CTRI/2022/03/040760 [Registered on: 03/03/2022] Trial Registered Prospectively
Last Modified On:
02/03/2022
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 Clinical study of Fixed Dose Combination of Bilastine 10 mg plus Montelukast 4 mg orodispersible Tablets compared with Bilastine 10 mg orodispersible Tablet and Montelukast 4 mg orodispersible Tablet monotherapy for the Treatment of Allergic Rhinitis.
Scientific Title of Study
A Multicenter, Randomized, Double-Blind, Active Controlled,Parallel-Group, Comparative,Phase III Clinical Study to Evaluate the Efficacy and Safety of FDC of Bilastine 10 mg plus Montelukast 4 mg orodispersible Tablets versus Bilastine 10 mg orodispersible
Tablet and Montelukast 4 mg orodispersible Tablet monotherapy for the Treatment of Allergic Rhinitis.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
BRPL/CT/FDC/BIM/12/20; Version 2.0; Date: 17.03.2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Aditi Datta
Designation
Managing Director
Affiliation
Biosite Research Private Limited
Address
Office No 81, 82, 83 & 84 3rd Floor Chandru Complex, 18th Main RBI Layout, JP Nagar Phase 7
Bangalore KARNATAKA 560061 India
Phone
091-9811788955
Fax
Email
aditi.datta@biositeindia.com
Details of Contact Person Scientific Query
Name
Dr Aditi Datta
Designation
Managing Director
Affiliation
Biosite Research Private Limited
Address
Office No 81, 82, 83 & 84 3rd Floor Chandru Complex, 18th Main RBI Layout, JP Nagar Phase 7
KARNATAKA 560061 India
Phone
091-9811788955
Fax
Email
aditi.datta@biositeindia.com
Details of Contact Person Public Query
Name
Dr Aditi Datta
Designation
Managing Director
Affiliation
Biosite Research Private Limited
Address
Office No 81, 82, 83 & 84 3rd Floor Chandru Complex, 18th Main RBI Layout, JP Nagar Phase 7
Plot No. 131 to 133, Block –C, Mangolpuri Industrial
Area, Phase -1 (Adjoining CBSE Office), New Delhi - 110083.
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 10
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Atul Jindal
AIIMS, Raipur
Department of Paediatric Medicine, Room No. 1111, First Floor, Medical college complex, Gate no.05, AIIMS G.E. Road Tatibandh Raipur-492099, Chhattisgarh Raipur CHHATTISGARH
8224014667
dratuljindal@gmail.com
Dr Indranil Halder
College of Medicine & JNM Hospital,
Department of Pulmonary Medicine, College of Medicine & JNM Hospital, Kalyani, Nadia 741235 Nadia WEST BENGAL
9830383102
indranilh@yahoo.com
Dr Deepak Gupta
ENT and GYNAE CENTRE
ENT and GYNAE CENTRE, Department of ENT, 126/106, Najafgarh Road, Nangloi, Opposite Sankalp Hospital, New Delhi-110029. West DELHI
9810378832
drdeepakgupta@rediffmail.com
Dr Suktara Arvind Sharma
GCS Medical College, Hospital and Research Centre
Department of ENT, GCS Medical College, Hospital and Research Centre Nr. Chamunda Bridge, Naroda Road, Ahmedabad-380025 Ahmadabad GUJARAT
9409286294
suktarasharma@yahoo.co.in
Dr A Gopal Rao
Government of Medical College and Government General Hospital
Department of END, Government of Medical College and Government General Hospital, Srikakulam - 532001 Srikakulam ANDHRA PRADESH
8942279033
drgopalraoa@gmail.com
Dr Rupa Singh
GSVM Medical College
Department of paediatrics, GSVM Medical College, Swaroop Nagar, Kanpur-208002 Kanpur Nagar UTTAR PRADESH
9935060778
drrupa9@gmail.com
Dr Bhaumik Pate
Kanoria Hospital and Research Centre
Kanoria Hospital and Research centre, Department of ENT, Airport- Gandhinagar Highway, Village Bhat, Dist- Gandhinagar, 382428 Gandhinagar GUJARAT
9724123026
dr.bhaumikpatel@gmail.com
Dr Hanumanth Prasad M
Mandya Institute Of Medical Sciences
Department of ENT, Mandya Institute Of Medical Sciences, Bangalore-Mysore Road, Mandya, Karnataka-571401 Mandya KARNATAKA
9916856058
drmhp@yahoo.com
Dr Nagaraja M V
Rajalakshmi Hospital & Research Center
Rajalakshmi Hospital & Research Center, Department of ENT, 21/1,Lakshmipura Main Road, Vidyaranyapura Post, Bangalore-560097
