2 of the PQ (PQ2)
Intervention: Placebo DISKUS (Device)
Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ2
In this sequence, subjects will be randomized to use DISKUS + HANDIHALER in period 1 and then ELLIPTA in period 2. At the end of Visit 1, subjects will complete version 2 of the PQ (PQ2)
Intervention: Placebo HANDIHALER (Device)
Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ2
In this sequence, subjects will be randomized to use DISKUS + HANDIHALER in period 1 and then ELLIPTA in period 2. At the end of Visit 1, subjects will complete version 2 of the PQ (PQ2)
Intervention: PQ2 (Other)
Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ2
In this sequence, subjects will be randomized to use ELLIPTA inhaler in period 1 and then DISKUS + HANDIHALER in period 2. At the end of Visit 1, subjects will complete PQ2
Intervention: Placebo ELLIPTA (Device)
Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ2
In this sequence, subjects will be randomized to use ELLIPTA inhaler in period 1 and then DISKUS + HANDIHALER in period 2. At the end of Visit 1, subjects will complete PQ2
Intervention: Placebo DISKUS (Device)
Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ2
In this sequence, subjects will be randomized to use ELLIPTA inhaler in period 1 and then DISKUS + HANDIHALER in period 2. At the end of Visit 1, subjects will complete PQ2
Intervention: Placebo HANDIHALER (Device)
Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ2
In this sequence, subjects will be randomized to use ELLIPTA inhaler in period 1 and then DISKUS + HANDIHALER in period 2. At the end of Visit 1, subjects will complete PQ2
Intervention: PQ2 (Other)
Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ1
In this sequence, subjects will be randomized to use DISKUS + HANDIHALER in period 1 and then ELLIPTA in period 2. At the end of Visit 1, subjects will complete PQ1
Intervention: Placebo ELLIPTA (Device)
Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ1
In this sequence, subjects will be randomized to use DISKUS + HANDIHALER in period 1 and then ELLIPTA in period 2. At the end of Visit 1, subjects will complete PQ1
Intervention: Placebo DISKUS (Device)
Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ1
In this sequence, subjects will be randomized to use DISKUS + HANDIHALER in period 1 and then ELLIPTA in period 2. At the end of Visit 1, subjects will complete PQ1
Intervention: Placebo HANDIHALER (Device)
Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ3
In this sequence, subjects will be randomized to use ELLIPTA inhaler in period 1 and then TURBUHALER + HANDIHALER in period 2. At the end of Visit 1, subjects will complete version 3 of the PQ (PQ3)
Intervention: Placebo ELLIPTA (Device)
Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ3
In this sequence, subjects will be randomized to use ELLIPTA inhaler in period 1 and then TURBUHALER + HANDIHALER in period 2. At the end of Visit 1, subjects will complete version 3 of the PQ (PQ3)
Intervention: Placebo TURBUHALER (Device)
Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ3
In this sequence, subjects will be randomized to use ELLIPTA inhaler in period 1 and then TURBUHALER + HANDIHALER in period 2. At the end of Visit 1, subjects will complete version 3 of the PQ (PQ3)
Intervention: Placebo HANDIHALER (Device)
Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ3
In this sequence, subjects will be randomized to use ELLIPTA inhaler in period 1 and then TURBUHALER + HANDIHALER in period 2. At the end of Visit 1, subjects will complete version 3 of the PQ (PQ3)
Intervention: PQ3 (Other)
Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ4
In this sequence, subjects will be randomized to use TURBUHALER + HANDIHALER inhaler in period 1 and then ELLIPTA in period 2. At the end of Visit 1, subjects will complete version 4 of the PQ (PQ4)
Intervention: Placebo ELLIPTA (Device)
Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ4
In this sequence, subjects will be randomized to use TURBUHALER + HANDIHALER inhaler in period 1 and then ELLIPTA in period 2. At the end of Visit 1, subjects will complete version 4 of the PQ (PQ4)
Intervention: Placebo TURBUHALER (Device)
Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ4
In this sequence, subjects will be randomized to use TURBUHALER + HANDIHALER inhaler in period 1 and then ELLIPTA in period 2. At the end of Visit 1, subjects will complete version 4 of the PQ (PQ4)
Intervention: Placebo HANDIHALER (Device)
Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ4
In this sequence, subjects will be randomized to use TURBUHALER + HANDIHALER inhaler in period 1 and then ELLIPTA in period 2. At the end of Visit 1, subjects will complete version 4 of the PQ (PQ4)
