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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Other: PQ4; Other: PQ1; Device: Placebo DISKUS; Other: PQ2; Other: PQ3; Device: Placebo TURBUHALER; Device: Placebo HANDIHALER; Device: Placebo ELLIPTA

Study type: Interventional

Funder types: Industry

Identifiers

NCT02982187

206215

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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160 participants in 8 patient groups

Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ1

Experimental group

Description:

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)

Treatment:

Device: Placebo DISKUS

Device: Placebo HANDIHALER

Device: Placebo ELLIPTA

Other: PQ1

Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ2

Experimental group

Description:

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)

Treatment:

Device: Placebo DISKUS

Device: Placebo HANDIHALER

Device: Placebo ELLIPTA

Other: PQ2

Sub-study 1 : ELLIPTA followed by DISKUS+ HANDIHALER +PQ2

Experimental group

Description:

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

Treatment:

Device: Placebo DISKUS

Device: Placebo HANDIHALER

Device: Placebo ELLIPTA

Other: PQ2

Sub-study 1 : DISKUS + HANDIHALER followed by ELLIPTA+PQ1

Experimental group

Description:

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

Treatment:

Device: Placebo DISKUS

Device: Placebo HANDIHALER

Device: Placebo ELLIPTA

Other: PQ1

Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ3

Experimental group

Description:

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)

Treatment:

Other: PQ3

Device: Placebo HANDIHALER

Device: Placebo TURBUHALER

Device: Placebo ELLIPTA

Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ4

Experimental group

Description:

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)

Treatment:

Device: Placebo HANDIHALER

Device: Placebo TURBUHALER

Other: PQ4

Device: Placebo ELLIPTA

Substudy 2: ELLIPTA followed by TURBUHALER + HANDIHALER +PQ4

Experimental group

Description:

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

Treatment:

Device: Placebo HANDIHALER

Device: Placebo TURBUHALER

Other: PQ4

Device: Placebo ELLIPTA

Substudy 2: TURBUHALER + HANDIHALER followed by ELLIPTA+PQ3

Experimental group

Description:

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

Treatment:

Other: PQ3

Device: Placebo HANDIHALER

Device: Placebo TURBUHALER

Device: Placebo ELLIPTA