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

NCT ID: NCT03478657

Last Updated: 2021-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-18
• Study Completion Date: 2018-12-07

Brief Summary

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.

Conditions

Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects using placebo ELLIPTA DPI

Subjects in stratum 1 and stratum 2 will be of age group from 5 to 7 years and 8 to 11 years respectively. Subjects will take placebo ELLIPTA DPI once daily. During Visit 2 (Day 28) subjects will be randomized to receive questionnaire on ELLIPTA DPI usage either version A or B.

Group Type: EXPERIMENTAL

Placebo DPI

Intervention Type: DRUG

Subjects will receive placebo via oral inhalation route using ELLIPTA once daily. Placebo DPI will be available in two strips of 30 blisters per strip. First strip will contain lactose monohydrate and second strip will have lactose monohydrate blended with magnesium stearate.

ELLIPTA DPI

Intervention Type: DEVICE

Subjects will receive placebo DPI via ELLIPTA. ELLIPTA is trademark of GSK

Ease of use questionnaires

Intervention Type: OTHER

Subjects from both stratum after use of ELLIPTA DPI will be randomized to receive either version A or B of the questionnaires. Subjects will be asked questions on ease of use of ELLIPTA. Parent/guardian will also complete a questionnaire about the ELLIPTA DPI.

Interventions

Placebo DPI

Subjects will receive placebo via oral inhalation route using ELLIPTA once daily. Placebo DPI will be available in two strips of 30 blisters per strip. First strip will contain lactose monohydrate and second strip will have lactose monohydrate blended with magnesium stearate.

Intervention Type: DRUG

ELLIPTA DPI

Subjects will receive placebo DPI via ELLIPTA. ELLIPTA is trademark of GSK

Intervention Type: DEVICE

Ease of use questionnaires

Subjects from both stratum after use of ELLIPTA DPI will be randomized to receive either version A or B of the questionnaires. Subjects will be asked questions on ease of use of ELLIPTA. Parent/guardian will also complete a questionnaire about the ELLIPTA DPI.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

Napa, California, United States

GSK Investigational Site

Aventura, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Plantation, Florida, United States

GSK Investigational Site

Owensboro, Kentucky, United States

GSK Investigational Site

Minneapolis, Minnesota, United States

GSK Investigational Site

Plymouth, Minnesota, United States

GSK Investigational Site

Columbia, Missouri, United States

GSK Investigational Site

Rolla, Missouri, United States

GSK Investigational Site

Asheville, North Carolina, United States

GSK Investigational Site

Summerville, South Carolina, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Waco, Texas, United States

GSK Investigational Site

Brampton, Ontario, Canada

GSK Investigational Site

Burlington, Ontario, Canada

GSK Investigational Site

London, Ontario, Canada

GSK Investigational Site

Windsor, Ontario, Canada

Countries

United States; Canada

References

Halverson P, Liem J, Heyes L, Preece A, Bareille P, Rees J, Jain R, Stanford RH, Lenney W, Collison K, Sharma R. The evaluation of the correct use and ease-of use of the ELLIPTA DPI in children with asthma. Pediatr Pulmonol. 2021 Jan;56(1):57-64. doi: 10.1002/ppul.25149. Epub 2020 Nov 19.

Reference Type: DERIVED

PMID: 33124762 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217381&parentIdentifier=206924&attachmentIdentifier=b4321234-3409-4cf7-b77d-c77242ab6a9f&fileName=gsk-206924-protocol-redact.pdf&versionIdentifier=

206924 Full Protocol

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217381&parentIdentifier=206924&attachmentIdentifier=f5465b2a-409b-445e-bc96-fe3671501308&fileName=gsk-206924-reporting-and-analysis-plan-redact.pdf&versionIdentifier=

206924 Statistical Analysis Plan (SAP)

Other Identifiers

206924

Identifier Type: -

Identifier Source: org_study_id