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
Overview
- Phase
- Phase 4
- Intervention
- Placebo DPI
- Conditions
- Asthma
- Sponsor
- GlaxoSmithKline
- Enrollment
- 222
- Locations
- 1
- Primary Endpoint
- Percentage of Participants From Each Stratum Who Demonstrated Correct Use of the ELLIPTA DPI at Visit 2, Attempt 1 (Day 28)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects between 5 and 11 years old (inclusive), at the time of the Visit
- •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
- •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
- •Subject has been hospitalized for an episode of asthma within three months of Visit
- •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
- •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.
Arms & Interventions
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.
Intervention: Placebo DPI
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.
Intervention: ELLIPTA DPI
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.
Intervention: Ease of use questionnaires
Outcomes
Primary Outcomes
Percentage of Participants From Each Stratum Who Demonstrated Correct Use of the ELLIPTA DPI at Visit 2, Attempt 1 (Day 28)
Time Frame: At Day 28
Participants were trained in the correct use of ELLIPTA DPI by a healthcare professional (HCP) on Day 1 (Visit 1) following which eligible participants were required to take one inhalation of placebo from the ELLIPTA DPI once daily for 28 days. At Day 28 (Visit 2), participants were administered a questionnaire on ease of use of ELLIPTA DPI. Participants and their parents/guardian were required to complete the questionnaire, following which participants were assessed for their ability to demonstrate correct use of ELLIPTA DPI (1 attempt with no training or instruction and then 1 attempt after instruction from parent/guardian). Percentage of participants who demonstrated correct use of ELLIPTA was calculated as "number of participants who demonstrated correct use at Visit 2" divided by "number of participants whose use of the ELLIPTA DPI was evaluated at Visit 2" multiplied by 100. The 95% confidence interval (CI) was calculated using the exact binomial distribution.
Percentage of Participants Who Rated the ELLIPTA DPI as Easy to Use Among Those Who Could Demonstrate Correct Use at Visit 2, Attempt 1 (Day 28)
Time Frame: At Day 28
Participants were trained in the correct use of ELLIPTA DPI at Visit 1 by the HCP and eligible participants were required to take one inhalation of placebo from the ELLIPTA DPI once daily for 28 days. At Day 28 (Visit 2), participants were administered a questionnaire on the ease of use of ELLIPTA DPI. For participants in Stratum 1, questionnaire was provided to the interviewer and responses were recorded. For Stratum 2, the questionnaire was self-administered (or interviewer administered, if participant was unable to self-administer). Percentage of participants who rated the ELLIPTA DPI as easy to use was calculated as "number of participants who rate the ELLIPTA as easy" divided by "number of participants who demonstrated correct use at Visit 2 (Attempt #1)" multiplied by 100. The 95% CI for the percentages are calculated using the exact binomial distribution.
Secondary Outcomes
- Percentage of Participants Who Demonstrated Correct Use of the ELLIPTA DPI at Visit 2, Attempt 1 in All Participants (Stratum 1+Stratum 2)(At Day 28)
- Percentage of Participants From Each Stratum Who Demonstrated Correct Use of the ELLIPTA DPI at Visit 1, Attempt 1 (Day 1)(Day 1)
- Percentage of Participants Who Rated Easy Use of ELLIPTA DPI at Visit 2 in All Participants (Stratum 1+Stratum 2)(At Day 28)
- Percentage of Participants Who Reported at Least One Critical Error From Each Stratum With the Use of ELLIPTA DPI at Visit 1, Attempt 1(Day 1)