Phase 3 Asthma Trial, Recruiting

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

Who might be able to join this trial:

• Children aged 6 years old up to (but not including) 12 years old at the time of joining the trial
• Children who have had a confirmed asthma diagnosis for at least 12 months before enrolling in the study
• Children whose parent or legal guardian is willing and able to attend all study visits and help the child follow the study requirements, including giving the study medication and completing a daily diary (at least 70% of the time in the last 2 weeks of a lead-in period)
• Children who have asthma symptoms that are not fully controlled, measured by a specific asthma symptom score (called ACQ-IA) at certain points during the study
• Children currently on a low daily dose of an inhaled corticosteroid (a common asthma preventer medication), either alone or with one additional controller medication, who can transition to a single low-dose inhaled corticosteroid during the lead-in period
• Children whose lung function test result (called FEV1) is at least 50% of what would be expected for their age and size, at two specific points during the study
• Children whose lungs show a meaningful improvement in the breathing test after using a reliever inhaler (salbutamol/albuterol), either at the lead-in visit or based on documented historical results
• Children (and their parent or guardian) who are able to use the specific study inhaler device (called Breezhaler®) correctly, use other study devices, and complete breathing tests
• Children who have a negative COVID-19 test result (PCR or antigen) within 3 days before the randomisation visit (the visit where participants are assigned to a treatment group)
• A parent or legal guardian must sign a consent form on behalf of the child, and the child must also agree to participate as required by local rules
• For an optional blood sampling part of the study: children who weigh at least 25 kg may be eligible to take part in this optional component

Who may not be able to join:

• Children who have ever been placed on a breathing machine (intubated) due to asthma
• Children who have had a severe asthma attack in the past month that required steroid tablets or injections, a hospital stay longer than 24 hours, or an emergency department visit within 24 hours
• Children who have had a respiratory tract infection (such as a chest or throat infection) within 4 weeks before the first study visit, or between the first visit and the randomisation visit (a one-time rescreening may be possible 4 weeks after recovery)
• Children who have any other ongoing lung or breathing condition besides asthma, such as cystic fibrosis, COPD, sarcoidosis, active tuberculosis, or certain lung infections
• Children who have recently used certain medications that have not been washed out of the system for the required period before the study begins (confirm specific medications with the trial site)
• Children who have taken other experimental (investigational) drugs within 30 days before enrolling, or within 5 half-lives of that drug — whichever period is longer
• Children who have or have had a cancer diagnosis in the past 5 years (with the exception of certain very localised skin or cervical conditions — confirm with trial site)
• Children with known significant kidney problems, signs of urinary blockage, inherited kidney conditions affecting kidney function, or a kidney function score below a specific threshold
• Children who have a known history of a heart rhythm condition called long QT syndrome, or whose heart rhythm measurement (QTc) is at or above 450 milliseconds, confirmed by a central reviewer
• Children who have a clinically significant abnormal heart tracing (ECG) result before the randomisation visit
• Children who have significantly abnormal blood test results or abnormal liver function results before the randomisation visit
• Children with a visible mouth or throat fungal infection (called oral thrush/candidiasis) at or before the randomisation visit (rescreening may be possible once the infection has been treated and cleared)
• Children currently receiving long-acting muscarinic antagonist (LAMA) medication as a regular asthma treatment within 3 months before screening
• Children who have been treated with long-acting theophylline within 4 weeks before screening, or short-acting theophylline within 2 weeks before screening
• Children who have used non-approved experimental asthma treatments within 4 weeks before the first study visit
• Children who have a known allergy or sensitivity to any of the study medications or their ingredients, including fluticasone propionate, indacaterol, mometasone, budesonide, salmeterol, albuterol, or lactose
• Children with Type 1 diabetes, or Type 2 diabetes that is not well controlled
• Children who have started allergy immunotherapy (desensitisation treatment) within 3 months before the lead-in visit, or where the dose is expected to change during the study
• Children with any surgical history or medical condition that could significantly affect how the study drug is processed by the body
• Children who, in the investigator's opinion, are unlikely to be able to follow the study requirements, or for whom participation could pose a safety risk
• Children who are close family members of any staff involved in running the study at that site
• Female children who have started their menstrual periods (or who do so during the study) and who do not agree to abstinence or an accepted form of contraception as defined in the study protocol

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