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:

• A parent or caregiver must give written permission for the child to take part, and the child must also agree to join if they are old enough to do so.
• The child must be between 5 and just under 12 years old at the time consent is signed and at the start of the trial.
• The child must have a formal diagnosis of severe asthma from a doctor, confirmed and monitored for at least 6 months before the first visit.
• The child must have been prescribed a medium or high daily dose of inhaled corticosteroid (a preventer inhaler) for at least 3 months, with the dose unchanged for at least 1 month before the first visit.
• The child must also be taking at least one other regular asthma preventer medication (such as a long-acting reliever, a leukotriene modifier, or a long-acting muscarinic blocker) for at least 3 months, with the dose unchanged for at least 1 month before the first visit.
• There must be medical evidence supporting the asthma diagnosis, shown by one of several breathing tests or measurements taken during screening or recorded previously (confirm with trial site for which test applies).
• The child must have had at least 2 serious asthma attacks in the past 12 months, or at least 1 serious attack that required a hospital stay.
• Breathing test results must fall within a specific range at the first or second visit (confirm with trial site for exact values).
• The child's asthma must currently be poorly controlled, shown by at least one of the following: a symptom score above a set level, needing reliever medication on 3 or more days per week for at least a week, waking from sleep due to asthma symptoms at least once during the screening period, or having asthma symptoms on 3 or more days per week for at least one week during screening.
• The child must weigh at least 16 kg at both the first and the randomisation visit.

Who may not be able to join:

• Children with a history of vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyps.
• Children with any other significant medical condition that, in the investigator's opinion, could put the child at risk or affect the trial results.
• Children who had a significant worsening of asthma or a serious asthma attack requiring oral steroids or an increased steroid dose within 30 days before the first visit.
• Children whose inhaled corticosteroid dose was changed within 1 month before the first visit.
• Children who have had a life-threatening asthma attack that caused a seizure from low oxygen levels or required a breathing tube.

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