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RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: testing Biologics targeting Type 2 inflammation for Asthma

This prospective, real-world watch-and-measure (no experimental treatment required) study (T2AIR Study) evaluates the long-term how well it works and safety of six biologics targeting Type 2 inflammation - omalizumab, mepolizumab, benralizumab, dupilumab, tezepelumab, and depemokimab - in patients with chronic airway diseases, including asthma and COPD under routine clinical practice in China. The primary objective is to determine the annualized exacerbation rate (AER) over 12 months of treatment.

Official registry: https://clinicaltrials.gov/study/NCT07823842 · Shanghai Pulmonary Hospital, Shanghai, China · enrollment listed as 538

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 538 people at Shanghai. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Real-World Efficacy and Safety of Biologics Targeting Type 2 Inflammation Across the Spectrum of Chronic Airway Diseases - A Prospective Observational Study in Asthma and COPD

Interventions: Biologics targeting Type 2 inflammation, Patients with asthma and copd who received standard of care

Primary outcome (registry wording): Annual rate of protocol-defined exacerbations of chronic airway disease over 12 months

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Subjects must meet all of the following criteria:
  • 1\. Age ≥ 18 years; 2. Confirmed diagnosis of at least one of the following chronic airway diseases:
  • Chronic Obstructive Pulmonary Disease (COPD): Diagnosed according to the 2026 GOLD guidelines, with symptoms of dyspnea, chronic cough, or sputum production, and/or history of exposure to risk factors, and post-bronchodilator FEV₁/FVC \< 70%
  • 3\. Meets clinical indications for biologic therapy as judged by a respiratory or allergy specialist according to current guidelines:
  • Asthma: Poor control despite optimized high-dose ICS-LABA therapy, presence of allergic or eosinophilic inflammatory biomarkers, or severe/refractory disease requiring maintenance oral corticosteroids (OCS)
  • COPD: Frequent exacerbations despite triple inhaled therapy (ICS + LABA + LAMA), with blood eosinophil count (EOS) ≥ 300/μL and chronic bronchitis phenotype

Public study contact (from the registry)

Gao Yong-hua, PhD, MD

+8617321278520

gaoyonghuahust@163.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07823842 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07823842?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07823842?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary