Testing Tezepelumab against a placebo for asthma

Inclusion

• +Post-BD (albuterol/salbutamol) responsiveness of FEV1 ≥ 10% during ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → (15 to 30 min after administration of 4 puffs of albuterol/salbutamol with a maximum of 12 puffs of reliever medication only if tolerated by the participant) at either Visit 1 or Visit 2.
• +Written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → from (ICF) at least one parent/caregiver (as per local guidelines) and accompanying informed assent from the participant (where the participant is able to provide assent) prior to admission to the study.
• +Participants must be 5 to \< 12 years of age, at the time of signing the assent form (as applicable per local guidelines) and their caregivers signing the ICF and at Visit 3.
• +Documented physician diagnosis of severe asthma confirmed and evaluated for at least 6 months prior to Visit 1.
• +Documented physician-prescribed treatment with a total daily dose of either medium or high dose, for at least 3 months with stable dose ≥ 1 month prior to Visit 1.
• +Documented treatment with at least one additional maintenance asthma controller medication is required according to local guidelines and standard of careStandard of careThe treatment normally given for a condition outside a study.Read more →; (long-acting beta agonist, leukotriene receptor antagonist, long-acting muscarinic antagonist) for at least 3 months with stable dose ≥ 1 month prior to Visit 1.
• +Supportive evidence of asthma as documented by one of the following:
• +If (a) is not achieved at Visit 1 or Visit 2, historical documentation by any of the below prior to Visit 1:
• +Post-BD responsiveness of FEV1 ≥ 10%.
• +Positive methacholine challenge defined as provocative concentration (PC20) of ≤ 16 mg/mL.
• +PEF average daily diurnal variability \> 13% over a 2-week period.
• +Variability of FEV1 ≥ 12% between any two clinical visits.
• +Positive exercise challenge test (defined as a fall in FEV1 of \> 12%).
• +FeNO ≥ 20 ppb despite confirmed ICS maintenance therapy.
• +History of at least 2 severe asthma exacerbation events OR 1 severe asthma exacerbation event resulting in hospitalisation within 12 months prior to Visit 1.
• +Pre-BD FEV1 \>50% and ≤ 95%PN OR FEV1/forced vital capacity (FVC) ratio ≤ 0.85 at either Visit 1 or Visit 2.
• +Evidence of uncontrolled asthma, with at least 1 of the below criteria:
• +ACQ-IA score ≥ 1.5 at least once during Screening/Run-in, including Visit 3 (prior to RandomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →) for participants ≥ 6 years old at Screening.
• +Use of reliever medication, other than as a preventive for exercise induced bronchospasm, on 3 or more days per week for at least 1 week during the Screening/Run-in periodRun-in periodA short trial period before the study proper begins.Read more →.
• +Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening/Run-in period.
• +Asthma symptoms 3 or more days per week in at least 1 week during the Screening/Run-in period.
• +Body weight ≥ 16 kg at Visit 1 (Screening) and Visit 3 (Randomisation).