Phase
Condition
Asthma
Treatment
Albuterol/budesonide (AIRSUPRA®)
Mannitol
Salbutamol
Clinical Study ID
Ages 12-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria at Visit 1 (Screening):
Informed Consent
Provision of signed and dated written ICF prior to any mandatory study-specificprocedures, sampling, and analyses for patients who are at or over the age ofmajority (as per local law). For patients who are less than the age of majority, inaddition to providing their informed consent, the patients' legally authorisedrepresentative must also provide their informed assent (Appendix A 3). Age
Patients must be 12 to 80 years of age inclusive, at the time of signing the ICF. Type of Patient and Disease Characteristics
Documented medical record history for at least 12 months prior to Visit 1.
Documented physician-diagnosed severe asthma within 10 years prior to Visit 1 (ie,severe asthma was not diagnosed more than 10 years prior) consisting of any of thefollowing:
FEV1 > 12% reversibility, OR
Evidence of airflow variability (to show that lung function is altered overtime): FEV1 ≥ 400 mL variability over time, OR
Challenge tests that are positive on one of the below:
(i) Methacholine - PD20 ≤ 8 mg/mL (ii) Mannitol - PD15 15% drop on FEV1 out of dose < than 635 mg of inhaled mannitol (iii) Exercise - 10% fall of FEV1
ACQ-5 ≥ 1.5 and < 3.
History of physician-diagnosed asthma that requires continuous treatment withhigh-dose ICS (as defined by GINA or highest approved dose per posology per country)plus a LABA for at least 6 months prior to Visit 1 (Appendix I). The ICS and LABAcan be contained within a combination product or given by separate inhalers. Note: Additional maintenance asthma controller medications (eg, LTRAs, tiotropium,cromone, theophylline) are allowed.
Pre-brochodilator FEV1 > 60% predicted and evidence of FEV1 reversibility of > 12%within 6 months prior to screening or at screening. Patients with normal lungfunction (FEV1 > 80%) need evidence of airflow variability as per inclusioncriterion 4.
Documented history of at least one asthma exacerbation requiring OCS bursts orrequiring hospitalization within 12 months prior to Visit 1. An asthma exacerbationwill be defined as a worsening of asthma symptoms that leads to any of thefollowing:
A temporary bolus/burst of systemic corticosteroids for at least 3 consecutivedays to treat symptoms of asthma worsening; a single depo-injectable dose ofcorticosteroids will be considered equivalent to a 3-day bolus/burst ofsystemic corticosteroids
Or, an ER visit (defined as evaluation and treatment for < 24 hours in ER) dueto asthma that required systemic corticosteroids (as per above)
Or, an in-patient hospitalisation (defined as admission to an inpatientfacility and/or evaluation and treatment in a healthcare facility for ≥ 24hours). Sex and Contraceptive/Barrier Requirements
Male or female. Female patients:
Contraceptive use by women should be consistent with local regulationsregarding the methods of contraception for those participating in clinicalstudies. Women of nonchildbearing potential are defined as women who are eitherpermanently sterilised (hysterectomy, bilateral oophorectomy, or bilateralsalpingectomy) or who are postmenopausal. Women will be consideredpostmenopausal if they have been amenorrhoeic for 12 months prior to theplanned start date of the induction phase without an alternative medical cause.
The following age-specific requirements apply:
Women < 50 years old would be considered postmenopausal if they have beenamenorrhoeic for 12 months or more following cessation of exogenoushormonal treatment and follicle-stimulating hormone levels in thepostmenopausal range.
Women ≥ 50 years old would be considered postmenopausal if they have beenamenorrhoeic for 12 months or more following cessation of all exogenoushormonal treatment.
Adolescents: if patient is female and has reached menarche or has reachedTanner stage 3 breast development (even if not having reached menarche),the patient will be considered a WOCBP.
