Preference Attributes of ELLIPTA Dry Powder Inhaler (DPI) and HANDIHALER DPI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:10/17/2018
Start Date:June 21, 2016
End Date:October 4, 2016

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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)

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.


Inclusion Criteria:

- >=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:

1. 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.

2. 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.

Exclusion Criteria:

- 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:

1. 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.

2. Hospitalization due to acute worsening of COPD within 4 weeks of Visit 1.

3. 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.

4. Changes in COPD symptoms and signs, suggesting worsening COPD health status at
Visit 1.

- Other Disease Abnormalities:

1. Subjects with suspected or evidence of oropharyngeal candidiasis.

2. 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.

3. 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.

- Investigational Product: 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.

- Affiliation with Investigator's Site: A subject will not be eligible for this study if
he/she is an immediate family member of the participating investigator,
sub-investigator, study coordinator, or employee of the participating investigator.
We found this trial at
22
sites
Baltimore, Maryland 21201
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Anderson, South Carolina 29621
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Charleston, South Carolina 29425
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Cincinnati, Ohio 45229
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Clearwater, Florida 33759
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Columbus, Ohio 43219
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Dayton, Ohio 45420
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Dayton, OH
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Easley, South Carolina 29640
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Easley, SC
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Gaffney, South Carolina 29340
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Glendale, Arizona 85304
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Greenville, South Carolina 29615
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Killeen, Texas 76543
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Minneapolis, Minnesota 55404
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Natchitoches, Louisiana 71457
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Orlando, Florida 32806
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Plymouth, Minnesota 55441
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Richmond, Virginia 23298
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Rock Hill, South Carolina 29732
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Rock Hill, SC
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Spartanburg, South Carolina 29303
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Sunset, Louisiana 70584
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Tampa, Florida 33612
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Union, South Carolina 29379
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Union, SC
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