| CTRI Number |
CTRI/2016/02/006668 [Registered on: 19/02/2016] Trial Registered Retrospectively |
| Last Modified On: |
04/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study of Fenspiride in inflammation of the sinuses, airspaces within the bones of the face |
|
Scientific Title of Study
|
A multi-centric, placebo controlled, randomized, double-blind clinical trial to evaluate the efficacy and safety of Fenspiride in acute rhinosinusitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZUV/FENS/ARS-01/2011-12 version 01 date May 02, 2011 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director Medical Services |
| Affiliation |
Zuventus Healthcare Ltd |
| Address |
Office No 5119 D Wing 5th Floor Oberoi Garden Chandivali Andheri East
Mumbai (Suburban)
MAHARASHTRA
400072
India |
| Phone |
022-30610000 |
| Fax |
|
| Email |
Bhupesh.Dewan@zuventus.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director Medical Services |
| Affiliation |
Zuventus Healthcare Ltd |
| Address |
Office No 5119 D Wing 5th Floor Oberoi Garden Chandivali Andheri East
Mumbai (Suburban)
MAHARASHTRA
400072
India |
| Phone |
022-30610000 |
| Fax |
|
| Email |
Bhupesh.Dewan@zuventus.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhupesh Dewan |
| Designation |
Director Medical Services |
| Affiliation |
Zuventus Healthcare Ltd |
| Address |
Office No 5119 D Wing 5th Floor Oberoi Garden Chandivali Andheri East
Mumbai (Suburban)
MAHARASHTRA
400072
India |
| Phone |
022-30610000 |
| Fax |
|
| Email |
Bhupesh.Dewan@zuventus.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Zuventus Healthcare Ltd |
| Address |
Office no 5119 D Wing 5th floor Oberoi Garden Estates Chandivali Andheri East Mumbai 400072 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr C Preetam |
All India Institute of Medical Sciences Bhubaneswar |
All India Institute of Medical Sciences, Sijua, Near Bijupatnayak Police Academy, Patrapada, Bhubaneswar, Odisha 751019
Khordha
ORISSA |
9438884166
preetam82@gmail.com |
| Dr K G Somashekara |
Kempegowda Institute of Medical Sciences |
Kempegowda Institute of Medical Sciences Athibabbe Road, Near BDA Complex, Banashankari 2nd Stage, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA |
9844024597
somashekara.kganesh@gmail.com |
| Dr B Ramchandra |
King George Hospital, Visakhapatnam |
King George Hospital, department of surgery Maharanipeta, Visakhapatnam-02
Visakhapatnam
ANDHRA PRADESH |
9848498488
rcentclinic2003@yahoo.com |
| Dr Renuka Bradoo |
Lokmanya Tilak Muncipal Medical College and General Hospital, Sion |
LTM Medical College and General Hospital, ground floor, ENT Department Sion, Mumbai-400022
Mumbai
MAHARASHTRA |
9820303788
rabradoo@gmail.com |
| Dr Jaimanti Bakshi |
Post Graduate Institute of Medical Education and Research |
PGIMER, department of Otolaryngology and head and neck surgery Sector-12,Chandigarh-160012
Chandigarh
CHANDIGARH |
914209764
bakshi.jaimanti@pgimer.edu.in |
| Dr S Ramesh |
Rajiv Gandhi Institute of Medical Sciences |
Rajiv Gandhi Institute of Medical Sciences Hudco Colony, Balaga, Srikakulam, Andhra Pradesh 532001
Srikakulam
ANDHRA PRADESH |
9490713477
rameshseepana@rediffmail.com |
| Dr R K Jenaw |
Sawai ManSingh Medical College |
Sawai ManSingh Medical College Jawaharlal Nehru Marg, Gangawal Park, Jaipur, Rajasthan 302004
Jaipur
RAJASTHAN |
9414051338
jenawrk@gmail.com |
| Dr Bachi Hathiram |
T. N. Medical College and B. Y. L. CH Nair hospital, Mumbai. |
T. N. Medical College and B. Y. L . Nair hospital, first floor, ENT department
Dr. A.C. Nair Road, Mumbai Central,
Mumbai- 400008
Mumbai
MAHARASHTRA |
09323699192
orlclinis@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ethics Committee, SMS Medical College and Attached Hospital |
Approved |
| Institutional Ethics Committee Lokmanya Tilak Municipal Medical College |
Approved |
| Institutional Ethics Committee of Topiwala National Medical College and BYL Nair Charitable Hospital |
Approved |
| Institutional Ethics Committee PGIMER |
Approved |
| Institutional Ethics Committee, AIIMS |
Approved |
| Institutional Ethics Committee, KIMS |
Approved |
| Institutional Ethics Committee, RIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J01||Acute sinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fenspiride 80mg |
Fenspiride 80mg thrice in a day for 10 days |
| Comparator Agent |
Placebo |
placebo thrice in a day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
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.
|
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
|
| Outcome |
TimePoints |
[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 |
within 10 days of treatment duration |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2015 |
| Date of Study Completion (India) |
19/09/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Title:
A multi-centric, placebo controlled, randomized, double-blind clinical
trial to evaluate the efficacy and safety of Fenspiride in acute
rhinosinusitis.
Objectives:
The aim of this
clinical study is to investigate the efficacy of a 10 day treatment with
fenspiride for therapy of acute rhinosinusitis (ARS) in adult patients.
Primary Objective
The primary objective
is to assess the efficacy of fenspiride in relief of clinical symptoms of ARS.
Secondary Objective
The secondary
objectives of this trial include
1. To assess the efficacy of fenspiride in
resolution of the clinical symptoms of ARS. 2. To
evaluate the safety of the investigational drug. Study Design:
Multi-centric, Randomized, Double Blind, placebo
controlled, parallel-group study. Estimated Sample Size: 120 Primary Outcome The primary outcomes in the study
include [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 The various secondary outcomes of
this study include [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 (defined as the average
MSS over the last 3 days prior to randomization). [3]
Time
to onset of action: Deï¬ned as the ï¬rst day of active treatment on which S5
scoring was statistically signiï¬cantly different from placebo and sustained
thereafter. [4]
The
proportion of patients who require the use of an antibiotic due to the
development of FBRS (Fulminant Bacterial Rhinosinusitis) during the 10 Day
treatment period. [5]
Assessment
of therapy by investigator and patients at the end of the 10 Day treatment.
[6] Adverse events reported by
the 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 |
|