Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab
ConditionSevere Asthma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-80
SponsorAstraZeneca
About this trial
This study aims to explore the potential for Tezepelumab-treated severe asthmatic patients to effectively and safely reduce their background maintenance medication while maintaining asthma symptom control.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Documented post-bronchodilator (post-BD) reversibility in FEV1 of ≥12% and ≥200 mL in FEV1, or FEV1≥400 mL variability over time, or positive result of branchial provocation test within 12 months prior to Visit 1. If historical documentation is not available, reversibility must be demonstrated and documented at Visit 1.
Other acceptable asthma controller includes LTRA, LAMA or theophylline 5. On stable MD/HD ICS (>250μg fluticasone propionate dry powder formulation equivalents total daily dose) + LABA stable for ≥2 months prior to enrollment 6. On stable LTRA or LAMA or theophylline (≥2 weeks) is allowed 7. Documented ACQ-5 ≥ 1.5 in Visit 1 8. Documented at least one exacerbation in the year prior to enrolment
A qualifying historical asthma exacerbation is a symptomatic worsening requiring systemic corticosteroid (i.e., oral, intravenous (IV) or intramuscular; any healthcare setting or temporary increase from a stable maintenance dose of oral corticosteroid) or that resulted in hospitalization or emergency room/urgent care visit.
Source documentation is required for physician-diagnosed asthma, ICS-LABA use and asthma exacerbations over the prior year. A patient verbal history suggestive of asthma symptoms and/or prior asthma exacerbations, but without supporting documentation, is not sufficient to satisfy these inclusion criteria.
Disqualifiers
Unable to commit to the scheduled visits as required by the protocol, or unable to commit to undergoing protocol guided reductions in asthma therapy, as directed by the Investigator.
Clinically important pulmonary disease other than asthma (e.g., active lung infection, chronic obstructive pulmonary disease [COPD], bronchiectasis, pulmonary fibrosis, cystic fibrosis), or ever been diagnosed with pulmonary or systemic disease, other than asthma, that is associated with elevated peripheral eosinophil counts (e.g., allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).
Current smokers at Visit 1 are not allowed. Former smokers with smoking history ≥ 10 pack-years at Visit 1 are not allowed; Former smokers with a smoking history of <10 pack years must have stopped for at least 6 months to be eligible.
History of alcohol or drug abuse within 12 months prior to Visit 1(Week -1 to Week 0).
Trial design
Design model
Single group
Treatments tested in this trial
Tezepelumab
DrugSevere asthma taking medium-high dose ICS/LABA with up to one additional controller will be enrolled into this single arm treatment
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: TezepelumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To assess the potential for Tezepelumab treated patients to reduce their standard of care asthma controller regimen in the overall patient population while maintaining asthma control
Main Endpoints: Proportion of patients with at least one controller medication category reduction at the end of reduction phase (week 36) while sustaining asthma control * discontinuation of LTRA, or * discontinuation of LAMA, or * discontinuation of theophylline, or * Reduce inhale therapy to MD ICS/LABA, or * Reduce inhale therapy to LD ICS/LABA
Time frame
within 36 weeks after the first administration2
To assess the potential for Tezepelumab treated patients to reduce their standard of care asthma controller regimen in the overall patient population while maintaining asthma control
Supportive outcomes: * Proportion of patients with individual category reduction at end of reduction phase * Proportion of patients with ≥2 category reductions in controller medication
Time frame
within 36 weeks after the first administrationSecondary outcomes
1
To assess standard asthma efficacy measures for Tezepelumab treated patients for pulmonary function measured by pre-BD FEV1
Change in pre-BD FEV1 measured in litres from: * Week 0 to week 1 * week 0 to week 12 (beginning of induction phase to begining of reduction phase ) * week 12 to week 36 (beginning of reduction phase to beginning of maintenance phase) * week 36 to week 48 (beginning of maintenance phase to the end of maintenance phase)
Time frame
From week0~week482
To assess standard asthma efficacy measures for Tezepelumab treated patients for asthma symptoms control measured by Asthma Control Questionnaire-5(ACQ-5) score
Change in measured by Asthma Control Questionnaire-5(ACQ-5) score from: * Week 0 to week 1 * week 0 to week 12 (beginning of induction phase to begining of reduction phase ) * week 12 to week 36 (beginning of reduction phase to beginning of maintenance phase) * week 36 to week 48 (beginning of maintenance phase to the end of maintenance phase) \[ACQ-5: score 0-6, 6 means worse outcome\]
Time frame
From week0~week483
To assess standard asthma efficacy measures for Tezepelumab treated patients for asthma symptoms control measured by St. George's Respiratory Questionnaire (SGRQ) score
Change in measured by St. George's Respiratory Questionnaire (SGRQ) score from: * Week 0 to week 1 * week 0 to week 12 (beginning of induction phase to begining of reduction phase ) * week 12 to week 36 (beginning of reduction phase to beginning of maintenance phase) * week 36 to week 48 (beginning of maintenance phase to the end of maintenance phase) \[SGRQ: score 0-100, 100 means worse outcome\]
Time frame
From week0~week484
To assess standard asthma efficacy measures for Tezepelumab treated patients for asthma symptoms control measured by Cough Evaluation Test (CET) score
Change in measured by Cough Evaluation Test (CET) score from: * Week 0 to week 1 * week 0 to week 12 (beginning of induction phase to begining of reduction phase ) * week 12 to week 36 (beginning of reduction phase to beginning of maintenance phase) * week 36 to week 48 (beginning of maintenance phase to the end of maintenance phase) \[CET: score 5-25, 25 means worse outcome\]
Time frame
From week0~week48Sponsors and contacts
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Source ClinicalTrials.gov