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.

Phase 3

Not yet recruiting

• Conditions: Allergic rhinitis, unspecified,

• Registration Number: CTRI/2022/03/040760
• Lead Sponsor: Akums Drugs Pharmaceuticals Limited

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-02-03
• Study Start: 2022-03-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• 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.
• Subjects with total IgE level ≥75kU/L will be included.
• 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.
• 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.
• 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.
• Subjects shall be in good health and free from any clinically significant disease, other than allergic rhinitis, that might interfere with the study evaluations.
• Subjects willing to refrain from use of all other anti-allergic medications during the 14-day treatment period.

Exclusion Criteria

• 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.
• 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.
• 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.
• Subjects with congestive heart failure, liver diseases, such as cirrhosis or chronic active hepatitis or cerebrovascular disorder within 3 months before informed consent.
• Subjects with abnormal Liver Function Test with values more than 2.5 times the upper limit of normal.
• Subjects with known case of Oncological Conditions.
• Subjects with history of infection with HIV, Hepatitis B virus or Hepatitis C virus.
• Subject with any clinically significant laboratory abnormalities at screening visit.
• Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation.
• Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results.
• Subjects having any condition that would compromise compliance with this protocol.
• Subjects who have been treated with an investigational drug or investigational device within a period of 4 weeks prior to study entry.
• Currently taking prohibited concomitant medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
• Suspected inability or unwillingness to comply with the study procedures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in daytime nasal symptom score, defined as mean of scores of four	Baseline, Visit 3, Visit 4(End of study)
daytime nasal symptoms (congestion, rhinorrhea, pruritus, and sneezing, baseline to end of study	Baseline, Visit 3, Visit 4(End of study)
.	Baseline, Visit 3, Visit 4(End of study)

Secondary Outcome Measures

Name	Time	Method
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
Mean change in nighttime nasal symptom score, defined as mean of scores of three	nighttime nasal symptoms (difficulty going to sleep, nighttime awakenings, and
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).
Mean change in composite nasal symptom score (mean of daytime nasal and	nighttime nasal symptoms scores), from baseline to end of study.

Trial Locations

Locations (10)

AIIMS, Raipur; 🇮🇳 Raipur, CHHATTISGARH, India

College of Medicine & JNM Hospital,; 🇮🇳 Nadia, WEST BENGAL, India

ENT and GYNAE CENTRE; 🇮🇳 West, DELHI, India

GCS Medical College, Hospital and Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

Government of Medical College and Government General Hospital; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

GSVM Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

Kanoria Hospital and Research Centre; 🇮🇳 Gandhinagar, GUJARAT, India

Mandya Institute Of Medical Sciences; 🇮🇳 Mandya, KARNATAKA, India

Rajalakshmi Hospital & Research Center; 🇮🇳 Bangalore, KARNATAKA, India

Vignesh Fertility and Children’s Hospital; 🇮🇳 Krishna, ANDHRA PRADESH, India

AIIMS, Raipur

🇮🇳Raipur, CHHATTISGARH, India

Dr Atul Jindal

Principal investigator

8224014667

dratuljindal@gmail.com