| CTRI Number |
CTRI/2012/08/002941 [Registered on: 31/08/2012] Trial Registered Retrospectively |
| Last Modified On: |
11/11/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to evaluate the efficacy and safety of 2 study drugs in treatment of patients with allergic rhinitis |
|
Scientific Title of Study
|
A randomized, open label, prospective, two arm, comparative multicentric study to evaluate the efficacy and safety of montelukast and fexofenadine fixed dose combination vs montelukast and levocetirizine fixed dose combination in the management of patients with allergic rhinitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MONTI-FX- AHPL / 03 / 2012, Version - 1: dated 01 - 03 - 12 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
DrManoj Naik |
| Designation |
Chief Manager Clinical Research |
| Affiliation |
Abbott Healthcare Pvt Ltd |
| Address |
D-Mart Building, Goregaon Mulund Link Road, Mulund (W), Mumbai
Mumbai
MAHARASHTRA
400080
India |
| Phone |
022-39536910 |
| Fax |
022-39536665 |
| Email |
manoj.naik@abbott.in |
|
Details of Contact Person
Public Query
|
| Name |
MrManoj Prabhu |
| Designation |
Manager Clinical Research |
| Affiliation |
Abbott Healthcare Pvt Ltd |
| Address |
D-Mart Building, Goregaon Mulund Link Road, Mulund (W), Mumbai
Mumbai
MAHARASHTRA
400080
India |
| Phone |
022-39536910 |
| Fax |
022-39536665 |
| Email |
manoj.prabhu@abbott.in |
|
|
Source of Monetary or Material Support
|
| Abbott Healthcare Pvt Ltd, Mumbai |
|
|
Primary Sponsor
|
| Name |
Abbott Healthcare Pvt Ltd |
| Address |
D-Mart Building, Goregaon Mulund Link Road , Mulund (W), Mumbai- 400080 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrCVSrinivas |
Gowri Prasana Diabetes & Heart Care Centre |
Department of ENT , 2nd cross, opp 10th Hennur Busstop, Kalyan nagar post, Bangalore
Bangalore
KARNATAKA |
080-25459599
game_sri@yahoo.com |
| DrMVJagde |
Grant Government Medical College |
Department of ENT, Sir JJ Group of Hospitals,Byculla Mumbai- 400008
Mumbai
MAHARASHTRA |
022-23735555
mvjagde@gmail.com |
| DrPrateek Nayak |
Pace Clinical Research Centre |
DEpartment of ENT, 57/1, Nanda Complex, Banswadi,Rama murthy nagar main road, Bangalore- 560043
Bangalore
KARNATAKA |
080-25459599
prateeknayak@yahoo.com |
| DrChandrashekaran |
Public Health Centre |
Department of ENT,174 lake view Road, West Mambalam,Chennai- 600033
Chennai
TAMIL NADU |
044-28275832
schan2004@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| ACE Ethics committe for pace clinical research centre |
Approved |
| ACE Ethics committee - Gowri Prassana Diabets & Heartcare centre |
Approved |
| Institutional Ethics Commitee, Grant Medical College |
Approved |
| League Health Independent Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Male and female subjects of 18 years and above with allergic rhinitis , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
FDC of Montelukast 10mg + Levocetirizine 5 mg tablet |
FDC of Montelukast 10mg + Levocetirizine 5 mg tablet - One tablet daily for 14 days |
| Intervention |
montelukast and fexofenadine fixed dose combination |
FDC of Montelukast 10mg + Fexofenadine 120 mg tablet - One tablet daily for 14 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Males and females patients more than 18 years of age.
2.Patients with diagnosis of Allergic Rhinitis (patients with a total nasal symptom score (TNSS; the sum of all the 4 individual nasal symptom scores) of 6 or greater and/or a total ocular symptom score (TOSS; the sum of all the 3 individual ocular symptom scores) of 4 or greater.)
3.Except Allergic Rhinitis, patients must be in general good health based on screening.
4.Patients having bronchial symptoms along with Allergic Rhinitis are also allowed to participate in the study.
5.Patients must give written informed consent after reading the Patient Information sheet and Informed Consent Form and having had the opportunity to discuss the study with the Investigator.
6.Patient willing to follow up and comply with the Protocol requirements
|
|
| ExclusionCriteria |
| Details |
1.Males and females patients less than 18 years of age.
2.Pregnant and lactating women patients.
3.Patients not willing to comply with the study protocol and provide written informed consent to participate.
4.Patient with severe asthma requiring emergency room treatment within 1 month or hospitalization within 3 month before the trial.
5.Patients with upper respiratory tract infection or acute or chronic pulmonary disorder.
6.Patients with known hypersensitivity to Montelukast or Fexofenadine or other piperazine derivatives.
7.Expected use of any other medications for allergic rhinitis or conjunctivitis during the treatment period e.g. antihistamines, corticosteroids (inhaled, oral, parenteral, nasal and ophthalmic), cromolyn sodium, nedocromil and inhaled cholinergics.
8.Medications that could affect nasal or ocular symptoms including decongestants and anti-inflammatory drugs are not permitted.
9.No allergic rhinitis rescue medications are permitted during the study.
10.Patient not willing to participate in the trial
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • The change in Total Symptom Score [(TSS is the sum Total nasal symptom score (TNSS) and Total Ocular symptom score (TOSS)] at the end of study as compared to baseline |
baseline, Day 7 and Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Total nasal symptom score (TNSS) (nasal congestion, rhinorrhea, nasal itching, and sneezing) at the end of study as compared to baseline |
Baseline, Day 7 and Day 14 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/06/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
study will be published in national journals |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is an randomized, open label, prospective, two arm, comparative multicentric study to evaluate the efficacy and safety of montelukast and fexofenadine fixed dose combination vs montelukast and levocetirizine fixed dose combination in the management of patients with allergic rhinitis.
Primary Endpoints
- The change in Total Symptom Score [(TSS is the sum Total nasal symptom score (TNSS) and Total Ocular symptom score (TOSS)] at the end of study as compared to baseline.
Secondary Endpoints
- Total nasal symptom score (TNSS) (nasal congestion, rhinorrhea, nasal itching, and sneezing) at the end of study as compared to baseline
- Total Ocular symptom score (TOSS) (Itching/burning eyes, tearing/watering eyes and eye redness) at the end of study as compared to baseline
- Physician’s and Patient’s Global assessment for efficacy and tolerability
- To evaluate the safety by assessing the type, number, frequency and proportion of patients with Adverse Event(s) during the study.
Total nasal symptom score (TNSS) and Total Ocular symptom score (TOSS) will be graded on 4-point categoric scale:
0 = none/ no symptoms;
1 = mild symptoms, but not affecting any activities during the day/sleep at night;
2 = moderate symptoms affecting at least one activity or disturbing sleep;
3 = severe symptoms affecting >2 daily activities or disturbing sleep all night or most of the night
|