Bangalore KARNATAKA
9620810799
drnagarajmv@gmail.com
Dr A Srimukhi
Vignesh Fertility and Children’s Hospital
Vignesh Fertility and Children’s Hospital, Department of ENT, Sikhamani center, Prajashkti Nagar,Vijayawada-520002 Krishna ANDHRA PRADESH
7799867867
dr.srimukhianumolu@gmail.com
Details of Ethics Committee
No of Ethics Committees= 10
Name of Committee
Approval Status
Ethics Committee GSVM Medical College
Submittted/Under Review
Institution Ethics Committee AIIMS Raipur
Submittted/Under Review
Institution Ethics Committee of College of Medicine & JNM Hospital
Submittted/Under Review
Institutional Ethics Committee Anu Hospitals
Approved
Institutional Ethics Committee GCS Medical College, Hospital and Research Centre
Submittted/Under Review
Institutional Ethics Committee Mandya Institute of Medical Sciences
Submittted/Under Review
Institutional Ethics Committee Rajalakshmi Hospital & Research Center
Approved
Institutional Ethics Committee, Government of Medical College and Government General Hospital
Approved
Kanoria Ethics Committee, Kanoria Hospital and Research Centre
One orodispersible tablet once daily, at bedtime, for the duration of 14 days.
Intervention
FDC of Bilastine 10 mg plus Montelukast Sodium IP
Eq. Montelukast 4 mg orodispersible Tablets
One orodispersible tablet once daily, at bedtime, for the duration of 14 days.
Comparator Agent
Montelukast 4 mg orodispersible Tablets
One orodispersible tablet once daily, at bedtime, for the duration of 14 days.
Inclusion Criteria
Age From
6.00 Year(s)
Age To
12.00 Year(s)
Gender
Both
Details
1. Male and female subjects between 6 to 12 years of age (both inclusive).
2.Subjects with symptoms of allergic rhinitis characterized by nasal congestion, rhinorrhoea, pruritus and sneezing.
3. Subjects with total IgE level ≥75kU/L will be included.
4. Subjects having at least mild-to-moderate daytime nasal symptoms (namely, a minimum predefined 3-day cumulative score of 18 on the subject diary) before randomization.
5. Subjects who voluntarily give, IEC/IRB approved, signed written informed assent form and, the parent or legal guardian give signed informed consent form, as appropriate, to participate in this clinical investigation.
6. Subjects, and the parent or legal guardian, shall be willing and able to understand
and comply with the requirements of the study, administer the medication as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
7. Subjects shall be in good health and free from any clinically significant disease, other than allergic rhinitis, that might interfere with the study evaluations.
8. Subjects willing to refrain from use of all other anti-allergic medications during the
14-day treatment period.
ExclusionCriteria
Details
1. Subjects with upper respiratory tract infections within 4 weeks prior to study entry.
2.Subjects with rhinitis related to anatomic problems (nasal polyps, large adenoids,significant deviation of the nasal septum, any injury or tumor in the nose etc).
3.Subjects with nasal surgery within 3 months prior to study entry.
4. Subjects with severe physical nasal obstruction or injury, nasal ulcers, asthma, rhinitis medicamentosa, congestive rhinitis, atrophic rhinitis, acute or chronic sinusitis, sinusitis with purulent nasal discharge, glaucoma, cataract, any psychiatric disorder, and bacterial or viral infection within 2 weeks of participation
in the study.
5. Subjects receiving astemizole within 3 months; oral or parenteral corticosteroids within 1 month; nasal or ophthalmic corticosteroids within 2 weeks; cetirizine, zafirlukast, oral or long-acting inhaled β-adrenergic agonists or inhaled anticholinergic agents within 1 week; terfenadine, loratadine, or fexofenadine
within 72 hours; oral or topical H1-receptor antagonists within 48 hrs; and short-acting antihistamines and decongestants within 24 hours prior to screening.
