TK-042 Phase III Clinical Study Long-term administration study in children with perennial allergic rhinitis

Teikoku Seiyaku Co., Ltd.0 个研究点目标入组 60 人开始时间: 2024年7月13日最近更新: 2024年9月11日

适应症

试验速览

暂无简介。

•>= 7 to < 12 years of age.
•Have positive (class >= 2) specific IgE antibodies test (e.g., CAP-RAST, AlaSTAT 3g, etc.) for antigens of perennial allergic rhinitis.

•Have concomitant nasal disorders (e.g., nasal polyps, nasal septum deviation, hypertrophic rhinitis, etc.) or infectious diseases (e.g., upper respiratory tract inflammation, sinusitis, infectious rhinitis, eye infections, etc.) to a degree that would interfere with the efficacy evaluation.
•Have non-allergic rhinitis (e.g., vasomotor, infectious, drug-induced, etc.) or history of non-allergic rhinitis.
•Have undergone coagulation (e.g., laser) or ablative surgery for the treatment of nasal symptoms within 1 year prior to obtaining consent.
•Have uncontrolled mild and moderate bronchial asthma (patients with conditions that require the use of injectable, oral, or inhaled steroid preparations), or severe bronchial asthma.
•Have a history of hypersensitivity to antihistamines, including this drug, or any ingredient of investigational drugs.
•Have severe hepatobiliary disorders.
•Have severe renal or urinary disorders.

Safety endpoints (laboratory tests, vital signs, adverse events)

未报告次要终点

发起方