Breath test device could change how asthma is monitored at home

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria Uncontrolled Cohort: 1. The subject is male or female age 5 years and above 2. The subject and/or their Legally Authorized Representative (LAR) in the case of a minor has signed an Informed Consent Form (ICF) and Assent (as applicable per IRB requirements) and understands the risks and benefits of the study 3. The subject has a diagnosis of asthma 4. The subject is willing and able to perform all study procedures 5. The subject must have uncontrolled asthma as defined by the presence on at least 2 days per week (can be non-consecutive days) in the 7 days prior to V1 of at least 3 symptoms from the following list: i. Cough ii. Wheezing iii. Shortness of breath iv. Chest tightness v. Nocturnal awakening with asthma vi. Limitation in activity due to asthma 6. The subject has a FeNO value based on the first measurement of at least 30 ppb if an adult or at least 25 ppb if \<18 years old measured on a cleared FeNO device (e.g., NIOX VERO®) Inclusion Criteria Controlled Cohort: 1. The subject is male or female age 5 years and above 2. The subject and/or their Legally Authorized Representative (LAR) in the case of a minor has signed an Informed Consent Form (ICF) and Assent (as applicable per IRB requirements) and understands the risks and benefits of the study 3. The subject has an established diagnosis of asthma for at least 180 days prior to V1 4. The subject is willing and able to perform all study procedures Exclusion Criteria Uncontrolled: 1. The subject is in need of immediate referral to the emergency department 2. The subject has taken the following medications in the indicated period before V1: 1. OCS within 4 weeks 2. ICS within 2 weeks 3. Biologic therapies (e.g., omalizumab or dupilumab) within 12 weeks. Note: Use of as needed ICS+SABA is also exclusionary in the 2 weeks prior to V1 3. The subject has a contraindication to corticosteroids. 4. The subject has demonstrated significant non-compliance during a previous clinical trial 5. The subject participated in any clinical study involving a drug, biologic, or device within 30 days prior to V1 or within 5 half-lives for drugs, whichever duration is shorter 6. The subject has other significant respiratory conditions, e.g., Chronic Obstructive Pulmonary Disease, cystic fibrosis 7. Subject is an employee/relative of the following: 1. Biometry Inc. 2. Contract Research Organization(s) running the study 3. Investigational Site 4. Study Vendors 8. Any other condition(s), that in the Investigator's opinion, make it undesirable for the subject to participate in the study 9. A ≥ 10 pack-year history of smoking or smoking in the 180 days prior to V1 (pack years = average packs/day x years of exposure) Note: smoking includes cigarettes, electronic cigarettes, cigars, and chewing or dipping tobacco 10. Pregnant or nursing subjects Exclusion Criteria Controlled: 1. The subject has other significant respiratory conditions, e.g., Chronic Obstructive Pulmonary Disease, cystic fibrosis 2. The subject has demonstrated significant non-compliance during a previous clinical trial 3. The subject participated in any clinical study involving a drug, biologic, or device within 30 days prior to V1 or within 5 half-lives for drugs, whichever duration is shorter. 4. Subject is an employee/relative of the following: 1. Biometry Inc. 2. Contract Research Organization(s) running the study 3. Investigational Site 4. Study Vendors 5. Any other condition(s), that in the Investigator's opinion, make it undesirable for the subject to participate in the study 6. A ≥ 10 pack-year history of smoking or smoking in the 180 days prior to V1 (pack years = average packs/day x years of exposure) Note: smoking includes cigarettes, electronic cigarettes, cigars, and chewing or dipping tobacco 7. Pregnant or nursing subjects