Last updated: 07/17/2024 17:32:31
An open-label study to evaluate correct use and ease of use of the ELLIPTA DPI in pediatric subjects with asthma
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: 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, for two more attempts. 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Percentage of subjects from stratum 1 with correct use of ELLIPTA DPI
Timeframe: Day 28
Percentage of subjects from stratum 2 with correct use of ELLIPTA DPI
Timeframe: Day 28
Percentage of subjects from stratum 1 who rate ELLIPTA DPI as easy to use
Timeframe: Day 28
Percentage of subjects from stratum 2 who rate ELLIPTA DPI as easy to use
Timeframe: Day 28
Secondary outcomes:
Percentage of subjects from stratum 1 with correct use of ELLIPTA DPI after initial training from HCP
Timeframe: Day 1
Percentage of subjects from stratum 2 with correct use of ELLIPTA DPI after initial training from HCP
Timeframe: Day 1
Percentage of subjects with correct use of ELLIPTA DPI
Timeframe: Day 28
Percentage of subjects who rate the ELLIPTA DPI as easy to use
Timeframe: Day 28
Percentage of subjects from stratum 1 with at least one critical error during the use of ELLIPTA DPI
Timeframe: Day 1
Percentage of subjects from stratum 2 with at least one critical error during the use of ELLIPTA DPI
Timeframe: Day 1
Interventions:
Drug: Placebo DPI
Device: ELLIPTA DPI
Other: Ease of use questionnaires
Enrollment:
222
Observational study model:
Not applicable
Primary completion date:
2018-07-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
June 2018 to December 2018
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
5 - 11 years
Accepts healthy volunteers
No
- 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).
- 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.
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Asheville, North Carolina, United States, 28801
Status
Study Complete
Location
GSK Investigational Site
Austin, Texas, United States, 78759-8950
Status
Study Complete
Location
GSK Investigational Site
Aventura, Florida, United States, 33180
Status
Study Complete
Location
GSK Investigational Site
Columbia, Missouri, United States, 65203
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92648
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
Status
Study Complete
Location
GSK Investigational Site
Napa, California, United States, 94558
Status
Study Complete
Location
GSK Investigational Site
Owensboro, Kentucky, United States, 42301
Status
Study Complete
Location
GSK Investigational Site
Plantation, Florida, United States, 33324
Status
Study Complete
Location
GSK Investigational Site
Plymouth, Minnesota, United States, 55441
Status
Study Complete
Location
GSK Investigational Site
Summerville, South Carolina, United States, 29485
Status
Study Complete
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2018-07-12
Actual study completion date
2018-07-12
Plain language summaries
Summary of results in plain language
Available language(s): English
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Participate in clinical trial
Additional information
206924 Full Protocol
Click here206924 Statistical Analysis Plan (SAP)
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