Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT03478657
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
11 Years
Study:
NCT03478657
Study Brief:
Protocol Section:
NCT03478657