Phase IV Study in Asthma Subjects for Dry Powder Inhaler (DPI) Versus (vs) Metered Dose Inhaler (MDI) Correct Use



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:August 22, 2016
End Date:December 15, 2016

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204980: An Open-label Study to Evaluate the Correct Use of Placebo ELLIPTA™ Dry Powder Inhaler (DPI) Compared to Placebo Metered Dose Inhalers (MDI) in Subjects With Moderate Persistent Asthma

The study is conducted to evaluate the potentially improved patient handling of the ELLIPTA
Dry Powder Inhaler (DPI). Therefore, the study aims to evaluate errors encountered by subject
with asthma during handling ELLIPTA DPI relative to two metered dose inhalers (MDI), a GSK
MDI and the AstraZeneca (AZ) MDI. It is a randomised, multi-centre, open-label, cross-over
study comparing placebo ELLIPTA DPI with placebo MDI (GSK and AZ) to assess correct inhaler
use. No active drug will be used in this study in order to prevent any drug-related effects.
Approximately, 152 subjects will be randomized to receive ELLIPTA DPI inhaler and 152 will be
randomized to receive one of the MDI inhalers, for use during the first period (P)
(approximately 28 days). At Visit 2 (Day 28) all subjects previous receiving the ELLIPTA DPI
will be randomized to receive one of the MDI inhalers and all subjects who received a MDI in
the previous period will receive the ELLIPTA DPI for use during second period (approximately
28 days). Subjects will continue taking their asthma maintenance treatment and limited rescue
albuterol MDI during the entire 56-day study period.

ELLIPTA is a registered trademark of the GSK group of companies.


Inclusion Criteria:

- - Subjects aged 18 years or older, at the time of signing the informed consent

- Documented history of moderate persistent asthma

- Asthma Control Test (ACT) score >=20

- Male or Females (who are not pregnant or planning pregnancy during the study or not
lactating)

- Capable of giving signed informed consent which includes compliance with the
requirements and restrictions

- 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

- Should not have received maintenance therapy via MDI or ELLIPTA in the past six months
(DISKUS (trade name owned by GSK group of companies under license), TWISTHALER (trade
name owned by Merck Sharp & Dohme Corporation, a subsidiary of Merck & Co, under
license, etc are acceptable). Subject must be on maintenance therapy for 3 months,
have not changed dose in the month prior to inclusion and be able to continue using
their maintenance therapy throughout the study

- Requires Short-acting-beta-agonist (SABA) for symptom control =<2 days/week. Use of
SABA prior to exercise for the prevention of exercise induced bronchoconstriction is
exclusionary.

Exclusion Criteria:

- 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

- Current smokers or subjects with a smoking history of 10 pack-years or more (example,
20 cigarettes/day for 10 years) are not eligible. A subject may not have used tobacco
products within the past year (i.e., cigarettes, cigars, or pipe tobacco)

- Concurrent diagnosis of chronic obstructive pulmonary disease (COPD) or other
respiratory disorders including active tuberculosis, lung cancer, bronchiectasis,
sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or
other active pulmonary diseases

- History of life threatening asthma or has experienced more than 1 exacerbation which
required oral/systemic corticosteroids in the 12 months prior to Visit 1

- 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

- Historical or current evidence of clinically significant or rapidly progressing or
unstable cardiovascular, neurological, 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 subject
at risk through participation, or which would affect the affect the analysis if the
disease/condition exacerbated during the study

- 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

- 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
21
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San Antonio, Texas 78258
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Aventura, Florida 33180
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Baltimore, Maryland 21201
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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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Clearwater, Florida 33759
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Columbia, Missouri 65201
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Huntington Beach, California 92647
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Medford, Oregon 97504
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Miami, Florida 33136
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North Dartmouth, Massachusetts 02747
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Oklahoma City, Oklahoma 73112
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Orangeburg, South Carolina 29118
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Plymouth, Minnesota 55441
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Raleigh, North Carolina 27614
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Raleigh, NC
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Rolla, Missouri 65401
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Saint Petersburg, Florida 33713
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Spartanburg, South Carolina 29303
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Waco, Texas 76712
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Warrensburg, Missouri 64093
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Warrensburg, MO
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