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:
2025-12-26 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 2:41 PM
NCT ID:
NCT02586506
Eligibility Criteria:
Inclusion Criteria:
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
* Age: \>=18 years of age at Screening at Visit 1
* Diagnosis: Asthma as defined by the National Institutes of Health
* Reversibility of Disease: Demonstrated historical reversibility of \>=12% and \>=200 millilitre (mL) reversibility of Forced Expiratory Volume in One Second (FEV1) within 10-40 minutes following 2-4 inhalations of albuterol inhalation aerosol (or equivalent nebulized treatment with albuterol solution) within 24 months of Visit 1
* Current asthma Therapy: Currently receiving maintenance (with one or more of the following therapies: e.g. inhaled corticosteroid alone or in combination with long-acting bronchodilators, such as long-acting beta 2-agonist \[LABA\]) inhaler therapy (with no prior or ongoing use of ELLIPTA inhaler) for the treatment of asthma. Subjects must be able to continue using their currently prescribed asthma maintenance inhaler therapy throughout the study and as needed short acting betaadrenergic agonist (SABA) for rescue use.
* Ability to Use Inhalers: Subject must be able to demonstrate correct use of ELLIPTA inhaler within three attempts at Visit 1.
* Males
* Females who are not pregnant or not planning a pregnancy during the study or not lactating.
* Capable of giving signed and dated written informed consent as described in protocol which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
* Subject understands and is willing, able, and likely to comply with study procedures and restrictions.
* Subject must be able to read, comprehend, and record information in English.
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply
* Chronic Obstructive Pulmonary Disease (COPD): Subjects with a current diagnosis of COPD.
* Asthma medications:
Receiving only inhaled short-acting beta-adrenergic agonists, i.e., albuterol as their daily asthma therapy (as needed \[prn\] or regularly scheduled).
Has changed maintenance asthma treatment within 4 weeks prior to Screening/Visit 1 or plans to change asthma treatment within 4 weeks of Visit 1.
* Asthma/Exacerbations/Hospitalization:
Any asthma exacerbation, defined as deterioration of asthma requiring the use of systemic corticosteroids (oral, parenteral or depot) within 4 weeks of Visit 1. A subject must not have any hospitalisation or emergency department visit due to asthma within 3 months of Visit 1.
Subjects with poorly controlled or who have unstable asthma, in the investigator's judgment that would affect subject's ability to evaluate "ease of use and correct use".
History of life-threatening asthma, defined an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
* Other Respiratory Disorders: Subjects with other respiratory disorders, including active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, or pulmonary disease (including, but not confined to chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, bronchopulmonary dysplasia, and chronic obstructive pulmonary disease), interstitial lung diseases or other active pulmonary diseases.
* Other Disease Abnormalities:
Historical or current evidence of clinically significant or rapidly progressing or unstable cardiovascular, neurological, cardiovascular, neurological, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological 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 affect the analysis if the disease/condition exacerbated during the study.
Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
* Oropharyngeal Examination: Subjects with clinical visual evidence of oral candidiasis at Visit 1 are not eligible.
* Compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures, or unable to continue their current asthma medications.
* Tobacco Use: Current smokers or subjects with a smoking history of 10 pack-years or more (e.g., 20 cigarettes/day for 10 years) are not eligible. A subject may not have used tobacco products within the past year (i.e., cigarettes, cigars, or pipe tobacco).
* Alcohol and Drug Abuse A known or suspected history of alcohol or drug abuse within the last 2 years.
* A history of hypersensitivity to any components of the study inhaler (e.g., lactose, magnesium stearate). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates participation will also be excluded.
* Prior or Ongoing use of the ELLIPTA inhaler (including both investigational and commercially available product).
* Investigational Product: Subjects who have received an investigational drug and/or medical device/inhaler within 30 days of entry into this study (Screening/Visit 1), or within five drug half-lives of the investigational drug, whichever is longer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02586506
Study Brief:
Protocol Section:
NCT02586506