Pulmonary Disease, Chronic ObstructivePhase 4NCT02184624

Study of Inhaler Device Attributes Investigating Critical and Overall Errors, Ease of Use, and Preference Between a Number of Inhaler Devices

A Phase 4 study testing ELLIPTA, DISKUS/ACCUHALER and MDI in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: ELLIPTA, DISKUS/ACCUHALER and MDI
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 569 participants
Where: 8 sitesin 2 countries
Study dates: 28 Aug 2014to 31 Jul 2015
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

Informed consent: Subject must give their signed and dated written informed consent to participate in the study; Subject understands and is willing, able, and likely to comply with study procedures and restrictions; Subject must be able to read, comprehend, and record information in Dutch and/or English.
Age: >=40 years of age
Gender: Male or female subjects.
Primary diagnosis of COPD: subjects with a clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society. Comorbidities (rheumatoid arthritis or other locomotor problems, visual impairment, and depression or anxiety) will be documented as relevant to inhaler use.
COPD treatment: All patients should be currently receiving treatment for COPD.
Must be naïve to using ELLIPTA inhaler and at least one other inhaler device. Subjects who are naïve to the BREEZEHALER and HANDIHALER inhalers must be naïve to all other inhaler devices that requires a capsule.

Who cannot join

Asthma: Subjects with a current diagnosis of asthma only. Note: Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD.
Contraindications: A history of allergy or hypersensitivity to lactose/milk protein or magnesium stearate or to any other excipient.
Subjects who are currently participating in another randomised pharmacological interventional trial.
Inability to Read: 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

8 sites in 2 countries.

Country

City, postcode or hospital

8 sites in 2 countries

Netherlands6 sites

GSK Investigational Site
Almere Stad, 1311 RL
GSK Investigational Site
Beek, 6191 JW
GSK Investigational Site
Enschede, 7513 ER
GSK Investigational Site
Kloosterhaar, 7694 AC
GSK Investigational Site
Nijverdal, 7442 LS
GSK Investigational Site
Zutphen, 7207 AE

Other trials in Netherlands

United Kingdom2 sites

GSK Investigational Site
Portsmouth, PO6 3LY
GSK Investigational Site
Southampton, SO16 6YD

Other trials in United Kingdom

About this study

Official title: An Open-label Study of Inhaler Device Attributes Investigating Critical and Overall Errors, Ease of Use, and Preference Between a Number of Inhaler Devices (ELLIPTA, TURBUHALER, HANDIHALER, BREEZHALER, MDI, and DISKUS/ACCUHALER) in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This is a randomised, open-label, placebo, crossover, multicentre study with a single visit. The study will comprise five sub-studies. Subjects will receive inactive treatment (placebo) via the ELLIPTA® inhaler and one of the other inhaler devices depending on the sub-study they are randomised to. Only subjects who are naïve to the ELLIPTA inhaler and to one of the other inhaler devices that will be used in this study will be included. Furthermore, subjects who are naïve to the BREEZEHALER® and HANDIHALER® inhalers must be naïve to all other inhaler devices that requires a capsule. The study will be conducted in the UK and the Netherlands, and comprises one visit only. A sufficient number of subjects (at least 600) with COPD will be screened and 570 will be randomised to one of five sub-studies. Eligible subjects will be allocated to one of the sub-studies depending on their experience of using the other inhaler (i.e., depending on which other inhaler they are naïve to).

This study is designed to assess the proportion of COPD subjects making critical and overall (i.e., critical and non-critical errors) errors in using ELLIPTA inhaler and other commercially available inhaler devices such as the TURBUHALER®, HANDIHALER, BREEZHALER, MDI and DISKUS®/ACCUHALER® inhalers. This study will also assess the 'ease of use' and preference between the ELLIPTA inhaler and the other commercially available inhaler devices.

ELLIPTA, DISKUS, and ACCUHALER are registered trademarks of the GSK group of companies. TURBUHALER is a registered trademark of AstraZeneca. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH \& Co. KG. BREEZHALER is a registered trademark of Novartis AG.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: ELLIPTA, DISKUS/ACCUHALER, MDI, TURBUHALER, HANDIHALER
Keywords: BREEZHALER, DISKUS/ACCUHALER, MDI, Inhaler preference, Overall inhaler error, HANDIHALER, Ease of use, TURBUHALER, ELLIPTA, Critical inhaler error
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.

