Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1 Age. 18-75
2 Documented physician-diagnosed asthma for at least 12 months before visit 1.
3 Subjects who have received a physician-prescribed asthma controller medication with medium or high dose inhaled glucocorticosteroid (ICS) for at least 12 months before visit 1.
4 Documented treatment with a total daily dose of either medium or high dose ICS for at least 3 months before visit 1.
5 At least one additional maintenance asthma controller medication such as Long acting β2 receptor agonist (LABA), leukotriene receptor antagonist (LTRA), theophylline, Long-acting muscarinic antagonists (LAMA), sodium cromoglycate, etc. is required according to standard practice of care and must be documented for at least 3 months.
6 Morning pre-BD FEV1 \<80% predicted normal At visit 2 or visit 2a.
7 Evidence of asthma as documented by either: Documented historical reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months before visit 1 OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening At visit 2 or visit 2a.
8 Documented history of at least 2 asthma exacerbation events within 12 months before visit 1.
9 ACQ-6 score ≥1.5 at visit 1
10 Body weight ≥ 40 kg at visit 1.
You may not be if
1 Pulmonary disease other than asthma.
2 History of cancer.
3 Current smokers or subjects with smoking history ≥10 pack-years.
4 Hepatitis B, C, human immunodeficiency virus (HIV) or Syphilis.
5 History of anaphylaxis following any biologic therapy.
6 History of chronic alcohol or drug abuse within 12 months.
7 History of a clinically significant infection.
8 Pregnant or breastfeeding.
Clareo Health | Evaluate the Efficacy and Safety of TQC2731 Injection in Patients With Severe Asthma.
