| CTRI Number |
CTRI/2014/02/004439 [Registered on: 28/02/2014] Trial Registered Retrospectively |
| Last Modified On: |
30/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A clinical study to evaluate efficacy & safety of a novel nasal spray fixed dose combination of Azelastine hydrochloride & Mometasone furoate monohydrate compared with individual Azelastine hydrochloride 137mcg & Mometasone Monohydrate 50mcg nasal spray in patients with perennial Allergic Rhinitis. |
|
Scientific Title of Study
|
A randomized, single blind, comparative, three way crossover clinical study
to evaluate the efficacy and safety of a novel nasal spray (FDC of Azelastine hydrochloride and Mometasone furoate
monohydrate) compared to its individual components Azelastine
hydrochloride 137 mcg and Mometasone furoate monohydrate 50 mcg
nasal sprays in patients suffering from perennial Allergic Rhinitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CP/03/12, Ver. No.03, 6-09-2013; Amnd 1, 28-11-2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sundeep Salvi |
| Designation |
Director |
| Affiliation |
Chest Research Foundation |
| Address |
Chest Research Foundation, Marigold Premises, Survey No.15, Vadgaon Sheri, Kalyani Nagar, Pune
Pune
MAHARASHTRA
411014
India |
| Phone |
09921211000 |
| Fax |
|
| Email |
ssalvi@crfindia.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaideep Gogtay |
| Designation |
Chief Medical Officer |
| Affiliation |
Cipla Ltd. |
| Address |
Cipla Ltd., Bellasis Road, Mumbai Central, Mumbai
Mumbai
MAHARASHTRA
400 008
India |
| Phone |
02223025412 |
| Fax |
02225787855 |
| Email |
jgogtay@cipla.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Abhijit Vaidya |
| Designation |
Sponsor’s Project Manager |
| Affiliation |
Cipla Ltd. |
| Address |
Cipla Ltd., 3rd Floor, Raj Plaza, LBS Marg, Vikhroli (West)
Mumbai
MAHARASHTRA
400083
India |
| Phone |
02225716085 |
| Fax |
02225787855 |
| Email |
abhijit.vaidya@cipla.com |
|
|
Source of Monetary or Material Support
|
| Cipla Ltd., Bellasis Road, Mumbai Central, Mumbai, Phone 02223082891 Fax 02225787855 |
|
|
Primary Sponsor
|
| Name |
Cipla Ltd |
| Address |
Bellasis Road, Mumbai Central, Mumbai, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Atul Kansara |
AMC MET Medical college & Sheth LG General Hospital |
ENT Department, AMC MET Medical college & Sheth LG General Hospital, ENT Department, Rambaug, Maninager, Ahmedabad-380008
Ahmadabad
GUJARAT |
9825034050
-
dratulkansara@sify.com |
| Dr Sundeep Salvi |
Chest Research Foundation |
Respiratory Medicine Department, Chest Research Foundation,
Marigold Premises, Survey No.15,Vadgaon Sheri, Kalyani Nagar, Pune – 411014.
Pune
MAHARASHTRA |
9921211000
-
ssalvi@crfindia.com |
| Dr Sanjiv Walanj |
Ethika Clinical Research Center |
Respiratory Medicine Department, Ethika Clinical Research Center, Siddeshwar Arcade, first floor, opp. Manisha Nagar, gate no.1, Kalwa, Thane (w)- 400605
Thane
MAHARASHTRA |
9892721857
-
sanjiv_walanj@yahoo.com |
| Dr Anand Patel |
GMERS Medical college and General Hospital |
Dept. of Respiratory Medicine, GMERS Medical college and General Hospital, Gotri, Vadodara- 390021
Vadodara
GUJARAT |
9879771079
-
dranandkpatel@gmail.com |
| Dr G Shyam |
Mahavir Hospital Research Centre |
ENT Department, Mahavir Hospital Research Centre, H. No. 10-1-1, Mahavir Marg, A. C. Gaurds, Hyderabad–500004
Hyderabad
ANDHRA PRADESH |
9849027970
-
shyamvishwa@yahoo.com |
| Dr Nandu Kolwadkar |
Orange City Hospital & Research Institute |
ENT Department, Orange City Hospital & Research Institute, 19, Pandey Layout, Veer
Sawarkar Square, Nagpur-440015
Nagpur
MAHARASHTRA |
9822396797
-
nandu44@gmail.com |
| Dr Naveen Kumar AG |
Saptagiri Hospital |
ENT Department, #15, Saptagiri Hospital,
Chikkasandra, Hesaraghatta Main Raod, Bangalore–560027
Bangalore
KARNATAKA |
07259483563
-
agnaveen27@yahoo.com |
| Dr Akash Balki |
Shree Hospital and Critical Care Centre |
Shree Hospital and Critical Care Centre,
799, Om Nagar, Mirchibazar
Sakkardara Square,
Nagpur - 440009
Nagpur
MAHARASHTRA |
9890812215
-
akash_balki@yahoo.com |
| Dr Ranjan Aiyer |
Sir Sayajirao General hospital |
ENT Department,Ward No.19, OPD No.15., Sir Sayajirao General hospital,
Jail Road, Vadodara – 390001
Vadodara
GUJARAT |
9825184648
-
drrgaiyer@hotmail.com |
| Dr Mohnish Grover |
SMS Medical College and Hospital |
ENT Department, SMS Medical College and Hospital, JNL Marg, Jaipur – 302004.
