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:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT06364527
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 16 years
* Utilization of asthma controller therapy: inhaled corticosteroids (ICS), long-acting β2-agonists (LABAs) and/or fixed combination therapies of LABA and ICS (medium to high-dose ICS/LABA therapy)
* Use of metered dose inhaler (MDI) and / or dry powder dose inhaler (DPI) list of compatible medications is noted in section 9.2.
* FeNO ≥ 45 ppb
* Primary respiratory diagnosis of asthma
* Patients with uncontrolled, moderate-to-severe asthma
* Non-smoker
* Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in consent form and protocol.
* Subject understands and is willing, able, and likely to comply with study procedures and restrictions
* Willingness to participate in this study and to use the Aptar Digital Health technology
* Willingness to share information / data with Aptar Digital Health (through informed consent)
Access to technology
* Access to a smartphone (requirements Android ≥13 and iOS ≥16
* Ability to use smartphone (smartphone usability assessment to be provided by Aptar Digital Health)
* Access to a current email account
* Access to data / Wi-Fi
Exclusion Criteria:
* Age \< 16 years
* FeNO \< 45 ppb
* Known or suspected alcohol or drug abuse which in opinion of investigator could interfere with subject's proper completion of the protocol requirement
* History of life-threatening asthma: Defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within last 6 months
* A lower respiratory tract infection within 7 days of the screening visit
* Concurrent diagnosis of chronic obstructive pulmonary disease (COPD) or other respiratory disorders including active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases.
* History of hypersensitivity/intolerance to any components of the study inhalers (example, 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.
* Ever received treatment with biological based therapy example, omalizumab, mepolizumab, for asthma.
* 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
* An immediate family member of the participating investigator, sub-investigator, study coordinator, employee of the participating investigator, or any family member of a Aptar Pharma, Aptar Digital Health, Voluntis, or Cohero employee.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT06364527
Study Brief:
Protocol Section:
NCT06364527