Effects of Second-generation Antihistamine Bepotastine on Cough Outcomes in Cough Patients With Allergic Rhinitis: A Randomized, Double-blind, Placebo Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Leicester Cough Questionnaire (LCQ)
研究概览
简要总结
This is a phase 4 study to evaluate the the efficacy of second generation antihistamine on cough outcomes in cough patients with allergic rhinitis.
详细描述
This is a randomized, double blind, placebo controlled trial in which a total of 78 participants who have cough (≥ 3 weeks) and symptoms of allergic rhinitis will be enrolled. Study participants will be randomly assigned to either active treatment or placebo group. The subjects in active treatment groups will be treated with daily oral bepotastine for 2 weeks, while those in placebo group will take identical-looking tablets. The efficacy of bepotastine will be assessed at the end of 2-week intervention using leicester cough questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Allocation of medication is conducted by an independent physician who is not a co-investigator of the study.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Had a cough for at least 3 weeks (score of ≥30 mm on the VAS)
- •History or allergic rhinitis confirmed with skin prick test or serum specific IgE test AND current one or more symptoms of allergic rhinitis (runny nose, obstruction, sneezing, nasal itching)
- •Provided written informed consent
- •Were willing and able to comply with the study protocol
排除标准
- •Current smoker or individuals who have smoked within the past 1 month prior to study entry
- •Sings of coexisting respiratory diseases requiring active treatment such as fever, chills, wheezing, dyspnea, or purulent sputum
- •Currently under allergen immunotherapy
- •Allergic rhinitis or chronic rhinosinusitis under treatment with intranasal corticosteroids (INS) or leukotriene receptor antagonist (LTRA) or 2) allergic rhinitis requiring treatment with INS or LTRA
- •Treatment with an angiotensin converting enzyme (ACE)-inhibitor within 4 weeks prior to the enrollment
- •Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) < 0.7 or FEV1 % of predicted < 80% within 1 month prior to enrollment
- •Abnormal findings on chest x-ray related to cough within 1 month prior to enrollment
- •Diagnosis or treatment of bronchial asthma or COPD within 1 year of the enrollment
- •Clinically significant medical conditions possibly affecting evaluation of cough and nasal symptoms
- •History of hypersensitivity or severe adverse reaction to antihistamines
- •Unable to fill in the questionnaires (blindness, unable to read)
- •Unable to provide informed consent
- •History of taking following medication within 2 weeks of the enrollment; LTRA, nasal decongestants, intranasal corticosteroids (INS), systemic corticosteroids, antitussive agents (OTCs, codeine)
研究组 & 干预措施
Treatment group
Participants will be treated with bepotastine.
干预措施: Bepotastine (Drug)
Placebo group
Participants will be treated with identical looking placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Leicester Cough Questionnaire (LCQ)
时间窗: At baseline, and at 2 weeks of treatment
The total score range of Leicester Cough Questionnaire is from 3 to 21. A higher score indicates a better quality of life.
次要结局
- Visual analogue scale (VAS) of cough(At baseline, and at 2 weeks of treatment)
- Cough hypersensitivity questionnaire (CHQ)(At baseline, and at 2 weeks of treatment)
- Sino-nasal outcome test -22 (SNOT-22)(At baseline, and at 2 weeks of treatment)
- Visual analogue scale (VAS) of globus pharyngeus(At baseline, and at 2 weeks of treatment)
- Daily cough severity(daily assessment)
- Rate of adverse events(during 2 weeks of treatment)
- Objective cough frequency(At baseline, and at 2 weeks of treatment)
研究者
Woo-Jung Song
Professor
Asan Medical Center