ELLIPTADevice
Dry powder inhaler (placebo) with two blister strips. One placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate.
DISKUS/ACCUHALERDevice
Placebo inhaler with one blister strip containing lactose monohydrate.
MDIDevice
Placebo inhaler containing propellant (1,1,1, 2-Tetrafluoroethane).
TURBUHALERDevice
Placebo inhaler containing lactose monohydrate.
HANDIHALERDevice
Placebo inhaler containing lactose monohydrate in a capsule.
BREEZEHALERDevice
Placebo inhaler containing lactose monohydrate in a capsule.

Study groups in NCT02184624
Study group	Role	What they receive
Sub-Study 1	Experimental	Subjects will be randomized to either use ELLIPTA inhaler first and then DISKUS/ACCUHALER inhaler or use DISKUS/ACCUHALER inhaler first and then ELLIPTA inhaler. Receives: Device: ELLIPTA; Device: DISKUS/ACCUHALER
Sub-Study 2	Experimental	Subjects will be randomized to either use ELLIPTA inhaler first and then MDI inhaler or use MDI inhaler first and then ELLIPTA inhaler. Receives: Device: ELLIPTA; Device: MDI
Sub-Study 3	Experimental	Subjects will be randomized to either use ELLIPTA inhaler first and then TURBUHALER inhaler or use TURBUHALER inhaler first and then ELLIPTA. Receives: Device: ELLIPTA; Device: TURBUHALER
Sub-Study 4	Experimental	Subjects will be randomized to either use ELLIPTA inhaler first and then HANDIHALER inhaler or use HANDIHALER inhaler first and then ELLIPTA inhaler. Receives: Device: ELLIPTA; Device: HANDIHALER
Sub-Study 5	Experimental	Subjects will be randomized to either use ELLIPTA inhaler first and then BREEZEHALER inhaler or use BREEZEHALER inhaler first and then ELLIPTA inhaler. Receives: Device: ELLIPTA; Device: BREEZEHALER

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet
A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. The percentage of participants who made at least one critical error was reported for each inhaler regardless sequence.
Measured: Day 1

Secondary outcomes (6)

Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet
An overall error includes a critical and non-critical error. Any error made by the participants while demonstrating the use of the inhaler after reading the patient instruction leaflet was recorded by health care professional (HCP). The percentage of participants who made at least one overall error was reported. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1.
Measured: Day 1
Percentage of Participants Making at Least One Critical Error After the First Instruction From the HCP
A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further critical error were made by the participant, the error were recorded by HCP.
Measured: Day 1
Percentage of Participants Making at Least One Overall Error After the First Instruction From the HCP
An overall error includes a critical and non-critical error. If the participant made any error while demonstrating the use of the inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participants were then asked to demonstrate inhaler use again. If any further error was made by the participant was recorded by HCP.
Measured: Day 1
Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique
If the participant made any error while demonstrating the use of the first inhaler after reading the patient instruction leaflet, the HCP demonstrated the correct usage of the inhaler to the participant. The participant was then asked to demonstrate inhaler use again. Any errors made by the participant were recorded by the HCP. The same procedure was repeated if the participant continues to make errors in the use of the inhaler. In total, the HCP demonstrated the use of the inhaler up to three times. Same procedure was followed for second inhaler. The number of participants who demonstrated the adequate inhalation technique after third time instructions from HCP was reported.
Measured: Day 1
Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire
After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from preference questionnaire. Preference questionnaire consisted of eight questions related to both inhalers used during the study. Each question had one response to choose from 3 preference options (Other inhaler device, ELLIPTA inhaler device and No preference). The number of participants who overall preferred the ELLIPTA device compared to non-ELLIPTA inhalers (First question in the preference questionnaire) were reported.
Measured: Day 1
Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire
After completing the demonstration procedures of the inhalers, the HCP asked the participant a number of questions from ease of use questionnaire. Ease of use questionnaire consisted of six questions each for ELLIPTA inhaler and the other inhaler under study. Each question had one response to choose from 5 options of ease of use (Very easy, easy, neutral, difficult and very difficult). Based upon the response given by the participants the number of participants who rated ease of use higher for ELLIPTA, higher for non- ELLIPTA, or rated the same 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.

