Pulmonary Disease, Chronic ObstructivePhase 4NCT02982187
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 Phase 4 study testing PQ1 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 5 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- PQ1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 30 Dec 2016to 19 Jun 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Netherlands3 sites
GSK Investigational Site
Enschede, 7513 ER
GSK Investigational Site
Nijverdal, 7442 LS
GSK Investigational Site
Rotterdam, 3051 GV
United Kingdom2 sites
GSK Investigational Site
London, EC1M 6BQ
GSK Investigational Site
London, NW10 7EW
About this study
Official title: 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)
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Placebo ELLIPTA, Placebo DISKUS, Placebo TURBUHALER, Placebo HANDIHALER, PQ1
- Keywords
- HANDIHALER, ELLIPTA, TURBUHALER, DISKUS, COPD, critical error, inhaler preference
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo ELLIPTADevice
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.
Placebo DISKUSDevice
It is a placebo dry powder inhaler with one blister strip containing lactose monohydrate.
Placebo TURBUHALERDevice
It is a placebo dry powder inhaler containing lactose monohydrate.
Placebo HANDIHALERDevice
Placebo capsules contain lactose monohydrate in the form of powder for oral inhalation, to be used with HANDIHALER device.
PQ1Other
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.
PQ2Other
Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions.
PQ3Other
Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions.
PQ4Other
Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions.
| Study group | Role | What they receive |
|---|---|---|
| Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ1 | Experimental | 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) Receives: Device: Placebo ELLIPTA; Device: Placebo DISKUS; Device: Placebo HANDIHALER; Other: PQ1 |
| Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ2 | Experimental | 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) Receives: Device: Placebo ELLIPTA; Device: Placebo DISKUS; Device: Placebo HANDIHALER; Other: PQ2 |
| Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ2 | Experimental | 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 Receives: Device: Placebo ELLIPTA; Device: Placebo DISKUS; Device: Placebo HANDIHALER; Other: PQ2 |
| Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ1 | Experimental | 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 Receives: Device: Placebo ELLIPTA; Device: Placebo DISKUS; Device: Placebo HANDIHALER; Other: PQ1 |
| Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ3 | Experimental | 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) Receives: Device: Placebo ELLIPTA; Device: Placebo TURBUHALER; Device: Placebo HANDIHALER; Other: PQ3 |
| Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ4 | Experimental | 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) Receives: Device: Placebo ELLIPTA; Device: Placebo TURBUHALER; Device: Placebo HANDIHALER; Other: PQ4 |
| Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ4 | Experimental | 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 Receives: Device: Placebo ELLIPTA; Device: Placebo TURBUHALER; Device: Placebo HANDIHALER; Other: PQ4 |
| Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ3 | Experimental | 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 Receives: Device: Placebo ELLIPTA; Device: Placebo TURBUHALER; Device: Placebo HANDIHALER; Other: PQ3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (11)
Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP
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 PIL for each DPI to be tested, participants demonstrated the DPI and errors made by the participants while using each DPI were recorded by the HCP on the checklists provided. If a participant made errors while demonstrating DPI, HCP provided instruction on the correct use of the DPI. The participant then repeated the demonstration of DPI use, and the HCP recorded the critical errors made on the checklists. Percentage of participants making at least one critical error after the first instruction from the HCP were reported.
Measured: Day 1
Percentage of Participants Making at Least One Critical Error After the Second Instruction From the HCP
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 errors made by the participants while using each DPI were recorded by the HCP on the checklists provided. If a participant made an error while demonstrating DPI use after first instruction from the HCP, then the HCP provided instructions again on the correct use of the inhaler. The participant then demonstrated the DPI for one last time, and the HCP recorded the critical errors made on the checklists. Participants making at least one critical error after the second instruction from the HCP were reported.
Measured: Day 1
Percentage of Participants Making at Least One Overall Error After Reading the PIL
Participants were provided with the relevant section of the PIL, explaining correct use, for each DPI they were to be tested on. Overall error was defined as an error including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL. For each DPI to be tested, overall errors including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL were recorded by the HCP on the checklists provided. Percentage of participants making at least one overall error after reading the PIL were reported.
