Severe Asthma
Conditions
Interventions
Trade Name: Tezspire-APFS
Product Name: Tezepelumab
Product Code: MEDI9929
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Tezepelumab
CAS Number: 1572943-04-4
Current Sponsor code: M
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1, Male or female participant must be 12 years of age or older, at the time of signing the informed consent form or assent. 2, Documented physician-diagnosed asthma for at least 12 months prior to enrollment and confirmed by the Investigator not to be due to alternative diagnoses. 3, Documented treatment with medium- to high dose ICS as per Global Initiative for Asthma (GINA) guidelines (GINA 2021) for at least 12 months prior to enrollment. 4, Use of additional asthma maintenance controller medication(s) in addition to ICS for at least 12 months prior to enrollment. The additional maintenance controller medication may be contained in a combination product (eg, ICS/ long-acting ß-agonist (LABA)). 5, Documented history of at least 2 asthma exacerbations during the 12 months prior to enrollment. 6, Physician decision that participant is eligible for treatment with tezepelumab according to the approved United States product insert (USPI). 7, Currently receiving care from specialist physicians (eg,pulmonologists and/or allergists). 8, Provision of signed and dated written informed consent form Are the trial subjects under 18? yes Number of subjects for this age range: 19 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 77
Exclusion criteria
Exclusion criteria: 1, Any contraindication to tezepelumab as per the US approved product label or in the opinion of the Investigator. 2, Comorbid diagnosis of severe or very severe chronic obstructive pulmonary disease (COPD) per GOLD guidelines (GOLD 2021). 3, Use of biologics that are approved for the treatment of asthma within 4 months or 5 half- lives (whichever is longer) prior to enrollment. 4, Participation in an interventional clinical trial for asthma within 12 months prior to enrollment. 5, Judgment by the Investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe asthma exacerbations in the 12-month periods before (baseline period) and after initiation of tezepelumab (study period);Secondary Objective: - To describe the time to first exacerbation after initiation of tezepelumab - To describe asthma exacerbations resulting in hospitalizations, emergency department/urgent care visits in the 12-month periods before - baseline period (BP) and after initiation of Tezepelumab – study period (SP) - To describe lung function at baseline and months 6 and 12 after initiation of tezepelumab - To describe Asthma Control Questionnaire (ACQ-6), Asthma Impairment and Risk Questionnaire (AIRQ), and St. George’s Respiratory Questionnaire (SGRQ) at baseline and months 6 and 12 after initiation of tezepelumab - To describe systemic corticosteroid (SCS) use in the 12- month periods before (baseline period) and after initiation of tezepelumab (study period) - To describe asthma-related healthcare resource utilization (HRU) in the 12-month periods before (baseline period) and after initiation of tezepelumab (study period) - For other secondary objectives;Primary end point(s): Annualized asthma exacerbation rate (AAER) over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) ;Timepoint(s) of evaluation of this end point: Baseline period up to study Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to first asthma exacerbation - Rate of asthma exacerbations associated with hospitalizations - Rate of asthma exacerbations associated with ED/UC visits - Rate of asthma exacerbations associated with hospitalizations or ED/UC visits - Proportion of participants with asthma exacerbations associated with hospitalizations or ED/UC visits - Cumulative asthma exacerbations associated with hospitalizations or ED/UC visits - Pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) - Change from baseline in pre-bronchodilator FEV1 - Proportion of pre-BD FEV1 responders - Change from baseline in Asthma Control Questionnaire (ACQ-6) score - Change from baseline in Asthma Impairment and Risk Questionnaire (AIRQ) score - Change from baseline in St. George's Respiratory Questionnaire (SGRQ) score - Proportion of ACQ-6 responders - Proportion of AIRQ responders - Proportion of SGRQ responders - Proportion of participants who require any systemic corticosteroid (SCS) use - Cumulative annualized SCS dose - Proportion of participants who require longer-term (>30 consecutive days) SCS use - Number and type of asthma-related healthcare resource utilization (HRU) - Duration of asthma-related hospitalizations - AAER for asthma exacerbations (subgroups of participants) - Proportion of participants with asthma exacerbations (subgroups of participants) - Proportion of participants who completed the 52 week study with any reduction in total number of asthma exacerbations (subgroups of participants) - Cumulative asthma exacerbation days (subgroups of participants) - Rate of asthma exacerbations associated with hospitalizations (subgroups of participants) - Rate of asthma exacerbations associated with emergency department urgent care (ED/UC) visits (subgroups of participants) - Rate of asthma exacerbations associated with hospitalizations or ED/UC visits over (subgroups of participants) - Number and type of asthma-related HRU (subgroups of partici | — |
Countries
United States
Contacts
Public ContactClinical Study Information Center
AstraZeneca
Outcome results
None listed