STRATOS 2

Phase 3

• Conditions: ncontrolled Asthma

• Registration Number: JPRN-jRCT2080222698
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Documented physician-diagnosed asthma.
- Documented treatment with ICS at a total daily dose corresponding to 500 micrograms fluticasone propionate dry powder formulation equivalents) and a LABA
- Morning pre-BD FEV1 value of 40 or more and <80% value (<90% for patients 12 to 17 years of age) of their PNV.
- Post-BD reversibility of 12% or more and 200 mL or more in FEV1
- ACQ-6 score 1.5 or more

Exclusion Criteria

- Pulmonary disease other than asthma
- History of anaphylaxis following any biologic therapy
- Hepatitis B, C or HIV
- Pregnant or breastfeeding
- History of cancer
- Current tobacco smoking or a history of tobacco smoking for 10 pack-years or more
- Previous receipt of tralokinumab

Study & Design

• Study Type: Interventional
• Study Design: Not specified