Health Condition 1: J01- Acute sinusitis
Conditions
Interventions
Intervention1: Fenspiride 80mg: Fenspiride 80mg thrice in a day for 10 days
Control Intervention1: Placebo: placebo thrice in a day
Sponsors
Zuventus Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 b.individual score for facial pain/pressure >= 1 (mild) and c.confirmed by CT scan of paranasal sinuses d.with presence of symptoms 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Timepoint: 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
| Measure | Time frame |
|---|---|
| [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 periodTimepoint: within 10 days of treatment duration | — |
Countries
India
Contacts
Public ContactDr Bhupesh Dewan
Zuventus Healthcare Ltd
Outcome results
None listed