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
NCT ID: NCT02982187
Last Updated: 2019-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
160 participants
INTERVENTIONAL
2016-12-30
2017-06-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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)
Placebo ELLIPTA
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 DISKUS
It is a placebo dry powder inhaler with one blister strip containing lactose monohydrate.
Placebo HANDIHALER
Placebo capsules contain lactose monohydrate in the form of powder for oral inhalation, to be used with HANDIHALER device.
PQ1
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.
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)
Placebo ELLIPTA
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 DISKUS
It is a placebo dry powder inhaler with one blister strip containing lactose monohydrate.
Placebo HANDIHALER
Placebo capsules contain lactose monohydrate in the form of powder for oral inhalation, to be used with HANDIHALER device.
PQ2
Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions.
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
Placebo ELLIPTA
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 DISKUS
It is a placebo dry powder inhaler with one blister strip containing lactose monohydrate.
Placebo HANDIHALER
Placebo capsules contain lactose monohydrate in the form of powder for oral inhalation, to be used with HANDIHALER device.
PQ2
Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions.
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
Placebo ELLIPTA
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 DISKUS
It is a placebo dry powder inhaler with one blister strip containing lactose monohydrate.
Placebo HANDIHALER
Placebo capsules contain lactose monohydrate in the form of powder for oral inhalation, to be used with HANDIHALER device.
PQ1
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.
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)
Placebo ELLIPTA
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 TURBUHALER
It is a placebo dry powder inhaler containing lactose monohydrate.
Placebo HANDIHALER
Placebo capsules contain lactose monohydrate in the form of powder for oral inhalation, to be used with HANDIHALER device.
PQ3
Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions.
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)
Placebo ELLIPTA
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 TURBUHALER
It is a placebo dry powder inhaler containing lactose monohydrate.
Placebo HANDIHALER
Placebo capsules contain lactose monohydrate in the form of powder for oral inhalation, to be used with HANDIHALER device.
PQ4
Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions.
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
Placebo ELLIPTA
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 TURBUHALER
It is a placebo dry powder inhaler containing lactose monohydrate.
Placebo HANDIHALER
Placebo capsules contain lactose monohydrate in the form of powder for oral inhalation, to be used with HANDIHALER device.
PQ4
Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions.
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
Placebo ELLIPTA
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 TURBUHALER
It is a placebo dry powder inhaler containing lactose monohydrate.
Placebo HANDIHALER
Placebo capsules contain lactose monohydrate in the form of powder for oral inhalation, to be used with HANDIHALER device.
PQ3
Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions.
Interventions
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Placebo ELLIPTA
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 DISKUS
It is a placebo dry powder inhaler with one blister strip containing lactose monohydrate.
Placebo TURBUHALER
It is a placebo dry powder inhaler containing lactose monohydrate.
Placebo HANDIHALER
Placebo capsules contain lactose monohydrate in the form of powder for oral inhalation, to be used with HANDIHALER device.
PQ1
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.
PQ2
Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions.
PQ3
Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions.
PQ4
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
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
40 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Enschede, , Netherlands
GSK Investigational Site
Nijverdal, , Netherlands
GSK Investigational Site
Rotterdam, , Netherlands
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
London, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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206215
Identifier Type: -
Identifier Source: org_study_id
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