A study to investigate the efficacy and safety of tezepelumab compared with placebo in children 5 to < 12 years old with severe asthma
- Conditions
- Severe Uncontrolled AsthmaAsthma (an illness that causes breathing difficulty) that is not fully controlled, so that asthma attacks are still occurring despite the use of other available treatmentsMedDRA version: 20.0Level: PTClassification code: 10003553Term: Asthma Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- CTIS2022-502984-39-00
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 372
Documented physician-prescribed treatment with a total daily dose of either medium or high dose ICS, and additional asthma controller medication (i.e., long-acting ß2 agonist, leukotriene receptor antagonist, long acting muscarinic antagonist) for at least 3 months with stable dose = 1 month prior to Visit 1., Evidence of asthma as documented by one of the following: (a) Documented historical BD responsiveness of FEV1 = 10% in the previous 12 months prior to Visit 1 OR (b) Documented historical methacholine challenge result of = 16mg/mL in the previous 12 months prior to Visit 1 OR (c) Post-BD (albuterol/salbutamol) responsiveness of FEV1 = 10%during Screening (15 to 30 min after administration of 4 puffs of albuterol/salbutamol) at either Visit 1 or Visit 2., History of at least 2 severe asthma exacerbation events resulting in treatment with a systemic corticosteroid (oral or parenteral) OR 1 severe asthma exacerbation event resulting in hospitalization within 12 months prior to Visit 1., Pre-BD FEV-1 >50% and = 95%PN OR FEV1/FVC ratio = 0.8 at either Visit 1 or Visit 2., Evidence of uncontrolled asthma, with at least 1 of the below criteria: (a) ACQ-IA score = 1.5 at least once during Screening/Run-in, including Visit 3 (prior to Randomisation) for participants = 6years old at Screening (b) 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 period (c) Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening/Run-in period (d) 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)., 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 for at least 6 months prior to Visit 1.
History of cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyposis., History of any clinically significant disease or disorder other than asthma which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant’s ability to participate in the study., History of a life-threatening asthma exacerbation resulting in a hypoxic seizure or requiring intubation or mechanical ventilation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method