Study identifier:D5180C00047
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Multicentre, Randomised, Open-Label, Parallel-Group, Phase IIIb Study to Assess the Potential for Tezepelumab-treated Patients with Severe Asthma to Reduce Background Therapy While Sustaining Asthma Control and Clinical Remission
Severe Asthma
Phase 3
No
Tezepelumab, Budesonide/formoterol, Albuterol/budesonide (AIRSUPRA®), Mannitol, Salbutamol
All
300
Interventional
12 Years - 80 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jun 2024 by AstraZeneca
AstraZeneca
Fortrea
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Group 1 - Asthma Control or Low Biomarkers - Step-down of ICS Asthma Control or Low Biomarkers - Step-down of ICS. Only patients with asthma control or low biomarkers at Week 24 will be randomized into Group 1 or 2 | Combination Product: Tezepelumab IMP. Subcutaneous injection. Unit dose strengths 210 mg. Other Name: TEZSPIRE® Combination Product: Budesonide/formoterol AxMP. Oral inhalation. High-dose: 160 μg/4.5 μg per inhalation; Medium and Low-dose: 80 μg/4.5 μg per inhalation Other Name: SYMBICORT® pMDI Combination Product: Albuterol/budesonide (AIRSUPRA®) AxMP. Oral inhalation. Reliever only. Unit dose strengths 90 μg/80 μg per inhalation In US only. Other Name: AIRSUPRA® Combination Product: Mannitol NIMP. Oral nebulization. Unit dose strengths: Graduated doses of 0 mg, 5 mg, 10 mg, 20 mg and 40 mg capsules Other Name: ARIDOL® Combination Product: Salbutamol AxMP. Used outside the US only. Oral inhalation. Unit dose strengths: 100 μg per inhalation Other Name: Sabumalin, albuterol, ventolin HFA, Proair HFA, Proventil HFA |
Experimental: Group 2 - Asthma Control or Low Biomarkers - No Step-down of ICS Asthma Control or Low Biomarkers - No Step-down of ICS. Only patients with asthma control or low biomarkers at Week 24 will be randomized into Group 1 or 2 | Combination Product: Tezepelumab IMP. Subcutaneous injection. Unit dose strengths 210 mg. Other Name: TEZSPIRE® Combination Product: Budesonide/formoterol AxMP. Oral inhalation. High-dose: 160 μg/4.5 μg per inhalation; Medium and Low-dose: 80 μg/4.5 μg per inhalation Other Name: SYMBICORT® pMDI Combination Product: Albuterol/budesonide (AIRSUPRA®) AxMP. Oral inhalation. Reliever only. Unit dose strengths 90 μg/80 μg per inhalation In US only. Other Name: AIRSUPRA® Combination Product: Mannitol NIMP. Oral nebulization. Unit dose strengths: Graduated doses of 0 mg, 5 mg, 10 mg, 20 mg and 40 mg capsules Other Name: ARIDOL® Combination Product: Salbutamol AxMP. Used outside the US only. Oral inhalation. Unit dose strengths: 100 μg per inhalation Other Name: Sabumalin, albuterol, ventolin HFA, Proair HFA, Proventil HFA |
Experimental: Group 3 - No Asthma Control or Low Biomarkers - No Step-down of ICS No Asthma Control or Low Biomarkers - No Step-down of ICS | Combination Product: Tezepelumab IMP. Subcutaneous injection. Unit dose strengths 210 mg. Other Name: TEZSPIRE® Combination Product: Budesonide/formoterol AxMP. Oral inhalation. High-dose: 160 μg/4.5 μg per inhalation; Medium and Low-dose: 80 μg/4.5 μg per inhalation Other Name: SYMBICORT® pMDI Combination Product: Albuterol/budesonide (AIRSUPRA®) AxMP. Oral inhalation. Reliever only. Unit dose strengths 90 μg/80 μg per inhalation In US only. Other Name: AIRSUPRA® Combination Product: Mannitol NIMP. Oral nebulization. Unit dose strengths: Graduated doses of 0 mg, 5 mg, 10 mg, 20 mg and 40 mg capsules Other Name: ARIDOL® |