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

JRCT ID: jRCTs031210276

Registered date:26/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Japanese cedar pollinosis
• Date of first enrollment: 27/08/2021
• Target sample size: 40
• Study type: Interventional

Intervention(s)

1 group
In Visit 3 one Pranlukast hydrate capsule (Onon capsule 112.5 mg) is administered to 4 subjects 60 minutes before exposure to Japanese cedar pollen.
2 groups
In Visit 3 one placebo capsule is administered to 36 subjects 60 minutes before exposure to Japanese cedar pollen

Outcome(s)

• Primary Outcome: Total 3 nasal symptom scores (sneezing, nasal discharge and nasal congestion scores: 3TNSS) during 120 to 180 minutes after the exposure of cedar pollen.

Secondary Outcome

Following symptom scores during 120-180 minutes after the exposure of cedar pollen
1)Total 4 nasal symptom scores (sneezing, nasal discharge, nasal congestion and itchy nose scores: 4TNSS)
2)Individual nasal symptom scores (sneezing, nasal discharge, nasal congestion and itchy nose scores)
3)Total non-nasal symptom scores (itchy eyes and watery eyes scores: TNNSS)
4Individual eye symptom scores (itchy eyes and watery eyes scores)
5)Total symptom score (TSS)
6)Total nasal symptom medication score (TNSMS)
7)Total non-nasal symptom medication score (TNNSMS)
8)Total symptom medication score (TSMS)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Takazawa Kenji
• Source(s) of Monetary Support: Immunomic Therapeutics, Inc.