Comparative Study of ELLIPTA Dry Powder Inhaler (DPI) Versus DISKUS DPI Used With 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:2/24/2018
Start Date:September 20, 2017
End Date:January 5, 2018

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A Randomized, Open-label, Cross-over, Placebo Inhaler Study to Evaluate the Correct Use of ELLIPTA™ Dry Powder Inhaler (DPI) Compared to DISKUS™ DPI Used in Combination With HandiHaler DPI in Participants With Chronic Obstructive Pulmonary Disease (COPD)

This randomized, cross over study aims to find out the benefits of delivering triple therapy
using a single ELLIPTA® DPI (fixed-dose combination triple therapy) versus delivering triple
therapy using two different types of inhalers (open triple therapy) including DISKUS® with
HandiHaler® to subjects with COPD. Correct inhaler use, critical errors and performance
attributes will also be assessed. Approximately 240 subjects with COPD will be randomized in
the study. The study will be conducted in 3 visits and will be completed in approximately 56
days. At Visit 1 (Day 1) and Visit 2 (Day 28) subjects will be randomized to receive a
placebo ELLIPTA inhaler once daily (QD) or a placebo DISKUS twice daily (BID) with placebo
HandiHaler QD inhaler in 1:1 ratio in a cross-over manner for the study period (28 days for
each period). At Visit 3 (Day 56), subjects will be asked to complete preference
questionnaire 1 or 2. There will be no active treatment and subjects will continue to take
their own prescribed COPD maintenance and rescue medication during the entire study period.
ELLIPTA and DISKUS are the registered trademarks of GlaxoSmithKline group of companies.
HandiHaler is the registered trademark of Boehringer Ingelheim group of companies.


Inclusion Criteria:

- Subjects must be capable of giving signed informed consent.

- Subjects must have a diagnosis of COPD with a documented history of COPD for at least
12 months, in accordance with the definition by the American Thoracic Society/European
Respiratory Society.

- Subjects must be 40 years of age inclusive, at the time of signing the informed
consent.

- Male or female subjects will be included. Females must not be pregnant or planning
pregnancy during the study or not lactating.

- Subjects must have a documented post albuterol 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.

- 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
(example, 10 pack-years is equal to 20 cigarettes per day for 10 years, or 10
cigarettes per day for 20 years].

- All subjects should be currently receiving maintenance treatment for COPD for at least
4 weeks prior to Randomization/Visit 1 and evaluated as unlikely to change COPD
treatment within 4 weeks of Visit 1.

- All subjects should be able to stay on their prescribed maintenance COPD inhaler (s)
without change throughout the entire treatment period.

- Subjects must be able to read, comprehend, and record information in English.

Exclusion Criteria:

- Subjects must not have a current diagnosis of asthma.

- Subjects must not have used the ELLIPTA, DISKUS, or HandiHaler inhalers in the 12
months prior to Visit 1.

- Subjects must not be receiving their current COPD medications with the ELLIPTA,
DISKUS, or HandiHaler inhalers.

- Subjects must not be receiving only inhaled short-acting beta-adrenergic agonists,
i.e., albuterol as their daily COPD therapy (as needed or regularly scheduled).

- Subjects must not have experienced more than 1 COPD exacerbation which required
hospitalization in the 12 months prior to Visit 1.

- Subjects must not have a known or suspected history of alcohol or drug abuse within
the last 2 years.

- Subjects must not have a history of hypersensitivity to any component of the study
inhalers (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.

- Subjects with other respiratory disorders, including active tuberculosis, active lung
cancer, sarcoidosis, lung fibrosis, pulmonary hypertension, or pulmonary disease
(including but not confined to asthma, bronchiectasis with the need for treatment,
cystic fibrosis, and bronchopulmonary dysplasia), interstitial lung diseases or other
active pulmonary diseases.

- Subjects with 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 hematological
abnormalities that are uncontrolled. Significant is defined as any disease that, in
the opinion of the investigator, would put the safety of the participant at risk
through participation, or which would affect the analysis if the disease/condition
exacerbated during the study will be excluded.

- Subjects with history of psychiatric disease, intellectual impairment, poor motivation
or other conditions that will limit the validity of informed consent to participate in
the study will be excluded.

- Subjects at risk of non-compliance, or unable to comply with the study procedures, or
unable to continue their current medications.

- Subjects who have received an investigational drug and/or medical device/inhaler
within 30 days of entry into this study (Screening/Visit 1), or within five drug
half-lives of the investigational drug, whichever is longer.

- Subjects 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.
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Spartanburg, South Carolina 29303
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Anderson, South Carolina 29621
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Canton, Ohio 44708
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Charlotte, North Carolina 28203
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Cincinnati, Ohio 45229
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Dayton, Ohio 45420
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Gastonia, North Carolina 28054
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Greenville, South Carolina 29615
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Medford, Oregon 97504
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Monroe, North Carolina 28112
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Mooresville, North Carolina 28117
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Natchitoches, Louisiana 71457
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Oklahoma City, Oklahoma 73112
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Orlando, Florida 32806
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Richmond, Virginia 23298
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Rock Hill, South Carolina 29732
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Saint Charles, Missouri 63301
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Saint Charles, MO
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