A multi-centric, placebo controlled, randomized, double-blind clinical trial to evaluate the efficacy and safety of Fenspiride in acute rhinosinusitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Primary Outcome
研究概览
简要总结
Title:
A multi-centric, placebo controlled, randomized, double-blind clinicaltrial to evaluate the efficacy and safety of Fenspiride in acuterhinosinusitis.
Study Phase:
Phase III
Objectives:
The aim of thisclinical study is to investigate the efficacy of a 10 day treatment withfenspiride for therapy of acute rhinosinusitis (ARS) in adult patients.
Primary Objective
The primary objectiveis to assess the efficacy of fenspiride in relief of clinical symptoms of ARS.
Secondary Objective
The secondaryobjectives of this trial include
1. To assess the efficacy of fenspiride inresolution of the clinical symptoms of ARS.
- Toevaluate the safety of the investigational drug.
Study Design:
Multi-centric, Randomized, Double Blind, placebocontrolled, parallel-group study.
Estimated Sample Size: 120
Study endpoints:
Primary Outcome
The primary outcomes in the studyinclude
[1] Symptom improvement: Defined as symptom scores less than or equal to 1 (i.e., mild or nosymptoms) for all 5 major symptoms (rhinorrhea (anterior discharge), postnasaldrip, nasal congestion, headache, facial pain/pressure) for MSS on Day 5 andDay 10.
[2] Percentage of patients with signs ofacute rhinosinusitis in CT scan of paranasal sinuses before and after therapy.
[3] Reduction in SNOT 20 symptom scoresafter Day 5 and Day 10 of treatment.
Secondary Outcome
The various secondary outcomes ofthis study include
[1] Proportionof patients with complete remission, defined a score of 0 for all 5 majorsymptoms: rhinorrhea (anterior discharge), postnasal drip, nasal congestion,headache, facial pain/pressure.
[2] MeanChange from baseline over the entire treatment period in MSS: Change frombaseline in MSS will be calculated as the MSS averaged over the entiretreatment period minus the MSS over the baseline period (defined as the averageMSS over the last 3 days prior to randomization).
[3] Timeto onset of action: Deï¬ned as the ï¬rst day of active treatment on which S5scoring was statistically signiï¬cantly different from placebo and sustainedthereafter.
[4] Theproportion of patients who require the use of an antibiotic due to thedevelopment of FBRS (Fulminant Bacterial Rhinosinusitis) during the 10 Daytreatment period.
[5] Assessmentof therapy by investigator and patients at the end of the 10 Day treatment.
[6] Adverse events reported bythe patients during the 10 Day treatment period.
| Test Product : |
Fenspiride (80 mg t.i.d) for 10 days
|Comparator:
Placebo t.i.d for 10 days
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female patients aged 18 years or older.
- •2.Diagnosed of acute rhinosinusitis which is a.characterized by a major symptom score (MSS) ≥ 8 and ≤ 12 points (minimum 0, maximum 15 points) b.individual score for facial pain/pressure ≥ 1 (mild) and ≤ 2 (moderate) c.confirmed by CT scan of paranasal sinuses d.with presence of symptoms ≤ 3 days prior to inclusion 3.Not diagnosed and treated with antibiotics within the last 7 days.
- •4.Patients willing to give written informed consent and willing to comply with trial protocol.
排除标准
- •1.Diagnosis of chronic rhinosinusitis at the time of screening.
- •2.Serious malformations in the nose and sinuses 3.Polyposis nasi 4.Anatomical deviations of the nasal septum that significantly impair nasal and paranasal ventilation/airflow 5.Patients with asthma who have a history of exacerbations within 30 days prior to study inclusion.
- •6.Signs or symptoms of fulminant bacterial sinusitis (fever ≥101oF/38.3oC, persistent severe unilateral facial or tooth pain, facial swelling, dental involvement, or a worsening of symptoms after initial improvement) 7.Odontogenic sinusitis 8.Chronic diseases such as cystic fibrosis, respiratory tract allergy, immune deficiency and diabetes.
- •9.Illness severe enough to require hospitalization 10.History of allergy to fenspiride.
结局指标
主要结局
Primary Outcome
时间窗: Primary Outcome | [1]Symptom improvement: Defined as symptom scores less than or equal to 1 (i.e., mild or no symptoms) for all 5 major symptoms (rhinorrhea (anterior discharge), postnasal drip, nasal congestion, headache, facial pain/pressure) for MSS on Day 5 and Day 10. | [2]Percentage of patients with signs of acute rhinosinusitis in CT scan of paranasal sinuses before and after therapy. | [3]Reduction in SNOT 20 symptom scores after Day 5 and Day 10 of treatment.
[2]Percentage of patients with signs of acute rhinosinusitis in CT scan of paranasal sinuses before and after therapy.
时间窗: Primary Outcome | [1]Symptom improvement: Defined as symptom scores less than or equal to 1 (i.e., mild or no symptoms) for all 5 major symptoms (rhinorrhea (anterior discharge), postnasal drip, nasal congestion, headache, facial pain/pressure) for MSS on Day 5 and Day 10. | [2]Percentage of patients with signs of acute rhinosinusitis in CT scan of paranasal sinuses before and after therapy. | [3]Reduction in SNOT 20 symptom scores after Day 5 and Day 10 of treatment.
[1]Symptom improvement: Defined as symptom scores less than or equal to 1 (i.e., mild or no symptoms) for all 5 major symptoms (rhinorrhea (anterior discharge), postnasal drip, nasal congestion, headache, facial pain/pressure) for MSS on Day 5 and Day 10.
时间窗: Primary Outcome | [1]Symptom improvement: Defined as symptom scores less than or equal to 1 (i.e., mild or no symptoms) for all 5 major symptoms (rhinorrhea (anterior discharge), postnasal drip, nasal congestion, headache, facial pain/pressure) for MSS on Day 5 and Day 10. | [2]Percentage of patients with signs of acute rhinosinusitis in CT scan of paranasal sinuses before and after therapy. | [3]Reduction in SNOT 20 symptom scores after Day 5 and Day 10 of treatment.
[3]Reduction in SNOT 20 symptom scores after Day 5 and Day 10 of treatment.
时间窗: Primary Outcome | [1]Symptom improvement: Defined as symptom scores less than or equal to 1 (i.e., mild or no symptoms) for all 5 major symptoms (rhinorrhea (anterior discharge), postnasal drip, nasal congestion, headache, facial pain/pressure) for MSS on Day 5 and Day 10. | [2]Percentage of patients with signs of acute rhinosinusitis in CT scan of paranasal sinuses before and after therapy. | [3]Reduction in SNOT 20 symptom scores after Day 5 and Day 10 of treatment.
次要结局
- [1]Proportion of patients with complete remission, defined a score of 0 for all 5 major symptoms: rhinorrhea (anterior discharge), postnasal drip, nasal congestion, headache, facial pain/pressure.([2]Mean Change from baseline over the entire treatment period in MSS: Change from baseline in MSS will be calculated as the MSS averaged over the entire treatment period minus the MSS over the baseline period)