Preference Attributes of ELLIPTA Dry Powder Inhaler (DPI) and HANDIHALER DPI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
An Open-label Study to Evaluate the Preference Attributes of the ELLIPTA™ Dry Powder Inhaler (DPI) Compared to the HandiHaler™ DPI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
214
1 country
22
Brief Summary
This is a Phase IV multi-center, randomized, open-label, cross-over, placebo study in subjects with Chronic Obstructive Pulmonary Disease (COPD) to compare inhaler-specific preference attributes of two inhalers - ELLIPTA dry powder inhaler (DPI) and the HANDIHALER DPI. The primary objective of this study is to evaluate whether more subjects with COPD prefer the ELLIPTA inhaler to the HANDIHALER DPI based on the number of steps needed to take medication. All subjects will use the ELLIPTA inhaler and the HANDIHALER inhaler in the corresponding treatment periods based on the randomisation scheme, and at the end of 2 periods, complete the inhaler preference questionnaire. Subjects will self-administer the inhalation once daily for 5-9 days in each treatment period. This study will be placebo-only, and neither inhaler will contain active treatment. Subjects will continue their current COPD medication(s) as prescribed, and will follow up with their regular physician for their COPD healthcare during the study. Approximately 211 subjects will be enrolled in the study. ELLIPTA is a trademark of the GlaxoSmithKline group of companies. HANDIHALER is a trademark of Boehringer Ingelheim International GmbH.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2016
Shorter than P25 for phase_4
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2016
CompletedFirst Posted
Study publicly available on registry
June 1, 2016
CompletedStudy Start
First participant enrolled
June 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2016
CompletedResults Posted
Study results publicly available
June 22, 2017
CompletedOctober 15, 2018
September 1, 2018
4 months
May 26, 2016
May 30, 2017
September 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Preferring the Inhaler Based on the Number of Steps Needed to Take the COPD Medication
Preference between ELLIPTA inhaler and Handihaler based on the number of steps needed to take the medication was assessed by the inhaler preference questionnaire at Visit 3 or Early Withdrawal (EW) visit. The responses were analyzed using a Cochran-Mantel-Haenszel test, adjusted for study inhaler use sequence and preference questionnaire version. The analysis was performed on the Modified Intent-to-treat (ITT) Population comprised of all participants in the ITT Population (comprised all randomized participants who received 1 dose of at least 1 study inhaler) who completed at least one question from the 5 preference questions.
Up to 18 days
Secondary Outcomes (2)
Percentage of Participants Preferring the Inhaler Based on How Easy it Was to Tell How Many Doses Were Left
Up to 18 days
Percentage of Participants Preferring the Inhaler Based on the Size of the Inhaler
Up to 18 days
Study Arms (4)
ELLIPTA - HANDIHALER; HANDIHALER Questionnaire Version 1
EXPERIMENTALSubjects will be dispensed the ELLIPTA inhaler at Visit 1 to use during the first period (once daily for 5-9 days), and the HANDIHALER inhaler at Visit 2 to use during the second period (once daily for 5-9 days). At Visit 3, subjects will complete Version 1 of the inhaler preference questionnaire.
ELLIPTA - HANDIHALER; Questionnaire Version 2
EXPERIMENTALSubjects will be dispensed the ELLIPTA inhaler at Visit 1 to use during the first period (once daily for 5-9 days), and the HANDIHALER inhaler at Visit 2 to use during the second period (once daily for 5-9 days). At Visit 3, subjects will complete Version 2 of the inhaler preference questionnaire.
HANDIHALER - ELLIPTA; Questionnaire Version 1
EXPERIMENTALSubjects will be dispensed the HANDIHALER inhaler at Visit 1 to use during the first period (once daily for 5-9 days), and the ELLIPTA inhaler at Visit 2 to use during the second period (once daily for 5-9 days). At Visit 3, subjects will complete Version 1 of the inhaler preference questionnaire.
HANDIHALER - ELLIPTA; Questionnaire Version 2
EXPERIMENTALSubjects will be dispensed the HANDIHALER inhaler at Visit 1 to use during the first period (once daily for 5-9 days), and the ELLIPTA inhaler at Visit 2 to use during the second period (once daily for 5-9 days). At Visit 3, subjects will complete Version 2 of the inhaler preference questionnaire.
Interventions
Placebo ELLIPTA is a DPI device containing powder for inhalation, to be inhaled orally once daily for 5-9 days. It contains two strips with 30 blisters per strip - one strip contains lactose monohydrate whereas the other strip contains lactose monohydrate blended with magnesium stearate.
Placebo capsules contain lactose monohydrate in the form of powder for inhalation, to be used with the HANDIHALER inhaler as an oral inhalation once daily for 5-9 days.
Consists of 5 questions to assess subjects' preference of device attributes and dosing regimens. The two versions of the questionnaire ask the same questions, but differ in the ordering of inhalers in their responses.
