Perennial allergic rhinitis (PAR) Ear, Nose and Throat
Conditions
Interventions
Subjects who meet all eligible requirements for entry into the study will be randomized into one of the four treatment groups in 1:1:1:1 ratio as shown below:
1. One capsule of Lactoba
Sponsors
GenMont Biotech (Taiwan)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with age of 5-16 years old (inclusive) 2. Subjects with a history of PAR for at least 1 year 3. Subjects with either one of the following test results (test results within 12 months before study are acceptable) 3.1. Positive skin-prick test reaction (wheal ?3mm larger than the diluents control) 3.2. Positive reaction determined by the CAP or MAST(Multiple allergosorbent test) system 4. Subjects with mean NTSS of no less than 5 throughout the screening period (4 to 10 days); at least 4 days should be recorded during the screening period; and the NTSS of the day before day-0 (first dosing day) visit is no less than 5 5. Subjects’ parents or their legally acceptable representatives have signed the written informed consent form
Exclusion criteria
Exclusion criteria: 1. Subjects have clinically significant abnormalities laboratory results as determined by the investigator (Tests performed during 14 days prior to Visit 1 or during baseline period can be used for evaluating this criterion) 2. Subjects with acute or significant chronic sinusitis, severe persistant asthma, congenital immunodeficiency, neuropsychiatric disorders, immune-compromised massive wound in the oral cavity, use of rhinitis medications, and chronic use of tricyclic antidepressants 3. Subjects who need to take prohibited medications during the study or took the medications within 30 days prior to the screening visit: - Parenteral or oral corticosteroids - Nasal corticosteroids - Topical use of flurandrenolide - Topical use of clobetasol propionate - Topical use of halobetasol propionate - Astemizole - Ketotifene - Nedocromil or Sodium cromoglycate - Loratadine - Cetirizine - Antileukotrienes - Other H1 antihistamine - Nasal decongestant - Any food supplements including LP(Lactobacillus paracasei) 4. Subject is undergoing desensitization therapy within 3 months prior to the screening visit or with vasomotor rhinitis 5. Subject participated investigational drug trial within 4 weeks before entering this study 6. Patients are pregnant or lactating or plans to become pregnant 7. Subjects with any other serious disease considered by the investigator not in the condition to enter the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose response of LPmeasured using net change in mean NTSS (Nasal Total Symptom Score) at the 12th week treatment visit (compared to baseline). NTSS is recorded daily by the patients using a DRC (Daily Record Card). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Net change of the 2nd, 4th, and 8th week evaluations compared to the baseline on NTSS 2. Net change of the 2nd, 4th, 8th and 12th week evaluations compared to the baseline on each individual symptom score rated in the NTSS items 3. Net change of the 2nd, 4th, 8th and 12th week evaluations compared to the baseline on NTSS by investigator’s evaluation at site 4. Net change of the 2nd, 4th, 8th and 12th week evaluations compared to the baseline on each individual symptom score rated by NTSS by investigator’s evaluation at site 5. Global assessment by the investigator as categorized into 4 levels of complete relief, partial relief, no relief, worse. 6. Net change of the serum interferon-? (IFN-?) concentration during the treatment period (IFN-? at Visit 6 – IFN?at baseline) 7. Net change of the serum total IgE (Immunoglobulin E) concentration during the treatment period (IgE at baseline-IgE at Visit6) Safety endpoints: 1. Vital signs change: The vital signs including blood pressure, pulse rate, respiratory rate and body temperature will be assessed for changes compared to baseline 2. Adverse event incidence: Adverse event will be recorded for each of the visits starting from the baseline visit 3. Physical examination changes: physical examinations will be performed for the 4th and 12th week visit. Changes in physical examination results for these two during-treatment visit will be considered as one of the safety observations. 4. Blood laboratory test result changes: The blood laboratory tests including the following items will be tested periodically: WBC (White blood cell) with differential counts, RBC (Red Blood Cell), hemoglobin, hematocrit, platelet , MCV (Mean Corpuscular Column), MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), AST (Aspartate aminotrans | — |
Countries
Taiwan
Contacts
Public ContactFang-Kuei;Wan-Hua Lin;Tsai
;
Outcome results
None listed