Jaipur
RAJASTHAN |
09461306200
-
drmohnish_aiims@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethical Committee Chest Research Foundation, Pune- Dr. Sundeep Salvi |
Approved |
| Ethics Committee –Bhatia Hospital Medical Research Society, Mumbai for Ethika Clinical Research Center-Dr. Sanjiv Walanj |
Approved |
| Ethics Committee, Bhagwan Mahavir Medical Research Center For Biomedical Research, Hyderabad-Dr. G. Shyam |
Approved |
| Institutional Human Ethics Committee (Institutional Review Board) GMERS Medical College Vadodara-Dr Anand Patel |
Approved |
| Orange City Hospital Institutional Ethics Committee, Nagpur- Dr. Nandu Kolwadkar |
Approved |
| Sapthagiri Institute Of Medical Sciences and Research Center, Banglore- Dr Naveen Kumar AG |
Approved |
| Shree Hospital Ethics Committee for Dr. Akash Balki-Nagpur |
Approved |
| The Ethics Committee, S.M.S. Medical College and Attached Hospitals, Jaipur- Dr. Mohnish Grover |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients suffering from Perennial allergic Rhinitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Azelastine hydrochloride 137 mcg |
Nasal spray-Manufactured by MEDA Pharmaceuticals Inc., US.
One spray per nostril twice daily for 2 weeks |
| Intervention |
Azelastine Hydrochloride 137 mcg and Mometasone Furoate Monohydrate 50 mcg |
A novel nasal spray-Fixed dose combination. Manufactured
by Cipla Pharmaceuticals Limited, India.
One spray per nostril twice daily for 2 weeks |
| Comparator Agent |
Mometasone furoate monohydrate 50 mcg |
Nasal spray-Manufactured by Schering Plough,US.
One spray per nostril twice daily for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. An Ethics committee approved Informed Consent Form signed and
dated by subject and or LAR before screening procedures.
2. Subjects of either sexes between 18 and 55 years of age with at least
1 positive response to air allergen in skin prick test at screening and a
history of perennial allergic rhinitis.
3. Subjects presenting with moderate to severe symptoms of perennial
allergic rhinitis (nasal and/or ocular)
4. In the opinion of the investigator, subject able to comply with
requirements of Protocol. |
|
| ExclusionCriteria |
| Details |
1. Subjects with history of severe physical nasal obstruction or injury,
nasal ulcers, nasal polyps, significant deviated nasal septum, recent
nasal surgery, asthma, COPD, rhinitis medicamentosa, acute or
chronic sinusitis, glaucoma, cataract, any psychiatric disorder,
adrenal insufficiency and contact lens wearers.
2. Subjects with bacterial, viral or fungal infection within 2 weeks prior to
screening visit.
3. Subjects with known hypersensitivity to all study medicines
4. Subjects with history of alcohol or drug abuse
5. Subjects who have participated in clinical trial in past 30 days
6. Pregnant or lactating mothers or planning to become pregnant
7. Any clinically significant lab values as per investigators discretion
8. Subjects suffering from significant uncontrolled disease of any body
system
9. Use of anti-allergic immunotherapy or biologicals within past 2 years |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in 12 hour reflective total nasal symptom score (rTNSS) and Change in 12 hour reflective total ocular symptom score (rTOSS) for active treatments. |
At 7th and 14th day of treatment from baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Maximum PNIF response to nasal AMP challenge for active
treatments (In 10 percent subjects at Chest Research Foundation) |
After 14th day from baseline |
| Onset of action (based on instantaneous scores iTNSS and iTOSS) |
On the day of 1st dose of each treatment for 12 hours from dosing |
| Difference in number of rescue medication tablets required |
After 14 days treatment from baseline |
| Adverse events (both drug related and unrelated) |
Throughout the study |
| Overall tolerability of subject to study medicine |
Throughout the study |
Clinically significant changes in laboratory values, vital signs, physical
examination |
Throughout the study |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/02/2014 |
| Date of Study Completion (India) |
28/07/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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
|
This is a randomized, single blind, comparative, three way crossover clinical study to evaluate the efficacy and safety of Fixed Dose Combination Azelastine Hydrochloride and Mometasone Furoate Monohydrate (Manufactured by Cipla Ltd.) comparing with its individual components Azelastine 137mcg and Mometasone furoate 50 mcg nasal spray in patients suffering from perennial allergic rhinitis.
Total 120 patients will be enrolled in to the study from at least 9 participating centers in india. All the patients will be given 3 treatements of 2 weeks each with 2 weeks washout period. All treatments will be administered as one spray per nostril twice daily. Loratidine 10mg tablet will be given as a rescue medication throughout the study for use, as and when required, to a maximum once daily dose.
Primary outcome measures will be the change in reflective total nasal symptom score and change in reflective total ocular symptom score for active treatments with onset of action, difference in number of rescue medication required. 10 percent subjects of the sample size will be evaluated for maximum PNIF response to nasal AMP challenge for active treatments at one of the site. Safety endpoints will be Adverse events, overall tolerability of subject to study medicine, and clinically significat changes in laboratory values, vital signs, physical examination.
|