NCT04132570已完成4 期
A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Intranasal Budesonide Aqueous Spray for Treatment of Rhinitis During Periods of High Airborne Pollution
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division6 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2019年10月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 206
- 试验地点
- 6
- 主要终点
- Mean Change from Baseline in 24-hour Reflective Total Nasal Symptom Score (rTNSS)
研究概览
简要总结
The primary objective of this study is to assess the effectiveness of intranasal budesonide aqueous spray 256 microgram (mcg)/day for treatment of rhinitis symptoms during times of high airborne pollution.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blind
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
- •Self-reported rhinitis symptoms triggered or worsened by airborne pollution, with agreement by physician at screening visit
- •Participant must have moderate to severe rhinitis symptoms as defined by a 24-hour reflective total nasal symptom score (rTNSS) of at least 5 (maximum 9), based on three individual nasal symptom scores (nasal obstruction, secretion/runny nose, itching/sneezing) at the time of the screening visit, including at least one individual symptom score of 3 for nasal obstruction and/or secretion/runny nose
- •Regularly have outdoor exposure during a normal week in the winter season, including greater than or equal to (>=) 1 hour on most days. Outdoor exposure may include commuting activities (such as walking/bicycle/auto/bus/city metro train travel), outdoor work, exercise, shopping, or other outdoor activities
- •A woman of childbearing potential must have a negative urine pregnancy test (beta human chorionic gonadotropin [beta hCG]) at screening and agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 30 days after the last administration of study agent
- •Male participants who are not surgically sterilized and are heterosexually active with a woman of childbearing potential, must agree to use a barrier method of contraception (example condom with spermicidal foam/gel/film/cream/suppository) and to not donate sperm during the study and for 30 days after last receiving study agent. Note that barrier methods must also be used in all male subjects sexually active with pregnant partners for at least 30 days after last study agent administration
- •Participants can understand the questionnaires and are able to complete the questionnaires in the format provided
- •Reside in the same city as the study site that they will be visiting
排除标准
- •History of hypersensitivity to budesonide or any ingredients in the formulation
- •Upper respiratory infection within 2 weeks of screening visit
- •Current symptoms consistent with diagnosis of common cold, influenza, or other respiratory infection according to physician evaluation
- •Using of N-95 masks days during with high airborne pollution
- •Presence of nasal polyps or deviated septum as confirmed by nasal endoscopy
- •History of nasal surgery
- •Presence of chronic or active rhinosinusitis or sinusitis
- •Systemic, intranasal or topical corticosteroid use within 1 month, intranasal or systemic decongestants within 3 days, antihistamine use within 1 week, intranasal cromolyn within 2 weeks, leukotriene use within 1 month, or immunotherapy within 2 years of screening visit
- •Asthma, with the exception of mild intermittent asthma not requiring medication
- •Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (example compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
研究组 & 干预措施
Budesonide 256 mcg per Day (Treatment A)
Experimental
Participants will self-administer 2 nasal sprays of Budesonide (64 microgram [mcg]/spray) in each nostril once daily (every morning) up to 10 +\- 3 Days.
干预措施: Budesonide (Drug)
Placebo (Treatment B)
Placebo Comparator
Participants will self-administer 2 nasal sprays of matching placebo in each nostril once daily (in the morning) up to 10 +\- 3 Days.
干预措施: Placebo (Other)
结局指标
主要结局
Mean Change from Baseline in 24-hour Reflective Total Nasal Symptom Score (rTNSS)
时间窗: Baseline up to 10 days (24 hours each day)
Mean change from baseline in 24-hour reflective total nasal symptom score (rTNSS) calculated as the sum of the participant-assessed 24-hour reflective severity ratings for three individual nasal symptom scores (nasal obstruction, secretion/runny nose, itching/sneezing) averaged over the first 10-day treatment period. Baseline value will be a single 24-hour rTNSS recorded on the no-treatment evening following the baseline visit. The individual nasal symptom scores will be recorded at home by participants in their diary on a four point scale (from 0=none to 3=severe). The sum of the individual scores will form the 24-hour rTNSS.
次要结局
- Subject Global Impression of Change (SGIC) at the Final Efficacy Assessment(Day 10 (+/-3))
- Mean Change from Baseline in Individual Nasal Symptoms Scores (NSS)(Baseline to 10 days (24 hours each day))
- Mean Change from Baseline in 24-hour Reflective Individual non-Nasal Symptoms Score (Cough and Post-Nasal Drip)(Baseline to 10 days (24 hours each day))
- Number of Participants With Adverse Events (AEs) as a Measure of Safety(Up to Day 10 +/- 3 days or up to 30 days after the last day of the study treatment period (Day 10))
研究者
研究点 (6)
Loading locations...
相似试验
招募中
不适用
Effectiveness of budesonide nasal instillation in a vertex-to-floor position in chronic rhinosinusitis patients underwent endoscopic frontal sinus surgery: a randomized, controlled trial.chronic rhinosinusitis patients underwent endoscopic frontal sinus surgeryPost-frontal sinus operation cheonic rhinosinusitis patientBudesonide nasal instillationVertex-to-floor positionTCTR20151103001ืResearch Affairs, Faculty of medicine, Khonkaen University60
已完成
3 期
To Assess the Safety and Efficacy of Ciclesonide Applied as a Nasal Spray in the Treatment of Perennial Allergic Rhinitis (BY9010/M1-402)Rhinitis, Allergic, PerennialNCT00659750AstraZeneca418
已完成
3 期
To Assess the Safety and Efficacy of Ciclesonide, Applied as a Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (BY9010/M1-401)Rhinitis, Allergic, SeasonalHay FeverNCT00659841AstraZeneca302
已完成
3 期
Safety and Effectiveness of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis During One Year Treatment (BY9010/M1-404)Hay FeverAllergic RhinitisPerennial Allergic RhinitisNCT00163501AstraZeneca600
已完成
3 期
Safety and Effectiveness of Ciclesonide Nasal Spray in Children (6 to 11 Years) With Perennial Allergic Rhinitis (BY9010/M1-403)Hay FeverAllergic RhinitisPerennial Allergic RhinitisNCT00163514AstraZeneca636