28 Aug 201431 Jul 2015

First posted9 Jul 2014 (estimated)
Study start28 Aug 2014
Primary completion31 Jul 2015
Study completion31 Jul 2015

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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 569 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02184624
Sponsor's protocol ID: 200301
Status last verified: Apr 2017
First submitted: 3 Jul 2014
Last updated: 23 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

van der Palen J, Thomas M, Chrystyn H, Sharma RK, van der Valk PD, Goosens M, Wilkinson T, Stonham C, Chauhan AJ, Imber V, Zhu CQ, Svedsater H, Barnes NC. A randomised open-label cross-over study of inhaler errors, preference and time to achieve correct inhaler use in patients with COPD or asthma: comparison of ELLIPTA with other inhaler devices. NPJ Prim Care Respir Med. 2016 Nov 24;26:16079. doi: 10.1038/npjpcrm.2016.79.
PubMed 27883002

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders

All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Study of Inhaler Device Attributes Investigating Critical and Overall Errors, Ease of Use, and Preference Between a Number of Inhaler Devices (ELLIPTA, TURBUHALER, HANDIHALER, BREEZHALER, MDI, and DISKUS/ACCUHALER) in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT02184624
Acronym / sponsor ID: 200301
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: BREEZHALER, DISKUS/ACCUHALER, MDI, Inhaler preference, Overall inhaler error, HANDIHALER, Ease of use, TURBUHALER
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 569 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 28 Aug 2014 (actual)
Primary completion: 31 Jul 2015 (actual)
Study completion: 31 Jul 2015 (actual)
First posted: 9 Jul 2014 (estimated)
Results: Posted 20 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Sub-Study 1	Experimental	Device: ELLIPTA, Device: DISKUS/ACCUHALERSubjects will be randomized to either use ELLIPTA inhaler first and then DISKUS/ACCUHALER inhaler or use DISKUS/ACCUHALER inhaler first and then ELLIPTA inhaler.
Sub-Study 2	Experimental	Device: ELLIPTA, Device: MDISubjects will be randomized to either use ELLIPTA inhaler first and then MDI inhaler or use MDI inhaler first and then ELLIPTA inhaler.
Sub-Study 3	Experimental	Device: ELLIPTA, Device: TURBUHALERSubjects will be randomized to either use ELLIPTA inhaler first and then TURBUHALER inhaler or use TURBUHALER inhaler first and then ELLIPTA.
Sub-Study 4	Experimental	Device: ELLIPTA, Device: HANDIHALERSubjects will be randomized to either use ELLIPTA inhaler first and then HANDIHALER inhaler or use HANDIHALER inhaler first and then ELLIPTA inhaler.
Sub-Study 5	Experimental	Device: ELLIPTA, Device: BREEZEHALERSubjects will be randomized to either use ELLIPTA inhaler first and then BREEZEHALER inhaler or use BREEZEHALER inhaler first and then ELLIPTA inhaler.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Informed consent: Subject must give their signed and dated written informed consent to participate in the study; Subject understands and is willing, able, and likely to comply with study procedures and restrictions; Subject must be able to read, comprehend, and record information in Dutch and/or English.
Age: >=40 years of age
Gender: Male or female subjects.
Primary diagnosis of COPD: subjects with a clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society. Comorbidities (rheumatoid arthritis or other locomotor problems, visual impairment, and depression or anxiety) will be documented as relevant to inhaler use.
COPD treatment: All patients should be currently receiving treatment for COPD.

Key exclusion criteria (4 listed)

Asthma: Subjects with a current diagnosis of asthma only. Note: Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD.
Contraindications: A history of allergy or hypersensitivity to lactose/milk protein or magnesium stearate or to any other excipient.
Subjects who are currently participating in another randomised pharmacological interventional trial.
Inability to Read: 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.

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
ELLIPTADry powder inhaler (placebo) with two blister strips. One placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate.	Device	Sub-Study 1, Sub-Study 2, Sub-Study 3, Sub-Study 4, Sub-Study 5
DISKUS/ACCUHALERPlacebo inhaler with one blister strip containing lactose monohydrate.	Device	Sub-Study 1
MDIPlacebo inhaler containing propellant (1,1,1, 2-Tetrafluoroethane).	Device	Sub-Study 2
TURBUHALERPlacebo inhaler containing lactose monohydrate.	Device	Sub-Study 3
HANDIHALERPlacebo inhaler containing lactose monohydrate in a capsule.	Device	Sub-Study 4
BREEZEHALERPlacebo inhaler containing lactose monohydrate in a capsule.	Device	Sub-Study 5

Primary outcome

Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet
Time frame: Day 1
A critical error was defined as an error that was most likely to result in no or only minimal medication being inhaled. The errors considered as critical errors while handling the inhaler devices were failed to open cover, lever was not pushed back, shook the device after dose preparation, exhaled directly into mouthpiece, no seal by the lips round the mouthpiece during the inhalation. As per the crossover study design participants received placebo via the ELLIPTA inhaler first and then non-ELLIPTA inhaler or non-ELLIPTA inhaler first and then ELLIPTA on Day 1. The percentage of participants who made at least one critical error was reported for each inhaler regardless sequence.