- WOCBP must be willing to use one of the methods of contraception describedhereafter, from the time of signing the ICF throughout the study and 16 weeks afterlast tezepelumab administration:
Combined (oestrogen and progestogen containing) hormonal contraceptionassociated with inhibition of ovulation: oral, intravaginal, transdermal
Progestogen-only hormonal contraception associated with inhibition ofovulation: oral, injectable, implantable
Intrauterine device
Intrauterine hormone-releasing system
Bilateral tubal occlusion
Vasectomised partner (vasectomised partner is a highly effective birth controlmethod provided that the partner is the sole sexual partner of the WOCBPpatient and that the vasectomised partner has received medical assessment ofthe surgical success)
Sexual abstinence: it is considered a highly effective method only if definedas refraining from heterosexual intercourse during the entire period of riskassociated with the study treatments. The reliability of sexual abstinenceneeds to be evaluated in relation to the duration of the study and thepreferred and usual lifestyle of the patient.
Cessation of contraception after this point should be discussed with aresponsible physician Inclusion Criteria 5.1.2 Treatment Induction Phase at Visit 2 (Week 0): Before dosing with tezepelumab at Week 0, patients should fulfil the followingcriteria:
ACQ-5 ≥ 1.5 and < 3.
Demonstrated proper inhaler technique (patients with improper technique at screeningmay be trained during screening, but must demonstrate proper technique beforeenrollment).
No excessive SABA use (should be < 5 puffs/day) or for patients using SMART therapyoutside the US, no excessive use of SYMBICORT (should be ≤ 8 inhalations/day) or forUS patients, no excessive use of AIRSUPRA (should be ≤ 12 inhalations/day).
Exclusion
Exclusion Criteria:
Medical Conditions
Any clinically important pulmonary disease other than asthma (eg, active lunginfection, chronic obstructive pulmonary disease, bronchiectasis, pulmonaryfibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lungcancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) orpulmonary or systemic diseases, other than asthma, that are associated with elevatedperipheral EOS counts (eg, allergic bronchopulmonary aspergillosis/mycosis,Churg-Strauss syndrome, hypereosinophilic syndrome).
Any disorder, including, but not limited to, cardiovascular, gastrointestinal,hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic,haematological, psychiatric, or major physical impairment that is not stable in theopinion of the investigator and could:
Affect the safety of the patient throughout the study
Influence the findings of the study or the interpretation
Impede the patient's ability to complete the entire duration of study.
A helminth parasitic infection diagnosed within 6 months prior to Visit 1 that hasnot been treated with, or has failed to respond to, standard of care therapy.
Current smokers or patients with smoking history ≥ 10 pack-years and patients usingvaping products, including electronic cigarettes. Former smokers with a smokinghistory of < 10 pack-years and users of vaping or e-cigarette products must havestopped for at least 6 months prior to Visit 1 to be eligible.
History of chronic alcohol or drug abuse within 12 months prior to Visit 1.
Tuberculosis requiring treatment within the 12 months prior to Visit 1.
History of known immunodeficiency disorder including a positive humanimmunodeficiency virus test at Visit 1, or the patient taking antiretroviralmedications as determined by medical history and/or patient's verbal report.
Major surgery within 8 weeks prior to Visit 1 or planned surgical proceduresrequiring general anaesthesia or inpatient status for > 1 day during the conduct ofthe study.
Evidence of COVID-19 within 4 weeks prior to screening or ongoing clinicallysignificant COVID-19 sequelae. Prior/Concomitant Therapy
Receipt of any marketed or investigational biologic agent within 4 months or 5half-lives (whichever is longer) prior to Visit 1 or receipt of any investigationalnonbiologic agent within 30 days or 5 half-lives (whichever is longest) prior toVisit 1.
OCS-dependent patients (received chronic OCS therapy [prednisone ≥ 5 mg/day orequivalent]) for at least 3 months preceding Visit 1.
Daily use of maintenance corticosteroids for any reason.
Treatment with systemic immunosuppressive/immunomodulating drugs (eg, methotrexate,cyclosporine, etc.), except for OCS used in the treatment of asthma/asthmaexacerbations, within the last 12 weeks or 5 half-lives (whichever is longer) priorto Visit 1.
