An Open-label Study to Evaluate Correct Use and Ease of Use of the ELLIPTA DPI in Pediatric Subjects With Asthma



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:5 - 11
Updated:2/6/2019
Start Date:June 18, 2018
End Date:December 7, 2018

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An Open-label Study to Evaluate Correct Use and Ease of Use of the ELLIPTA Dry Powder Inhaler (DPI) in Pediatric Patients Currently Receiving Inhaled Therapy for Treatment of Their Asthma

Asthma is a chronic inflammatory disease of airways and lungs that results in
hyper-reactivity and clinically relevant episodes of wheezing. This study has been designed
to assess the correct use and ease of use of the ELLIPTA® DPI in pediatric subjects with
asthma. ELLIPTA DPI is easy to use, requires few steps, is consistent in dosing and
eliminates the hand-breath co-ordination required for metered dose inhalers (MDIs). Subjects
will be stratified by age into two strata: Stratum 1: subjects in the age group of 5 to 7
years and Stratum 2: Subjects in the age group of 8 to 11 years. All subjects will be trained
by Health care professionals (HCP) for the correct use of ELLIPTA DPI. Subjects will be given
three chances to attempt correct use of ELLIPTA DPI; subsequently, if the subject is not
successful, the parent/guardian will be able to help instruct the subject on the correct use
of the ELLIPTA DPI. The subjects who will be enrolled in the study will take placebo ELLIPTA
DPI once daily. After 28 days subjects will be randomized in 1:1 to receive a questionnaire
(Version A and B). After completion of the questionnaire on ELLIPTA DPI ease of use,
subject's ability to use ELLIPTA DPI correctly will be re-assessed. Approximately 219
subjects will be screened to participate in the study. The study will be conducted for 28
days. ELLIPTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.


Inclusion Criteria:

- Subjects between 5 and 11 years old (inclusive), at the time of the Visit 0.

- Subjects with a documented history of symptoms consistent with a diagnosis of asthma
for at least 6 months prior to V0 (includes asthma diagnosis).

- Males and premenarchial females.

- Written informed consent from at least one parent/guardian and the accompanying
informed assent from the subject (where the subject is able to provide assent) prior
to admission to the study.

- Subject and their legal guardian understand and are willing, able, and likely to
comply with study procedures and assessments.

- Subject must have been receiving asthma treatment (rescue or maintenance) for 3 months
prior to entry onto the study.

- Subject must have never been trained in correct use of, or used the ELLIPTA DPI
previously.

- Subjects must be able to demonstrate correct use of the ELLIPTA DPI after
coaching/training at Visit 1.

- Subjects must be able to converse and understand verbal instruction in English.

Exclusion Criteria:

- Subjects with concurrent diagnosis of other respiratory disorders including active
tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary
hypertension, interstitial lung diseases, cystic fibrosis or other active pulmonary
diseases.

- Subjects with concurrent diagnosis of psychiatric or psychological or any other
disorders that in the opinion of the investigator may affect the ability of the
subject to comply with study procedures or requirements.

- Subject has experienced an exacerbation which required oral/systemic corticosteroids
in the three months prior to Visit 0.

- Subject has been hospitalized for an episode of asthma within three months of Visit 0.

- Subject has had an asthmatic episode requiring intubation, associated with
hypercapnia, respiratory arrest or hypoxic seizures.

- Subject has exhibited symptoms of a recent acute respiratory tract infection within
one week of Visit 0.

- Subject has history of hypersensitivity to any components of the study inhalers
(example [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 with historical or current evidence of clinically significant or rapidly
progressing or unstable cardiovascular, neurological, renal, hepatic, immunological,
endocrine (including 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 analysis if the disease/condition exacerbated during the study.

- Parent or Guardian with a history of psychiatric disease, intellectual deficiency,
substance abuse or other condition (e.g. inability to read, comprehend or write) which
may affect: Validity of consent to participate in the study; Adequate supervision of
the subject during the study; Compliance of subject with study medication and study
procedures; subject safety and well-being.

- Subjects who have received an investigational drug and/or medical device within 30
days of entry into this study (Screening), 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
16
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Owensboro, Kentucky 42303
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Asheville, North Carolina 28803
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Austin, Texas 78705
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Aventura, Florida 33180
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Brampton, Ontario
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Columbia, Missouri 65201
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Huntington Beach, California 92647
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Little Rock, Arkansas 72205
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Miami, Florida 33136
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Minneapolis, Minnesota 55404
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Napa, California 94558
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Plantation, Florida 33324
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Plymouth, Minnesota 55441
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Rolla, Missouri 65401
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Summerville, South Carolina 29485
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Waco, Texas 76712
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Waco, TX
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