6 secondary outcomes

Percentage of Participants Who Made at Least One Overall Error After Reading the Patient Information Leaflet
Time frame: Day 1
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 Overall Error After the First Instruction From the HCP
Time frame: Day 1
Number of Participants Needed Instructions From HCP (Maximum Three Times) to Demonstrate Adequate Inhalation Technique
Time frame: Day 1
Percentage of Participants Who Overall Preferred the ELLIPTA Device Compared to Non-ELLIPTA Inhalers as Assessed by the Preference Questionnaire
Time frame: Day 1
Percentage of Participants Who Overall Found the ELLIPTA Device Easy to Use Compared With Non-ELLIPTA Inhalers as Assessed by the Ease of Use Questionnaire
Time frame: Day 1

Results and safety

Results posted to the registry on 20 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sub-study 1:ELLIPTA Versus (Vs) DISKUS/ACCUHALER	171	171
Sub-study 2: ELLIPTA Vs Metered-dose Inhaler (MDI)	80	80
Sub-study 3: ELLIPTA Vs TURBUHALER	100	100
Sub-study 4: ELLIPTA Vs HANDIHALER	118	118
Sub-study 5: ELLIPTA Vs BREEZHALER	98	98

Primary outcome: Percentage of Participants Who Made at Least One Critical Error After Reading the Patient Information Leaflet

Time frame: Day 1. Number. Unit: Percentage of participants

Measure	Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER n = 171	Sub-study 2: ELLIPTA Vs MDI n = 80	Sub-study 3: ELLIPTA Vs TURBUHALER n = 100	Sub-study 4: ELLIPTA Vs HANDIHALER n = 118	Sub-study 5: ELLIPTA Vs BREEZHALER n = 98
Error with only ELLIPTA inhaler	2	4	1	4	8
Error with only non-ELLIPTA inhaler	40	51	37	38	41
Error with both inhalers	4	9	7	10	5

Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER: p <0.001, Cochran-Mantel-Haenszel
Sub-study 2: ELLIPTA Vs MDI: p <0.001, Cochran-Mantel-Haenszel
Sub-study 3: ELLIPTA Vs TURBUHALER: p <0.001, Cochran-Mantel-Haenszel

Population analysed: Modified Intent-to-Treat Population comprised of all participants in the Intent-to-Treat Population who completed demonstration of using both study inhaler devices after reading patient information leaflet.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events and serious adverse events were collected from the start of study treatment (Day 1) and until the follow up contact.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER	0 of 171 (0%)	0 of 171 (0%)	Not reported
Sub-study 2: ELLIPTA Vs MDI	0 of 80 (0%)	0 of 80 (0%)	Not reported
Sub-study 3: ELLIPTA Vs TURBUHALER	0 of 100 (0%)	0 of 100 (0%)	Not reported
Sub-study 4: ELLIPTA Vs HANDIHALER	0 of 118 (0%)	0 of 118 (0%)	Not reported
Sub-study 5: ELLIPTA Vs BREEZHALER	0 of 98 (0%)	0 of 98 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27883002van der Palen J, Thomas M, Chrystyn H, Sharma RK, van der Valk PD, Goosens M, Wilkinson T, Stonham C, Chauhan AJ, Imber V, Zhu CQ, Svedsater H, Barnes NC. A randomised open-label cross-over study of inhaler errors, preference and time to achieve correct inhaler use in patients with COPD or asthma: comparison of ELLIPTA with other inhaler devices. NPJ Prim Care Respir Med. 2016 Nov 24;26:16079. doi: 10.1038/npjpcrm.2016.79.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Related trials for Pulmonary Disease, Chronic Obstructive

Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders

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

8 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 ELLIPTA, DISKUS/ACCUHALER and MDI in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 8 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 6 inclusion and 4 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 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 20 Mar 2017). 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 Who Made at Least One Critical Error After Reading the Patient Information Leaflet (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 NCT02184624, 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 23 May 2017.