Phase 2 Asthma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have a confirmed diagnosis of asthma that was made by a doctor.
• People who have been regularly and consistently using an inhaled corticosteroid (a type of preventer inhaler) plus one other asthma controller medication.
• People whose Childhood Asthma Control Test score is 19 or higher (this is a questionnaire used to measure how well asthma is being controlled).
• People whose lung function test result (called FEV1, which measures how much air can be breathed out) is 95% or less of what would be expected for their age and size.
• People whose body weight is at least 14 kg and whose Body Mass Index (BMI) falls at or below the 95th percentile for their age.
• Female participants who have started their menstrual period must have a negative urine pregnancy test result.
• People who have not used any asthma medications other than the trial's specified inhaler (BFF MDI, taken twice daily) and a reliever inhaler (albuterol/salbutamol) used only when needed.

Who may not be able to join:

• People who have had a severe, life-threatening asthma episode in the past, such as one that required a breathing tube, caused a seizure due to low oxygen, or led to a loss of consciousness related to asthma.
• People who have a significant ongoing or past medical condition affecting the heart, liver, kidneys, blood, nervous system, hormones, digestive system, or lungs (other than asthma).
• People who have abnormal results in physical examinations, blood tests, heart trace (ECG), or vital signs that are considered medically significant.
• People who have been hospitalised because of asthma.
• People who have a type of eye condition called narrow-angle glaucoma that is not well managed, unexplained changes in vision, bladder problems, difficulty urinating, or other conditions where a type of medication called an anticholinergic would not be considered safe (confirm with trial site).
• People who currently use a type of inhaled medication called a long-acting muscarinic antagonist (LAMA), whether on its own or as part of a combination inhaler.
• People who are currently taking beta-blocker medications in tablet or other systemic (whole-body) form.
• People who have had a respiratory infection that required antibiotic treatment.
• People who have used corticosteroid medications taken by mouth or injection (systemic corticosteroids) for any reason, including for an asthma flare-up.
• People who have a known allergy or sensitivity to beta 2-agonists, corticosteroids, anticholinergics, or any ingredient in the trial inhaler.
• People who, for medical reasons, are unable to stop using their short-acting reliever inhaler or other asthma medications as required by the trial.
• People who have used or are currently using biologic medications — such as omalizumab, mepolizumab, benralizumab, or reslizumab — or any investigational biologic treatment.
• People who regularly use a nebuliser machine to take their asthma medications at home.
• People who are using any medications that affect or suppress the immune system.

Important: Always verify eligibility with the trial site directly before applying.