A Comparison of the Efficacy and Safety between Ramatroban (BAY u 3405) and Terfenadine on Perennial Allergic Rhinitis -A Phase M, Randomized, Double-blind, Parallel Group, Comparative Study-

IntroductionSo-Cheong-Ryong-Tang (SCRT) is a herbal medicine widely used in traditional medicine for treating allergic rhinitis (AR). In animal studies, SCRT has suppressed the progression of AR. The main purpose of this study is to assess the efficacy and safety of the SCRT for the treatment of perennial allergic rhinitis (PAR) and discover the underlying mechanisms resulting in anti-inflammatory effects in humans.Methods and analysisWe will conduct a double-blind, randomised, placebo-controlled, parallel-group, multicentre trial of Korean adults with PAR. For the study, 156 subjects with PAR will be recruited. The trial will consist of a 4-week oral administration of SCRT or placebo with two visits at 2-week intervals and an 8-week follow-up period with two visits at 4-week intervals. The primary outcome is a change in the total nasal symptoms score. The secondary outcomes include changes in the Rhinoconjunctivitis Quality of Life Questionnaire score, total serum IgE and cytokines levels.Ethics and disseminationThis study was approved by the Institutional Review Board at each research centre (name of each centres and approval numbers): Kyung Hee University Hospital at Gangdong (KHNMC-OH-IRB 2015-04-009), Kyung Hee University Medical Centre (KOMCIRB-160321-HRBR-011), Pusan National University Hospital (2016–004), Dongguk University Medical Centre (2016–03) and Semyung University hospital (2016–01). This result will be published in a peer-reviewed journal.Trial registration numberNCT03009136; Pre-results.

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Phase 3, single-center, sequential and parallel-group, double-blind, randomized study evaluating the efficacy and safety of Fexofenadine Hydrochloride 180 mg (Allegra®/Telfast®) versus placebo in subjects suffering from Allergic Rhinitis with symptoms aggravated in presence of pollutants: analysis of individual symptom scores

World Allergy Organization Journal ◽

10.1016/j.waojou.2020.100266 ◽

2020 ◽

Vol 13 (8) ◽

pp. 100266

Author(s):

Anne K. Ellis ◽

Margarita Murrieta-Aguttes ◽

Sandy Furey ◽

Christopher Carlsten

Keyword(s):

Allergic Rhinitis ◽

Randomized Study ◽

Efficacy And Safety ◽

Single Center ◽

Phase 3 ◽

Double Blind ◽

Parallel Group ◽

Symptom Scores

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A Parallel-Group Comparison of Astemizole and Loratadine for the Treatment of Perennial Allergic Rhinitis

Journal of International Medical Research ◽

10.1177/030006059702500401 ◽

1997 ◽

Vol 25 (4) ◽

pp. 175-181 ◽

Cited By ~ 66

Author(s):

H Al-Muhaimeed

Keyword(s):

Allergic Rhinitis ◽

Statistical Significance ◽

Double Blind Study ◽

Perennial Allergic Rhinitis ◽

Double Blind ◽

Once Daily ◽

Runny Nose ◽

Parallel Group ◽

The Mean ◽

To Receive

The efficacy and safety of the two antihistamines, astemizole and loratadine, were compared in a double-blind study of 84 patients with perennial allergic rhinitis. Patients were randomized to receive orally either astemizole 10 mg once daily ( n = 40) or loratadine 10 mg once daily ( n = 44) for 1 week. No other antirhinitis medication was allowed during the study. By day 7 the mean daily symptom scores, recorded on diary cards, were lower in patients receiving astemizole than in those receiving loratadine for runny nose, itchy nose and sneezing, although not for blocked nose, and treatment differences only reached statistical significance for runny nose. After 7 days, 53.75% of patients on astemizole and 38.6% on loratadine were free of symptoms, and 87% of patients on astemizole described the treatment as good or excellent compared with 62% on loratadine. The present results suggest that astemizole may be more effective than loratadine in controlling symptoms of perennial allergic rhinitis.

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