Consists of 5 questions to assess subjects' preference of device attributes and dosing regimens. The two versions of the questionnaire ask the same questions, but differ in the ordering of inhalers in their responses.
Eligibility Criteria
You may qualify if:
- \>=40 years of age at Visit 1.
- Diagnosis of COPD with a documented history of COPD for at least 6 months.
- Severity of Disease: Post albuterol/salbutamol forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio \<0.70 and FEV1 \<=70% of predicted obtained within two years of Visit 1.
- Smoking History: Current or former (defined as subjects who have quit smoking for at least 3 months prior to Screening/Visit 1) cigarette smokers with a \>10 pack-year smoking history. Number of pack years = (number of cigarettes per day/20) x number of years smoked (for example, 10 pack-years is equal to 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years).
- Current COPD Therapy:
- Currently receiving maintenance therapy with one or more long-acting bronchodilators, such as a long-acting muscarinic antagonist (LAMA; also known as a long-acting anti-cholinergic), long-acting beta 2-agonist (LABA), or inhaled corticosteroid (ICS)/LABA combination for the treatment of COPD. 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) or short acting muscarinic antagonist (SAMA) for rescue use.
- Has been on current maintenance COPD treatment for at least 4 weeks prior to Screening/Visit 1 and evaluated as unlikely to change COPD treatment within 4 weeks of Visit 1.
- 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 defined for this 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 English.
You may not qualify if:
- Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD.
- Recent experience with the ELLIPTA inhaler: Subjects who used any ELLIPTA inhaler within 6 months (180 days) prior to Visit 1.
- Recent experience with the HANDIHALER inhaler: Subjects who used any HANDIHALER inhaler within 6 months (180 days) prior to Visit 1.
- Poorly controlled COPD: Subjects with symptoms of poorly controlled COPD such as:
- Acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician, in the 4 weeks prior to Visit 1.
- Hospitalization due to acute worsening of COPD within 4 weeks of Visit 1.
- Use of a total of 8 puffs/day or more of short-acting symptom relief medications such as albuterol and ipratropium for 2 consecutive days or any 3 days within 7 days immediately preceding Visit 1.
- Changes in COPD symptoms and signs, suggesting worsening COPD health status at Visit 1.
- Other Disease Abnormalities:
- Subjects with suspected or evidence of oropharyngeal candidiasis.
- Historical or current evidence of clinically significant or rapidly progressing or unstable cardiovascular, neurological, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the analysis if the disease/condition exacerbated during the study.
- Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
- Compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures, or unable to continue their current COPD medications.
- Drug/alcohol abuse: 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.
- Drug/Food Allergy: A history of hypersensitivity to any components of the study inhaler (for example, 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (22)
GSK Investigational Site
Glendale, Arizona, 85306, United States
GSK Investigational Site
Clearwater, Florida, 33765, United States
GSK Investigational Site
Orlando, Florida, 32825, United States
GSK Investigational Site
Tampa, Florida, 33603, United States
GSK Investigational Site
Natchitoches, Louisiana, 71457, United States
GSK Investigational Site
Sunset, Louisiana, 70584, United States
GSK Investigational Site
Baltimore, Maryland, 21237, United States
GSK Investigational Site
Minneapolis, Minnesota, 55402, United States
GSK Investigational Site
Plymouth, Minnesota, 55441, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Columbus, Ohio, 43213, United States
GSK Investigational Site
Dayton, Ohio, 45419, United States
GSK Investigational Site
Anderson, South Carolina, 29621, United States
GSK Investigational Site
Charleston, South Carolina, 29406-7108, United States
GSK Investigational Site
Easley, South Carolina, 29640, United States
GSK Investigational Site
Gaffney, South Carolina, 29341, United States
GSK Investigational Site
Greenville, South Carolina, 29615, United States
GSK Investigational Site
Rock Hill, South Carolina, 29732, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Union, South Carolina, 29379, United States
GSK Investigational Site
Killeen, Texas, 76542, United States
GSK Investigational Site
Richmond, Virginia, 23225, United States
Related Publications (1)
Collison KA, Patel P, Preece AF, Stanford RH, Sharma RK, Feldman G. A Randomized Clinical Trial Comparing the ELLIPTA and HandiHaler Dry Powder Inhalers in Patients With COPD: Inhaler-Specific Attributes and Overall Patient Preference. COPD. 2018 Feb;15(1):46-50. doi: 10.1080/15412555.2017.1400000. Epub 2017 Dec 11.
PMID: 29227727DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2016
First Posted
June 1, 2016
Study Start
June 21, 2016
Primary Completion
October 4, 2016
Study Completion
October 4, 2016
Last Updated
October 15, 2018
Results First Posted
June 22, 2017
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD is available via the Clinical Study Data Request site (click on the link provided below)
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD for this study will be made available via the Clinical Study Data Request site.