Phase II/III Clinical Trial of TO-203 -Efficacy and Safety Trial in Patients with HDM-induced Asthma

Phase 2

• Conditions: HDM-induced asthma

• Registration Number: JPRN-jRCT2080221805
• Lead Sponsor: TORII PHARMACEUTICAL CO., LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 900

Inclusion Criteria

(1) HDM-specific IgE antibodies >= Class 3
(2) Positive HDM-allergen scratch or prick test
(3) Asthmatic symptoms were treated with ICS
(4) Dicumented reversible airway obstruction
(5) FEV1 > 70% of the predicted value

Exclusion Criteria

(1) Patients who have perennial symptoms of asthma or rhinitis due to regular exposure to antigens (excluding HDM).
(2) Patients who received immunotherapy with HDM allergen-containing products (e.g., house dust) for at least 1 month during 5 years before the first day of observation.
(3) Patients who are on immunotherapy other than HDM allergen-containing products on the first day of observation.
(4) Patients with a history of serious adverse drug reactions due to immunotherapy.
(5) Patients who were hospitalized due to worsening of asthma within 3 months before the first day of observation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified