A Clinical Study Assessing Critical Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA® Dry Powder Inhaler, in Comparison to Combinations of Dry Powder Inhalers Used to Provide Triple Therapy, in Patients With Chronic Obstructive Pulmonary Disease
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)
1 other identifier
interventional
160
2 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2016
Shorter than P25 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2016
CompletedFirst Posted
Study publicly available on registry
December 5, 2016
CompletedStudy Start
First participant enrolled
December 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2017
CompletedResults Posted
Study results publicly available
October 21, 2019
CompletedOctober 21, 2019
September 1, 2019
6 months
December 1, 2016
June 11, 2018
September 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Making at Least One Critical Error After Reading the Patient Information Leaflets (PIL)
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.
Day 1
Secondary Outcomes (11)
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
- +6 more secondary outcomes
Study Arms (8)
Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ1
EXPERIMENTALIn 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)
Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ2
EXPERIMENTALIn 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)
Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ2
EXPERIMENTALIn 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
Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ1
EXPERIMENTALIn 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
Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ3
EXPERIMENTALIn 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)
Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ4
EXPERIMENTALIn 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)
Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ4
EXPERIMENTALIn 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
Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ3
EXPERIMENTALIn 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
Interventions
It is a dry powder inhaler device that can hold two individual blisters: one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate.
It is a placebo dry powder inhaler with one blister strip containing lactose monohydrate.
It is a placebo dry powder inhaler containing lactose monohydrate.
Placebo capsules contain lactose monohydrate in the form of powder for oral inhalation, to be used with HANDIHALER device.
Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions, but differ in the ordering of inhalers in their responses.
Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions.
Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions.
Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions.
Eligibility Criteria
You may qualify if:
- Age \>=40 years at Visit 1
- Diagnosis of COPD with a documented history of COPD, in accordance with the definition by the European Respiratory Society.
- Current COPD Therapy: Currently receiving maintenance therapy with a fixed dose combination of a long-acting beta 2-agonist (LABA) and inhaled corticosteroid (ICS). Subject may also be receiving long-acting muscarinic antagonist (LAMA; also known as a long-acting anti-cholinergic). Subjects must be able to continue using their currently prescribed COPD maintenance inhaler therapy throughout the study and as needed short acting beta-adrenergic agonist (SABA) and/or short acting muscarinic antagonist (SAMA) for rescue use.
- Has been on current maintenance ICS/LABA COPD treatment for at least 4 weeks prior to V0 and evaluated as unlikely to change treatment within 4 weeks of Visit 1.
- Current or former (defined as subjects who have quit smoking for at least 3 months prior to V0/V1) cigarette smokers with a \>10 pack-year smoking history (Number of pack years=\[number of cigarettes per day ÷ 20\] x number of years smoked \[e.g., 10 pack-years is equal to 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years\]).
- Males or females who are not pregnant or not planning a pregnancy during the study or not lactating
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
You may not qualify if:
- Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD.
- Subjects who used any ELLIPTA inhaler (participated in a clinical study of GW685698, GW642444, GSK573719 \[fluticasone furoate, vilanterol, umeclidinium bromide\], or any combination thereof, or placebo in an ELLIPTA inhaler study) within 24 months prior to Visit 0.
- Subjects who used any capsule system inhaler (e.g. Spiriva HANDIHALER, SEEBRI®/ULTIBRO® BREEZHALER®, or participated in a clinical studies of these, including placebo inhalers) within 24 months prior to Visit 0. SEEBRI, ULTIBRO, and BREEZHALER are registered trademarks of Novartis AG.
- Dependent on which sub-study a subject is included on they should not have any recent experience, within 24 months of V 0 of the following inhaler for the sub study included on: Sub Study 1: DISKUS inhaler (e.g., Seretide DISKUS or placebo DISKUS) and Sub Study 2:TURBUHALER (e.g. Symbicort TURBUHALER or placebo TURBUHALER)
- Subjects with a known or suspected alcohol or drug abuse at Visit 1 which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirement
- A history of hypersensitivity to any components of the study inhaler (e.g., lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates participation will also be excluded.
- 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 drug half-lives of the investigational drug, whichever is longer
- In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a questionnaire and understand verbal instructions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (5)
GSK Investigational Site
Enschede, 7513 ER, Netherlands
GSK Investigational Site
Nijverdal, 7442 LS, Netherlands
GSK Investigational Site
Rotterdam, 3051 GV, Netherlands
GSK Investigational Site
London, EC1M 6BQ, United Kingdom
GSK Investigational Site
London, NW10 7EW, United Kingdom
Related Publications (1)
van der Palen J, Moeskops-van Beurden W, Dawson CM, James WY, Preece A, Midwinter D, Barnes N, Sharma R. A randomized, open-label, single-visit, crossover study simulating triple-drug delivery with Ellipta compared with dual inhaler combinations in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2018 Aug 21;13:2515-2523. doi: 10.2147/COPD.S169060. eCollection 2018.
PMID: 30174421BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2016
First Posted
December 5, 2016
Study Start
December 30, 2016
Primary Completion
June 19, 2017
Study Completion
June 19, 2017
Last Updated
October 21, 2019
Results First Posted
October 21, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share