4week, a Multicenter, Randomized, Double-blinded, Parallel, Therapeutic confirmatory Clinical Trial to Evaluate the Efficacy and Safety of HL151 versus Placebo in perennial allergic rhinitis patients(Phase 3 )
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0003974
- Lead Sponsor
- Hanlim Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 272
1) Men and women aged 19 years or older
2) Subjects who had a history of perennial allergic rhinitis for at least 2 years prior to study participation
3) Subjects who had positive reactions to perennial allergens in allergy skin tests (e.g., skin prick test or intradermal test), MAST, or ImmunoCAP that were conducted within 12 months
However, the criteria for positive responses to specific allergens in the prick test, intradermal test, Mmultiple allergen Simultaneous Test,MAST) , or ImmunoCAP are defined as follows.
- Prick tests: a wheal size of = 3 mm, compared with the diluent control
- Intradermal tests: a wheal size of = 7 mm, compared with the diluent control
- MAST or ImmunoCAP: = Class 2
4) Subjects who had an average daily reflective Total Nasal Symptom Score(r-TNSS) of = 5 (maximum=12) at Visit 2 during the 1-week run-in period
5) Subjects who had the ability and willingness to record subject diaries
6) Subjects who agreed to equally maintain surrounding environment during the entire period of the clinical study
7) Subjects who voluntarily agreed to participate in this clinical study in written form
1) Subjects with non-allergic (angioneurotic, infectious, and drug-induced) rhinitis
2) Patients with severe asthma corresponding to the following cases (However, patients with mild and intermittent asthma can participate in the clinical study.)
- Patients who visited an emergency room within 4 weeks from the screening date, or entered into a hospital within 12 weeks form the screening date
- Patients with asthma who require other treatment drugs, except a short-acting beta-agonist bronchodilator inhaler
3) Subjects with clinically significant nasal deformities, such as obstructive nasal polyps or nasal septum
4) Subjects who experienced damages around the nasal cavity or surgeries within 12 weeks of Visit 1
5) Subjects with the past medical history of acute or chronic sinusitis within 4 weeks of Visit 1
6) Subjects who initiated immunotherapy or changes in dosage within 4 weeks of Visit 1
7) Subjects who experienced use of long-acting antihistamines
8) Subjects with upper respiratory tract infections including the common cold, and systemic infections within 2 weeks of Visit 1
9) Subjects with comorbidities that may interrupt the treatment of cancers or clinical significant disorders of the kidney, liver, psychiatric system, cardiovascular system, respiratory system, endocrine system, and central nervous system, the safety assessment, or completion of this clinical study
10) Patients with abnormal renal function [Creatinine clearance (CLCR) < 30 mL/min]
11) Patients with severe abnormal liver function tests [Alanine transaminase (ALT) or Aspartate transaminase (AST) values = 2 times the upper limit of normal (ULN)]
12) Subjects with the use of concomitant medications, or those who are expected to need the use of prohibited concomitant medications during the period of the clinical study (With the exception of the case that the following minimal period after the use of concomitant medications passed.)
- Nasal passages, topical, eye drops or systemic antihistamines: 3 days [However, 10 days for long-acting agents (e.g., loratadine, fexofenadine, and cetirizine), 14 days for ketotifen, and 3 months for astemizole]
- Cromolyn nasal, or nedocromil: 14 days
- Anticholines: 3 days
- Nasal or systemic decongestants: 3 days
- Nasal or systemic corticosteroids: 30 days
- Reserpine: 3 days
- Antitussives and expectorants: 3 days
- Leukotriene modifiers: 7 days
- Systemic antibiotics: 14 days
- Nonsteroidal anti-inflammatory drugs (NSAIDs): 2 days (However, a low-dose aspirin (below 100mg) can be used.)
- Traditional herbal medicinal products that may affect rhinitis and eye symptoms: 14 days
13) Subjects who chronically used tricycle antidepressants, beta-agonists, and bronchodilators that may affect the efficacy of test drugs
14) Subjects whose morning reflective TNSS during the baseline period within 1 week of Visit 2 was recorded for less than 4 days
15) Subjects with a plan of long-term movement to other areas during the period of the clinical study
16) Subjects with a history of excessive alcohol use or drug addition
17) Subjects with a history of hypersensitivity reaction to active ingredients or excipients of the investigational product
18) Subjects with genetic disorders, such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
19) Subjects who did not agree to use contraception by medically permitted methods (e.g., surgical treatment of infertility, intrauterine device, condom or diaphragm, and inject
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in total rTNSS(Reflective TNSS) score at 4 weeks after clinical drug administration compared to baseline
- Secondary Outcome Measures
Name Time Method Changes in rTNSS(Reflective TNSS) score at 2 weeks after clinical drug administration compared to baseline;Changes in iTNSS(Instananeous TNSS) score at 2 weeks and 4 weeks after clinical drug administration compared to baseline;Changes in rTNSS(Reflective TNSS) score (Information recorded in the TNSS section of the diary included-Runny Nose,Sneezing,Itchy)at 2 weeks and 4 weeks after clinical drug administration compared to baseline;Changes in iTNSS(Instananeous TNSS) score (Information recorded in the TNSS section of the diary included-Runny Nose,Sneezing,Itchy) at 2 weeks and 4 weeks after clinical drug administration compared to baseline;Investigator's assessment of overall treatment