Study of Fenspiride in inflammation of the sinuses, airspaces within the bones of the face
- Conditions
- Acute sinusitis,
- Registration Number
- CTRI/2016/02/006668
- Lead Sponsor
- Zuventus Healthcare Ltd
- Brief Summary
**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.
2. 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome 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. 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. 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. 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.
- Secondary Outcome Measures
Name Time Method [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
Trial Locations
- Locations (8)
All India Institute of Medical Sciences Bhubaneswar
🇮🇳Khordha, ORISSA, India
Kempegowda Institute of Medical Sciences
🇮🇳Bangalore, KARNATAKA, India
King George Hospital, Visakhapatnam
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Lokmanya Tilak Muncipal Medical College and General Hospital, Sion
🇮🇳Mumbai, MAHARASHTRA, India
Post Graduate Institute of Medical Education and Research
🇮🇳Chandigarh, CHANDIGARH, India
Rajiv Gandhi Institute of Medical Sciences
🇮🇳Srikakulam, ANDHRA PRADESH, India
Sawai ManSingh Medical College
🇮🇳Jaipur, RAJASTHAN, India
T. N. Medical College and B. Y. L. CH Nair hospital, Mumbai.
🇮🇳Mumbai, MAHARASHTRA, India
All India Institute of Medical Sciences Bhubaneswar🇮🇳Khordha, ORISSA, IndiaDr C PreetamPrincipal investigator9438884166preetam82@gmail.com