Effectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Severe Ast… (NCT05329194) | Clinical Trial Compass
CompletedPhase 4
Effectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Severe Asthma in the United States
United States287 participantsStarted 2022-04-29
Plain-language summary
To asses effectiveness and safety of tezepelumab in adult and adolescent participants with severe asthma including several under-studied populations in the United States.
Who can participate
Age range12 Years – 130 Years
SexALL
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Inclusion Criteria:
* Male or female participant must be 12 years of age or older, at the time of signing the informed consent form or assent.
* Documented physician-diagnosed asthma for at least 12 months prior to enrollment and confirmed by the Investigator not to be due to alternative diagnoses.
* 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.
* 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 β-agonist (LABA)).
* Documented history of at least 2 asthma exacerbations during the 12 months prior to enrollment.
* Physician decision that participant is eligible for treatment with tezepelumab according to the approved United States product insert (USPI).
* Currently receiving care from specialist physicians (eg, pulmonologists and/or allergists).
* Provision of signed and dated written informed consent form.
Exclusion Criteria:
* Any contraindication to tezepelumab as per the US approved product label or in the opinion of the Investigator.
* Comorbid diagnosis of severe or very severe chronic obstructive pulmonary disease (COPD) per GOLD guidelines (GOLD 2021).
* Use of biologics that are approved for the treatment of asthma within 4 months or 5 half- lives (whichever is longer…
What they're measuring
1
Annualized asthma exacerbation rate (AAER)
Timeframe: Baseline period up to study Week 52
2
Proportion of participants with asthma exacerbations
Timeframe: Baseline period up to study Week 52
3
Proportion of participants who completed the 52 -week study period with any reduction in total number of asthma exacerbations