Study to Evaluate Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma
- Registration Number
- NCT05274815
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is a study designed to evaluate efficacy and safety of Tezepelumab in reducing oral corticosteroid use in adult patients with severe asthma who are receiving oral corticosteroids with or without additional asthma controller medications.
- Detailed Description
This is a multicentre, single-arm, phase 3b study designed to evaluate efficacy and safety of reducing daily oral corticosteroid use after initiation of 210 mg dose of Tezepelumab administered subcutaneously in patients with severe asthma receiving high-dose inhaled corticosteroid plus long-acting β2 agonist and oral corticosteroids with or without additional asthma controller medications.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 306
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tezepelumab Tezepelumab Tezepelumab subcutaneous injection
- Primary Outcome Measures
Name Time Method Proportion of participants who reduced daily prescribed maintenance OCS dose to ≤ 5 mg/day without loss of asthma control At Week 52 Proportion of participants who reduced daily prescribed maintenance OCS dose to ≤ 5 mg/day without loss of asthma control at Week 52.
Proportion of participants who discontinued OCS without loss of asthma control At Week 52 Proportion of participants who discontinued OCS without loss of asthma control at Week 52.
- Secondary Outcome Measures
Name Time Method Proportion of participants who did not experience an exacerbation associated with hospitalisation or ER visit Baseline to Week 52 Proportion of participants who did not experience an exacerbation associated with hospitalization or ER visit over 52 weeks.
Proportion of participants with ≥ 50% reduction from baseline in daily maintenance OCS dose Baseline to Week 52 Proportion of participants with ≥ 50% reduction from baseline in daily maintenance OCS dose at Week 52. Percent change from baseline is defined as {(final dose-baseline dose)/baseline dose}\*100.
Rate of asthma exacerbation associated with hospitalisation Baseline to Week 52 Rate of asthma exacerbation is based on exacerbations reported by the investigator in eCRF that are associated with a hospitalization over 52 weeks.
Proportion of participants who did not experience an exacerbation Baseline to Week 52 Proportion of participants who did not experience an exacerbation over 52 weeks.
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score Baseline to Week 52 Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score at Week 52. The SGRQ is a questionnaire that measures health status of participants with airway obstruction diseases. The total score is expressed as a percentage of overall impairment, where 100 represents the worst possible health status and 0 indicates the best possible health status.
The Annualised Asthma Exacerbation Rate Baseline to Week 52 The annualised asthma exacerbation rate is based on exacerbations reported by investigator in eCRF over 52 weeks.
Rate of asthma exacerbation associated with hospitalisation or emergency room (ER) Baseline to Week 52 Rate of asthma exacerbation is based on exacerbations reported by the investigator in eCRF that are associated with a hospitalization or an emergency room visit over 52 weeks.
Categorised percent reduction from baseline in the daily maintenance OCS dose Baseline to Week 52 Categorised percent reduction from baseline in the daily maintenance OCS dose at Week 52. Percent change from baseline is derived as {(final dose-baseline dose)/baseline dose}\*100 and the categories of percent change from baseline are defined as ≥ 90% to ≤ 100% reduction, ≥ 75% to \< 90% reduction, ≥ 50% to \< 75% reduction, \> 0% to \< 50% reduction, no change or any increase.
Proportion of participants who did not experience an exacerbation associated with hospitalisation Baseline to Week 52 Proportion of participants who did not experience an exacerbation associated with hospitalization over 52 weeks.
Change from baseline in Asthma Control Questionnaire 6 (ACQ-6) score Baseline to Week 52 Change from baseline in Asthma Control Questionnaire 6 (ACQ-6) at Week 52. The ACQ-6 captures asthma symptoms and short-acting β2 agonists use via subject-report. Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 score is the mean of the responses.
Absolute and percent change from baseline in daily maintenance OCS dose Baseline to Week 52 Absolute and percent change from baseline in daily maintenance OCS dose at Week 52. Absolute change from baseline is defined as (final dose-baseline dose). Percent change from baseline is defined as {(final OCS dose-baseline OCS)/baseline OCS}\*100.
Change from baseline in post-bronchodilator (post-BD) FEV1 Baseline to Week 52 Change from baseline in post-bronchodilator (post-BD) FEV1 at Week 52. FEV1 is defined as as the volume of air exhaled from the lungs in the first second of a forced expiration.
Change from baseline in standardised Asthma Quality of Life Questionnaire for 12 years and older (AQLQ[s]+12) total score Baseline to Week 52 Change from baseline in standardised Asthma Quality of Life Questionnaire for 12 years and older (AQLQ\[s\]+12) total score at Week 52. The AQLQ\[s\]+12 is a questionnaire that measured the health-related quality of life experienced by asthma subjects. The total score is defined as the average of all 32 questions in the AQLQ\[s\]+12 questionnaire. AQLQ\[s\]+12 is 7 point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). The total score is the mean of the responses.
Trial Locations
- Locations (1)
Research Site
🇬🇧Portsmouth, United Kingdom