Open-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma.

PHASE3RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

September 30, 2024

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2027

Conditions
Severe Asthma
Interventions
COMBINATION_PRODUCT

Tezepelumab

IMP. Subcutaneous injection. Unit dose strengths 210 mg.

COMBINATION_PRODUCT

Budesonide/formoterol

AxMP. Oral inhalation. High-dose: 160 μg/4.5 μg per inhalation; Medium and Low-dose: 80 μg/4.5 μg per inhalation

COMBINATION_PRODUCT

Albuterol/budesonide (AIRSUPRA®)

AxMP. Oral inhalation. Reliever only. Unit dose strengths 90 μg/80 μg per inhalation In US only.

COMBINATION_PRODUCT

Mannitol

NIMP. Oral nebulization. Unit dose strengths: Graduated doses of 0 mg, 5 mg, 10 mg, 20 mg and 40 mg capsules

COMBINATION_PRODUCT

Salbutamol

AxMP. Used outside the US only. Oral inhalation. Unit dose strengths: 100 μg per inhalation

Trial Locations (85)

1070

RECRUITING

Research Site, Anderlecht

1104

RECRUITING

Research Site, Berazategui

1154

RECRUITING

Research Site, Sofia

1431

RECRUITING

Research Site, Sofia

2000

RECRUITING

Research Site, Rosario

2002

RECRUITING

Research Site, Rosario

2650

RECRUITING

Research Site, Edegem

RECRUITING

Research Site, Hvidovre

3000

NOT_YET_RECRUITING

Research Site, Santa Fe

3260

RECRUITING

Research Site, Concepción del Uruguay

3320

WITHDRAWN

Research Site, Kozloduy

4000

RECRUITING

Research Site, San Miguel de Tucumán

RECRUITING

Research Site, Liège

5101

RECRUITING

Research Site, Erpent

5250

RECRUITING

Research Site, Velika Tarnovo

5500

RECRUITING

Research Site, Mendoza

5700

RECRUITING

Research Site, Svendborg

5804

RECRUITING

Research Site, Pleven

6000

WITHDRAWN

Research Site, Stara Zagora

6003

RECRUITING

Research Site, Stara Zagora

6300

RECRUITING

Research Site, Haskovo

7002

RECRUITING

Research Site, Rousse

7100

RECRUITING

Research Site, Vejle

7200

RECRUITING

Research Site, Razgrad

9000

RECRUITING

Research Site, Ghent

RECRUITING

Research Site, Aalborg

10043

RECRUITING

Research Site, Orbassano

13915

RECRUITING

Research Site, Marseille

20354

RECRUITING

Research Site, Hamburg

20782

RECRUITING

Research Site, Hyattsville

27002

RECRUITING

Research Site, Lugo

28006

RECRUITING

Research Site, Madrid

28040

RECRUITING

Research Site, Madrid

28041

RECRUITING

Research Site, Madrid

30625

RECRUITING

Research Site, Hanover

31008

RECRUITING

Research Site, Pamplona

31200

NOT_YET_RECRUITING

Research Site, Chihuahua City

33011

NOT_YET_RECRUITING

Research Site, Oviedo

33076

RECRUITING

Research Site, Bordeaux

33136

RECRUITING

Research Site, Miami

34295

RECRUITING

Research Site, Montpellier

37134

RECRUITING

Research Site, Verona

38700

RECRUITING

Research Site, La Tronche

44670

NOT_YET_RECRUITING

Research Site, Guadalajara

50134

RECRUITING

Research Site, Florence

53127

RECRUITING

Research Site, Bonn

55128

RECRUITING

Research Site, Mainz

63110

RECRUITING

Research Site, St Louis

64060

NOT_YET_RECRUITING

Research Site, Monterrey

64360

NOT_YET_RECRUITING

Research Site, Monterrey

67091

RECRUITING

Research Site, Strasbourg

69004

RECRUITING

Research Site, Lyon

73120

RECRUITING

Research Site, Oklahoma City

78503

RECRUITING

Research Site, McAllen

80907

RECRUITING

Research Site, Colorado Springs

81377

NOT_YET_RECRUITING

Research Site, München

84131

RECRUITING

Research Site, Salerno

86150

RECRUITING

Research Site, Augsburg

91910

NOT_YET_RECRUITING

Research Site, Veracruz

93551

RECRUITING

Research Site, Palmdale

94000

RECRUITING

Research Site, Créteil

95123

RECRUITING

Research Site, Catania

02115

RECRUITING

Research Site, Boston

08901

RECRUITING

Research Site, New Brunswick

C1012AAR

RECRUITING

Research Site, CABA

M5500CCG

RECRUITING

Research Site, Mendoza

B1878FNR

RECRUITING

Research Site, Quilmes

T6G 2B7

WITHDRAWN

Research Site, Edmonton

V5Z 1M9

RECRUITING

Research Site, Vancouver

L1S 2J5

RECRUITING

Research Site, Ajax

N8X 1T3

RECRUITING

Research Site, Windsor

G1V 4G5

RECRUITING

Research Site, Québec

J1H 5N4

RECRUITING

Research Site, Sherbrooke

S7N 5A2

RECRUITING

Research Site, Regina

03050

RECRUITING

Research Site, Cottbus

09122

RECRUITING

Research Site, Cagliari

00161

RECRUITING

Research Site, Roma

00168

RECRUITING

Research Site, Roma

06700

NOT_YET_RECRUITING

Research Site, Cuauhtémoc

08916

RECRUITING

Research Site, Badalona(Barcelona)

08035

RECRUITING

Research Site, Barcelona

BT9 7BL

RECRUITING

Research Site, Belfast

L7 8XP

RECRUITING

Research Site, Liverpool

SE1 9RT

RECRUITING

Research Site, London

SO16 6YD

RECRUITING

Research Site, Southampton

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Fortrea

INDUSTRY

lead

AstraZeneca

INDUSTRY