Measured: Day 1
Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP
For each DPI to be tested, overall errors including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL following first instruction from the HCP were recorded by the HCP on the checklists provided. Percentage of participants making at least one overall error after the first instruction from the HCP were reported.
Measured: Day 1
Percentage of Participants Making at Least One Overall Error After the Second Instruction From the HCP
For each DPI to be tested, overall errors including critical and non-critical errors made by the participants while demonstrating DPI use after reading the PIL following first, and second instruction from the HCP were recorded by the HCP on the checklists provided. Percentage of participants making at least one overall error after the second instruction from the HCP were reported. These statistics are only presented when the model has successfully converged.
Measured: Day 1
Number of Participants With Instructions (0, 1 or 2 Times) From the HCP Which Are Needed to Demonstrate Correct Inhaler Use
In each sub-study, if the participant made error while demonstrating the use of the DPI after reading the PIL, the HCP demonstrated the correct usage instructions to the participant. The participant was then asked to demonstrate the DPI again. Any errors made were recorded by the HCP, and the same process was repeated one more time. In total, the HCP instructed the participants on the use of the DPI up to two times after which there were no assessment scheduled. Number of participants with instructions (0, 1 or 2) needed to demonstrate correct DPI use by the participants were reported.
Measured: Day 1
The Median Time to Demonstrate Correct Inhaler Use (T1+T2)
For each DPI being tested, the total time taken from when participant started reading the PIL until when correct use was demonstrated (that is the time required to read PIL, and two attempts for correct use of DPI following instructions provided by the HCP ) was recorded. A participant who did not demonstrate correct use at the end of the time period was censored. The median time to demonstrate correct DPI use (minutes) is taken from the Kaplan-Meier analysis. If more than 50% of the data is censored therefore the median is not applicable.
Measured: Day 1
Time Taken to Read the PIL and Demonstrate Correct Inhaler Use (T1)
For each DPI being tested, the time taken from when participant started reading the PIL until when correct use was demonstrated with no need of instructions by HCP was reported. A participant who did not demonstrate correct use at the end of the time period was censored. The median time to demonstrate correct DPI use (minutes) is taken from the Kaplan-Meier analysis. If more than 50% of the data is censored therefore the median is not applicable.
Measured: 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)
The time in minutes from when the HCP started to instruct participant for the correct use of DPI until correct use was demonstrated including maximum of two attempts only, was recorded. A participant who did not demonstrate correct use at the end of the time period was censored. Participants who demonstrated correct use after reading the PIL (T1) were included with a time of 0 for T2. The median time to demonstrate correct DPI use (minutes) is taken from the Kaplan-Meier analysis. If more than 50% of the data is censored then the median is not applicable. Participants who demonstrated correct use after reading the PIL are included with T2=0.
Measured: 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
Participants demonstrated the use of ELLIPTA, and depending on the substudy DISKUS plus HandiHaler or Turbuhaler plus Handihaler. At the end of Visit 1, participants completed specific versions of the inhaler PQ (PQ1, PQ2, PQ3 or PQ4) according to the questionnaire they were randomized to. Participants assessed the inhaler preference based on the number of steps needed to take the COPD medication. Participants checked the response from the choice of ELLIPTA, DISKUS + HandiHaler (sub-study 1), Turbuhaler + Handihaler (sub-study 2) and No Preference. Number of participants with treatment preference based on responses to the preference questionnaire were reported.