Intervention: PQ4 (Other)
Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ4
In this sequence, subjects will be randomized to use ELLIPTA inhaler in period 1 and then TURBUHALER + HANDIHALER in period 2. At the end of Visit 1, subjects will complete PQ4
Intervention: Placebo ELLIPTA (Device)
Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ4
In this sequence, subjects will be randomized to use ELLIPTA inhaler in period 1 and then TURBUHALER + HANDIHALER in period 2. At the end of Visit 1, subjects will complete PQ4
Intervention: Placebo TURBUHALER (Device)
Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ4
In this sequence, subjects will be randomized to use ELLIPTA inhaler in period 1 and then TURBUHALER + HANDIHALER in period 2. At the end of Visit 1, subjects will complete PQ4
Intervention: Placebo HANDIHALER (Device)
Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ4
In this sequence, subjects will be randomized to use ELLIPTA inhaler in period 1 and then TURBUHALER + HANDIHALER in period 2. At the end of Visit 1, subjects will complete PQ4
Intervention: PQ4 (Other)
Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ3
In this sequence, subjects will be randomized to use TURBUHALER + HANDIHALER inhaler in period 1 and then ELLIPTA in period 2. At the end of Visit 1, subjects will complete PQ3
Intervention: Placebo ELLIPTA (Device)
Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ3
In this sequence, subjects will be randomized to use TURBUHALER + HANDIHALER inhaler in period 1 and then ELLIPTA in period 2. At the end of Visit 1, subjects will complete PQ3
Intervention: Placebo TURBUHALER (Device)
Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ3
In this sequence, subjects will be randomized to use TURBUHALER + HANDIHALER inhaler in period 1 and then ELLIPTA in period 2. At the end of Visit 1, subjects will complete PQ3
Intervention: Placebo HANDIHALER (Device)
Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ3
In this sequence, subjects will be randomized to use TURBUHALER + HANDIHALER inhaler in period 1 and then ELLIPTA in period 2. At the end of Visit 1, subjects will complete PQ3
Intervention: PQ3 (Other)
Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ1
In this sequence, subjects will be randomized to use DISKUS + HANDIHALER in period 1 and then ELLIPTA in period 2. At the end of Visit 1, subjects will complete PQ1
Intervention: PQ1 (Other)
Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ1
In this sequence, subjects will be randomized to use ELLIPTA inhaler in period 1 and then DISKUS + HANDIHALER in period 2. At the end of Visit 1, subjects will complete version 1 of the PQ (PQ1)
Intervention: PQ1 (Other)
Outcomes
Primary Outcomes
Percentage of Participants Making at Least One Critical Error After Reading the Patient Information Leaflets (PIL)
Time Frame: Day 1
Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. A critical error was defined as an error that was most likely to result in no, or a significantly reduced amount, of medication being inhaled by the participant. After reading the PIL for each DPI to be tested, participants demonstrated the DPI and critical errors made by the participants while using each DPI were recorded by the Healthcare Professional (HCP) on the checklists provided. Percentage of participants making at least one critical error after reading PIL were reported.
Secondary Outcomes
- The Median Time to Demonstrate Correct Inhaler Use (T1+T2)(Day 1)
- Time Taken to Read the PIL and Demonstrate Correct Inhaler Use (T1)(Day 1)
- Time Taken to be Given Instruction by the HCP (up to 2 Times) on Use of the Inhaler and to Demonstrate Correct Inhaler Use (T2)(Day 1)
- Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP(Day 1)
- Percentage of Participants Making at Least One Critical Error After the Second Instruction From the HCP(Day 1)
- Percentage of Participants Making at Least One Overall Error After Reading the PIL(Day 1)
- Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP(Day 1)
- Percentage of Participants Making at Least One Overall Error After the Second Instruction From the HCP(Day 1)
- Number of Participants With Instructions (0, 1 or 2 Times) From the HCP Which Are Needed to Demonstrate Correct Inhaler Use(Day 1)
- Number of Participants With Treatment Preference Based on Responses to the Preference Questionnaire, Which Considered the Number of Steps Required to Take the COPD Medication(Day 1)
- Number of Participants With Treatment Preference Based on Responses to the Preference Questionnaire, Which Considered Overall Treatment Preference(Day 1)