A Randomized, Observation Study to Evaluate the Demographics and Characteristics of Japanese Patients With Cedar Pollinosis Using an OHIO Chamber

Phase 2

• Conditions: Japanese cedar pollinosis

• Registration Number: JPRN-jRCTs031210276
• Lead Sponsor: Takazawa Kenji

Brief Summary

The most important finding from this study was that the chamber-based trial yielded clinically significant endpoints with variability while it was critical to establish robust clinical hypotheses for setting the number of cases associated with the primary endpoint in clinical development. Based on the data obtained and the information used in the clinical development plan, the client prepares a scenario for clinical development.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-26
• Study Completion: 2021-10-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Patients who provide written consent using the informed consent form approved by the CRB of the study site before starting any study-related procedure
2.Patients of either sex who is aged from 20 to 64 years at the time of informed consent
3.Patients who have documented nasal symptoms (sneezing, nasal discharge or nasal congestion) and eye symptoms (itchy eyes or watery eyes) of pollinosis during a cedar pollen dispersal season between 2018 and 2020
4.Patients who have a JRC pollen-specific IgE antibody test result of Class 3 or higher within recent 10 years and who agrees to be tested for IgE antibodies specific to JRC pollen and other allergens at the time of informed consent and at the end of the study
5.Patients who can agree not to participate in another intervention study for Japanese cedar pollinosis during the study period

Exclusion Criteria

1 Patients who have used the following drugs within 2 weeks prior to study participation or will use these drugs during the observation period:
1)topical steroid,
2)histamine H1-receptor antagonist other than the study drug
3)chemical mediator-isolation inhibitor
4)Th2 cytokine inhibitor, thromboxane A2 synthesis inhibitor
5)thromboxane A2 receptor antagonist
6)leukotriene receptor antagonist
2 Patients who have received specific immunotherapy (including desensitization therapy) for cedar pollinosis in the past
3 Patients who have received specific or non-specific immunotherapy within 5 years prior to study participation
4 Patients who have received laser therapy/surgery for treating nasal symptoms within 3 years prior to study participation
5 Patients who have used the following drugs within 12 weeks prior to study participation
1)biological agents, such as antibiotics (anti-tumor necrosis factor alpha antibody anti-IgE monoclonal antibody, etc.)
2)systemic steroids and immunosuppressants (use of medications for external use on the skin are allowed.)
6 Patients who have received vaccination with a live vaccine or with an inactivated vaccine/toxoid within 4 weeks prior to study participation or are planning to receive those vaccinations during the observation period
7 Patients who have participated in any clinical study or post- marketing clinical study with any other medical drug or device within 4 weeks prior to study participation or patients who are participating in such a study at present
8 Patients who have any condition and/or severe medical complication (e.g., hepatic, renal, respiratory, cardiovascular and metabolic, psychiatric disease, active cancer) that could interfere with, or for which the treatment might interfere with, the conduct of the study or interpretation of the study results, or that would in the opinion of the investigator increase the risk of participating in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified