Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma

Phase 3

Completed

• Conditions: Asthma

• Registration Number: NCT03927157
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-4-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 405

Inclusion Criteria

Inclusion Criteria:<br><br> - Age. 18-80<br><br> - Documented physician-diagnosed asthma for at least 12 months<br><br> - Participants who have received a physician-prescribed asthma controller medication<br> with medium or high dose ICS for at least 6 months.<br><br> - Documented treatment with a total daily dose of either medium or high dose ICS (=<br> 500 µg fluticasone propionate dry powder formulation equivalent total daily dose)<br> for at least 3 months.<br><br> - At least one additional maintenance asthma controller medication is required<br> according to standard practice of care and must be documented for at least 3 months.<br><br> - Morning pre-BD FEV1 <80% predicted normal<br><br> - Evidence of asthma as documented by either: Documented historical reversibility of<br> FEV1 =12% and =200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol)<br> reversibility of FEV1 =12% and =200 mL during screening.<br><br> - Documented history of at least 2 asthma exacerbation events within 12 months, and at<br> least one of the exacerbations should occur during the treatment of medium-to-high<br> dose ICS.<br><br> - ACQ-6 score =1.5 at screening and on day of randomization<br><br>Exclusion Criteria:<br><br> - Pulmonary disease other than asthma.<br><br> - History of cancer.<br><br> - History of a clinically significant infection.<br><br> - Current smokers or participants with smoking history =10 pack-yrs.<br><br> - History of chronic alcohol or drug abuse within 12 months.<br><br> - Hepatitis B, C or HIV.<br><br> - Pregnant or breastfeeding.<br><br> - History of anaphylaxis following any biologic therapy.<br><br> - participant randomized in the current study or previous tezepelumab studies.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Annualized asthma exacerbation rate (AERR)