Receipt of immunoglobulin or blood products within 30 days prior to Visit 1.
Receipt of live attenuated vaccines 30 days prior to the date of Visit 1 and duringthe study.
Patients that have been treated with bronchial thermoplasty in the last 12 monthsprior to Visit 1. Prior/Concurrent Clinical Study Experience
Known history of sensitivity to any component of the tezepelumab formulation or ahistory of drug or other allergy that, in the opinion of the investigator or medicalmonitor, contraindicates their participation.
History of anaphylaxis or documented immune complex disease (Type IIIhypersensitivity reactions) following any biologic therapy.
Concurrent enrolment in another clinical study involving an IMP. Diagnostic Assessments
Any clinically meaningful abnormal finding in physical examination, haematology,clinical chemistry at Visit 1 which, in the opinion of the investigator, may put thepatient at risk because of his/her participation in the study, or may influence theresults of the study, or the patient's ability to complete the entire duration ofthe study.
Evidence of active liver disease, including jaundice or AST, ALT, or ALP > 2 timesthe ULN at Visit 1.
Positive hepatitis B surface antigen, hepatitis C virus antibody serology atscreening, or a positive medical history for hepatitis B or C. Patients with ahistory of hepatitis B vaccination without a history of hepatitis B are allowed toparticipate. Other Exclusions
Involvement in the planning and/or conduct of the study (applies to AstraZenecastaff and/or site staff), or patients employed by or relatives of the employees ofthe site or AstraZeneca.
Judgement by the investigator that the patient should not participate in the studyif the patient is unlikely to comply with study procedures, restrictions, andrequirements.
For women only: Pregnant, breastfeeding, or lactating women. A serum β-HCG pregnancytest must be drawn for WOCBP at the screening visit. If the results of the serum β-HCG cannot be obtained prior to dosing of the IMP, a patient may be enrolled onthe basis of a negative urine pregnancy test, though serum β-HCG must still beobtained. If either test is positive, the patient should be excluded. Since urineand serum tests may miss a pregnancy in the first days after conception, relevantmenstrual history and sexual history, including methods of contraception, should beconsidered. Any patient whose menstrual and/or sexual history suggests thepossibility of early pregnancy should be excluded.
Study Design
Study Description
Connect with a study center
Research Site
Berazategui, 1104
ArgentinaSite Not Available
Research Site
Caba, C1012AAR
ArgentinaActive - Recruiting
Research Site
Concepción del Uruguay, 3260
ArgentinaActive - Recruiting
Research Site
Mendoza, M5500CCG
ArgentinaSite Not Available
Research Site
Quilmes, B1878FNR
ArgentinaSite Not Available
Research Site
Rosario, 2002
ArgentinaSite Not Available
Research Site
San Miguel de Tucuman, 4000
ArgentinaActive - Recruiting
Research Site
Santa Fe, 3000
ArgentinaSite Not Available
Research Site
Anderlecht, 1070
BelgiumActive - Recruiting
Research Site
Edegem, 2650
BelgiumActive - Recruiting
Research Site
Erpent, 5101
BelgiumActive - Recruiting
Research Site
Gent, 9000
BelgiumActive - Recruiting
Research Site
Liège, 4000
BelgiumActive - Recruiting
Research Site
Haskovo, 6300
BulgariaActive - Recruiting
Research Site
Kozloduy, 3320
BulgariaSite Not Available
Research Site
Pleven, 5804
BulgariaActive - Recruiting
Research Site
Razgrad, 7200
BulgariaActive - Recruiting
Research Site
Ruse, 7002
BulgariaActive - Recruiting