Measured: Day 1
Number of Participants With Treatment Preference Based on Responses to the Preference Questionnaire, Which Considered Overall Treatment Preference
Participants demonstrated the use of ELLIPTA, and depending on the substudy DISKUS plus HandiHaler or Turbuhaler plus Handihaler. At the end of Visit 1, participants completed specific versions of the inhaler PQ (PQ1, PQ2, PQ3 or PQ4) according to the questionnaire they were randomized to. Participants assessed the inhaler preference based on overall treatment preference. Participants checked the response from the choice of ELLIPTA, DISKUS + HandiHaler (sub-study 1), Turbuhaler + Handihaler (sub-study 2) and No Preference. Number of participants with treatment preference based on responses to the preference questionnaire were reported.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start30 Dec 2016
- Primary completion19 Jun 2017
- Study completion19 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982187
- Sponsor's protocol ID
- 206215
- Status last verified
- Sep 2019
- First submitted
- 1 Dec 2016
- Last updated
- 21 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30174421
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02982187
- Acronym / sponsor ID
- 206215
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- HANDIHALER, ELLIPTA, TURBUHALER, DISKUS, COPD, critical error, inhaler preference
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2016 (actual)
- Primary completion
- 19 Jun 2017 (actual)
- Study completion
- 19 Jun 2017 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Posted 21 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ1 | Experimental | Device: Placebo ELLIPTA, Device: Placebo DISKUS, Device: Placebo HANDIHALER, Other: PQ1In 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 | Experimental | Device: Placebo ELLIPTA, Device: Placebo DISKUS, Device: Placebo HANDIHALER, Other: PQ2In 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 | Experimental | Device: Placebo ELLIPTA, Device: Placebo DISKUS, Device: Placebo HANDIHALER, Other: PQ2In 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 | Experimental | Device: Placebo ELLIPTA, Device: Placebo DISKUS, Device: Placebo HANDIHALER, Other: PQ1In 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 | Experimental | Device: Placebo ELLIPTA, Device: Placebo TURBUHALER, Device: Placebo HANDIHALER, Other: PQ3In 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 | Experimental | Device: Placebo ELLIPTA, Device: Placebo TURBUHALER, Device: Placebo HANDIHALER, Other: PQ4In 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 | Experimental | Device: Placebo ELLIPTA, Device: Placebo TURBUHALER, Device: Placebo HANDIHALER, Other: PQ4In 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 | Experimental | Device: Placebo ELLIPTA, Device: Placebo TURBUHALER, Device: Placebo HANDIHALER, Other: PQ3In 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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]).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo ELLIPTAIt 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. | Device | Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ1, Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ2, Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ1, Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ2, Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ3, Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ4, Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ3, Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ4 |
| Placebo DISKUSIt is a placebo dry powder inhaler with one blister strip containing lactose monohydrate. | Device | Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ1, Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ2, Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ1, Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ2 |
| Placebo TURBUHALERIt is a placebo dry powder inhaler containing lactose monohydrate. | Device | Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ3, Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ4, Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ3, Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ4 |
| Placebo HANDIHALERPlacebo capsules contain lactose monohydrate in the form of powder for oral inhalation, to be used with HANDIHALER device. | Device | Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ1, Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ2, Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ1, Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ2, Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ3, Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ4, Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ3, Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ4 |
| PQ1Consists 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. | Other | Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ1, Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ1 |
| PQ2Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions. | Other | Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ2, Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ2 |
| PQ3Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions. | Other | Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ3, Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ3 |
| PQ4Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions. | Other | Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ4, Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ4 |
Primary outcome
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.
11 secondary outcomes
Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP
Time frame: Day 1
Percentage of Participants Making at Least One Critical Error After the Second Instruction From the HCP
Time frame: Day 1
Percentage of Participants Making at Least One Overall Error After Reading the PIL
Time frame: Day 1
Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP
Time frame: Day 1
Percentage of Participants Making at Least One Overall Error After the Second Instruction From the HCP
Time frame: Day 1
Number of Participants With Instructions (0, 1 or 2 Times) From the HCP Which Are Needed to Demonstrate Correct Inhaler Use
Time frame: Day 1
The Median Time to Demonstrate Correct Inhaler Use (T1+T2)
Time frame: Day 1
Time Taken to Read the PIL and Demonstrate Correct Inhaler Use (T1)
Time frame: 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)
Time frame: 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
Time frame: Day 1
Number of Participants With Treatment Preference Based on Responses to the Preference Questionnaire, Which Considered Overall Treatment Preference
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30174421van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PQ1 in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Making at Least One Critical Error After Reading the Patient Information Leaflets (PIL) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02982187, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2019.