Healthy male/female adults
Conditions
Interventions
Spray/inhalation of the test aerosol to the subjects for eight weeks (not less than 4 hours, but no more than 8 hours a day).
Spray/inhalation of the placebo aerosol to the subjects for eight weeks (n
Sponsors
CPCC Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male/female subjects ranging in age from 20 to 64 at informed consent. (2) Subjects fully realized that the subjects themselves must be in perennial allergic rhinitis. (3) Subjects who can spray and inhale the test aerosol in their non-ventilating private room which is not bigger than 25.54 m2, for not less than 4 hours, but no more than 8 hours a day during this trial. (4) Subjects who can avoid ventilating (except using an air-conditioner) and masking, during the spray/inhalation periods. (5) Subjects who can give informed consent to take part in this trial, after being provided with an explanation of our experimental protocol detail.
Exclusion criteria
Exclusion criteria: (1) Subjects with current/previous medical history of serious diseases in respiratory system. (2) Throughout this trial, subjects who take steadily in affecting medicines/foods/supplements. (3) Subjects being under some kind of medical treatment, or planning to be treated during this trial. (4) Subjects with previous/current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (5) Subjects with excessive alcohol intake. (6) Pregnant, possibly pregnant, and lactating women. (7) Subjects having a drug/chemical allergy. (8) Subjects being under another clinical test with medicines and/or health foods, or participated in that within four weeks before this trial, or planning to take part in that after giving informed consent to participate in this trial. (9) Subjects who are planning to be treated for allergic rhinitis, and take steadily in antiallergic oral medicines, during this trial. (10) All the year around, subjects who take steadily in oral medicines, eye drops and nasal spray, corresponding to antihistamines and antiallergics. (11) Throughout this trial, subjects who have any difficulty in refraining from inhaling another antiseptic aerosol, which might affect the test results. (12) Subjects who donated their blood components and/or whole blood (200 mL) within a month to this trial. (13) Males who donated their whole blood (400 mL) within the last three months to this trial. (14) Females who donated their whole blood (400 mL) within the last four months to this trial. (15) Males who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial. (16) Females who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial. (17) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| JRQLQ-questionnaire scores about nasal symptoms (the total number of the points from "snivel", "sneeze", "stuffy" and "itch") | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Allergy seriousness-sorting questionnaire scores about nasal symptoms (the maximum value from "sneeze frequency a day", "blow frequency a day" and "stuffy" in a life-diary record) 2. JRQLQ-questionnaire scores about eye symptoms (the total number of the points from "itch" and "watery") 3. Non-specific IgE concentration in serum 4. Specific IgE concentration (e.g., tick and house dust) in serum 5. Subjective symptoms concerning physical condition | — |
Countries
Japan
Contacts
Public ContactMitsuhiro Fujimoto
CPCC Company Limited Clinical Planning Department
Outcome results
None listed