Study to Evaluate Tezepelumab on Airway Inflammation in Adults With Uncontrolled Asthma (CASCADE)
NCT ID: NCT03688074
Last Updated: 2022-02-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
116 participants
INTERVENTIONAL
2018-11-02
2020-11-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Tezepelumab
Tezepelumab subcutaneous injection
Tezepelumab
Tezepelumab subcutaneous injection
Placebo
Placebo subcutaneous injection
Placebo
Placebo subcutaneous injection
Interventions
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Tezepelumab
Tezepelumab subcutaneous injection
Placebo
Placebo subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* Documented physician-diagnosed asthma for at least 12 months.
* Subjects who have received a physician- prescribed asthma controller medication with medium or high dose ICS for at least 12 months; must be stable for at least 3 months prior to screening visit.
* At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
* At enrolment, the subject must have a predicted normal value for the morning pre-bronchodilator FEV1\>50% and more than 1L.
* Evidence of asthma as documented by reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months prior to screening, or during the screening period prior to randomization.
* ACQ-6 score ≥ 1.5 during the screening period prior to randomization.
Exclusion Criteria
* History of cancer.
* Hospitalization or required OCS for asthma exacerbation within 6 weeks of enrolment or \>3 exacerbations requiring OCS or hospitalization in the year prior to visit 1 or who had been intubated or admitted to ICU for asthma exacerbation in the year prior to enrolment.
* History of a clinically significant infection, including upper (URTI) or lower respiratory tract infection (LRTI), requiring treatment with antibiotics or antiviral medications finalized \<2 weeks before visit 1 or during the run-in period.
* Current smokers or subjects with smoking history ≥10 pack-yrs, including e-cigarettes. Former smokers with a smoking history of \<10 pack-yrs must have stopped for at least 6 months prior to visit 1, including e-cigarette use.
* History of chronic alcohol or drug abuse within 12 months prior to visit 1.
* Tuberculosis requiring treatment within 12 months prior to visit 1.
* History of known immunodeficiency disorder including a positive HIV test at visit 1, or the subject is taking antiretroviral medications as determined by medical history and/or subject's verbal report.
* History of anaphylaxis or documented immune complex disease (type III hypersensitivity reactions) following any biologic therapy Subject randomized in a previous Tezepelumab study or in a current study with another investigational product.
* Pregnant, breastfeeding or lactating women.
18 Years
75 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Chris Brightling
Role: PRINCIPAL_INVESTIGATOR
University of Leicester, United Kingdom
Locations
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Research Site
Denver, Colorado, United States
Research Site
New Haven, Connecticut, United States
Research Site
Boston, Massachusetts, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Galveston, Texas, United States
Research Site
Calgary, Alberta, Canada
Research Site
Vancouver, British Columbia, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Aalborg, , Denmark
Research Site
Aarhus N, , Denmark
Research Site
Hvidovre, , Denmark
Research Site
København NV, , Denmark
Research Site
Næstved, , Denmark
Research Site
Odense C, , Denmark
Research Site
Vejle, , Denmark
Research Site
Frankfurt, , Germany
Research Site
Frankfurt am Main, , Germany
Research Site
Großhansdorf, , Germany
Research Site
Landsberg, , Germany
Research Site
Cambridge, , United Kingdom
Research Site
Headington, , United Kingdom
Research Site
Leicester, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Nottingham, , United Kingdom
Research Site
Wythenshawe, , United Kingdom
Countries
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References
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Nordenmark LH, Hellqvist A, Emson C, Diver S, Porsbjerg C, Griffiths JM, Newell JD, Peterson S, Pawlikowska B, Parnes JR, Megally A, Colice G, Brightling CE. Tezepelumab and Mucus Plugs in Patients with Moderate-to-Severe Asthma. NEJM Evid. 2023 Oct;2(10):EVIDoa2300135. doi: 10.1056/EVIDoa2300135. Epub 2023 Sep 20.
Pham TH, Chen C, Colice G, Parnes JR, Griffiths JM, Cook B. Tezepelumab normalizes serum interleukin-5 and -13 levels in patients with severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2021 Dec;127(6):689-691. doi: 10.1016/j.anai.2021.08.008. Epub 2021 Aug 14. No abstract available.
Diver S, Khalfaoui L, Emson C, Wenzel SE, Menzies-Gow A, Wechsler ME, Johnston J, Molfino N, Parnes JR, Megally A, Colice G, Brightling CE; CASCADE study investigators. Effect of tezepelumab on airway inflammatory cells, remodelling, and hyperresponsiveness in patients with moderate-to-severe uncontrolled asthma (CASCADE): a double-blind, randomised, placebo-controlled, phase 2 trial. Lancet Respir Med. 2021 Nov;9(11):1299-1312. doi: 10.1016/S2213-2600(21)00226-5. Epub 2021 Jul 10.
Emson C, Diver S, Chachi L, Megally A, Small C, Downie J, Parnes JR, Bowen K, Colice G, Brightling CE. CASCADE: a phase 2, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the effect of tezepelumab on airway inflammation in patients with uncontrolled asthma. Respir Res. 2020 Oct 13;21(1):265. doi: 10.1186/s12931-020-01513-x.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D5180C00013
Identifier Type: -
Identifier Source: org_study_id
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