Research Site
Sofia, 1154
BulgariaActive - Recruiting
Research Site
Stara Zagora, 6000
BulgariaSite Not Available
Research Site
Velika Tarnovo, 5250
BulgariaActive - Recruiting
Research Site
Edmonton, Alberta T6G 2B7
CanadaSite Not Available
Research Site
Vancouver, British Columbia V5Z 1M9
CanadaActive - Recruiting
Research Site
Ajax, Ontario L1S 2J5
CanadaActive - Recruiting
Research Site
Windsor, Ontario N8X 1T3
CanadaActive - Recruiting
Research Site
Sherbrooke, Quebec J1H 5N4
CanadaActive - Recruiting
Research Site
Regina, Saskatchewan S7N 5A2
CanadaActive - Recruiting
Research Site
Quebec, G1V 4G5
CanadaActive - Recruiting
Research Site
Aalborg, 9000
DenmarkActive - Recruiting
Research Site
Hvidovre, 2650
DenmarkActive - Recruiting
Research Site
Svendborg, 5700
DenmarkActive - Recruiting
Research Site
Vejle, 7100
DenmarkActive - Recruiting
Research Site
Bordeaux, 33076
FranceActive - Recruiting
Research Site
Créteil, 94000
FranceActive - Recruiting
Research Site
La Tronche, 38700
FranceActive - Recruiting
Research Site
Lyon, 69004
FranceActive - Recruiting
Research Site
Marseille, 13915
FranceActive - Recruiting
Research Site
Montpellier, 34295
FranceActive - Recruiting
Research Site
Strasbourg, 67091
FranceActive - Recruiting
Research Site
Augsburg, 86150
GermanyActive - Recruiting
Research Site
Bonn, 53127
GermanySite Not Available
Research Site
Cottbus, 03050
GermanyActive - Recruiting
Research Site
Hamburg, 20354
GermanyActive - Recruiting
Research Site
Hannover, 30625
GermanyActive - Recruiting
Research Site
Mainz, 55128
GermanyActive - Recruiting
Research Site
München, 81377
GermanySite Not Available
Research Site
Cagliari, 09122
ItalyActive - Recruiting
Research Site
Catania, 95123
ItalyActive - Recruiting
Research Site
Firenze, 50134
ItalyActive - Recruiting
Research Site
Orbassano, 10043
ItalyActive - Recruiting
Research Site
Roma, 00168
ItalyActive - Recruiting
Research Site
Salerno, 84131
ItalyActive - Recruiting
Research Site
Verona, 37134
ItalyActive - Recruiting
Research Site
Chihuahua, 31200
MexicoSite Not Available
Research Site
Cuauhtémoc, 06700
MexicoSite Not Available
Research Site
Guadalajara, 44670
MexicoSite Not Available
Research Site
Monterrey, 64060
MexicoSite Not Available
Research Site
Veracruz, 91910
MexicoSite Not Available
Research Site
Badalona(Barcelona), 08916
SpainActive - Recruiting
Research Site
Barcelona, 08035
SpainActive - Recruiting
Research Site
Lugo, 27002
SpainActive - Recruiting
Research Site
Madrid, 28041
SpainActive - Recruiting
Research Site
Pamplona, 31008
SpainActive - Recruiting
Research Site
Rosario, 2002
SpainActive - Recruiting
Research Site
Belfast, BT9 7BL
United KingdomSite Not Available
Research Site
Liverpool, L7 8XP
United KingdomActive - Recruiting
Research Site
London, SE1 9RT
United KingdomSite Not Available
Research Site
Southampton, SO16 6YD
United KingdomActive - Recruiting
Research Site
Palmdale, California 93551
United StatesActive - Recruiting
Research Site
Colorado Springs, Colorado 80907
United StatesActive - Recruiting
Research Site
Miami, Florida 33136
United StatesActive - Recruiting
Research Site
Hyattsville, Maryland 20782
United StatesActive - Recruiting
Research Site
Boston, Massachusetts 02115
United StatesActive - Recruiting
Research Site
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Research Site
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
Research Site
Oklahoma City, Oklahoma 73120
United StatesActive - Recruiting
Research Site
McAllen, Texas 78503
United StatesActive - Recruiting
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