6.Subjects receiving antipruritic agents, NSAIDs and cold remedies within 3 days prior to the study entry.
7. Subjects with congestive heart failure, liver diseases, such as cirrhosis or chronic active hepatitis or cerebrovascular disorder within 3 months before informed consent.
8. Subjects with abnormal Liver Function Test with values more than 2.5 times the upper limit of normal.
9. Subjects with known case of Oncological Conditions.
10. Subjects with history of infection with HIV, Hepatitis B virus or Hepatitis C virus.
11. Subject with any clinically significant laboratory abnormalities at screening visit.
12. Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
13. Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results.
14. Subjects having any condition that would compromise compliance with this protocol.
15. Subjects who have been treated with an investigational drug or investigational
device within a period of 4 weeks prior to study entry.
16. Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
17. Suspected inability or unwillingness to comply with the study procedures.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Mean change in daytime nasal symptom score, defined as mean of scores of four
daytime nasal symptoms (congestion, rhinorrhea, pruritus, and sneezing, baseline to end of study
.
Baseline, Visit 3, Visit 4(End of study)
Secondary Outcome
Outcome
TimePoints
Mean change in nighttime nasal symptom score, defined as mean of scores of three
nighttime nasal symptoms (difficulty going to sleep, nighttime awakenings, and
nasal congestion on awakening), from baseline to end of study.
At Day 1, Day 7 & Day 14 (End of Study).
Mean change in daytime eye symptoms score, defined as mean of scores of four
daytime eye symptoms (tearing, pruritus, redness, and puffiness), from baseline to
end of study.
At Day 1, Day 7 & Day 14 (End of Study).
Mean change in composite nasal symptom score (mean of daytime nasal and
nighttime nasal symptoms scores), from baseline to end of study.
At Day 1, Day 7 & Day 14 (End of Study).
Mean change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores from baseline to end of study.
At Day 1, Day 7 & Day 14 (End of Study).
Target Sample Size
Total Sample Size="330" Sample Size from India="330" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
25/03/2022
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
NIL
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy and Safety of FDC of Bilastine 10 mg plus Montelukast 4 mg orodispersible Tablets versus Bilastine 10 mg orodispersible Tablet and Montelukast 4 mg orodispersible Tablet monotherapy for the Treatment of Allergic Rhinitis in Male and female subjects between 6 to 12 years of age (both inclusive).
There will be 4 Visits during the entire Clinical Trial {Visit 1: Screening Visit (Day -3 to Day 1); Visit 2: Randomization/Baseline Visit (Day 1); Visit 3: Interim Visit (Week 1/Day 7 ± 2 days) ; Visit 4: End of Study/Early Termination Visit (Week 2/Day 14 ± 2 days)}.
After informed assent and consent process, completion of all screening assessments and once all the inclusion/exclusion criteria are met, the eligible subjects shall be enrolled into the study. At randomization/baseline visit, subjects shall be randomly (Double-blind) assigned in a 1:1:1 fashion to one of the three treatment groups. Subjects shall administer one orodispersible tablet once daily, at bedtime, for the duration of 14 days. The tablet should not be crushed chewed or swallowed, but it should be kept in the oral cavity, allowing it to disperse and disintegrate in the oral cavity to leave an easy-to-swallow residue.
Study drugs shall be dispensed by the independent dispenser or designated personnel at the investigative site who shall not participate in any other activity pertaining to the subject’s safety and efficacy assessment that may impact the study outcome. Subjects shall administer one orodispersible tablet once daily, at bedtime, for the duration of 14 days.
Laboratory investigations and Urine examination (Routine & Microscopic) shall be performed during the screening visit and week 2/end of the study visit. Serum IgE test shall be performed during screening visit and week 2/end of study visit. 12 Lead ECG shall be performed during screening visit and week 2/end of study visit. Nasal endoscopy shall be performed during the screening visit. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) assessment shall be performed during screening visit and week 2/end of study visit.
A subject diary shall be provided to the subjects to record administration of the study medication, Nasal and non-nasal symptoms, concomitant medication details and adverse events if any. All subjects shall be instructed to complete the subject diary after each administration.