A clinical trial to study the effects of two drugs, fexofenadine and montelukast in the treatment of persistent allergic rhinitis

Phase 3

• Conditions: allergic rhinitis

• Registration Number: CTRI/2010/091/000517
• Lead Sponsor: M/S. Theon Pharmaceuticals Ltd.

Brief Summary

This study is a randomized, open label, parallel group, multi centre trial comparing the safety efficacy of Fexofenadine 120mg and Montelukast 10 mg daily for 2 months in 200 patients with allergic rhinitis that will be conducted in four centres in India

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

Subjects in the age group of 18-75 years (age of assent)Written and/or witnessed informed consent to participate in the trial was taken prior to initiating the study from the parent and/ or the legally accepted representative.Patients who had at least 6 months previous history of confirmed diagnosis of allergic rhinitisA positive skin-prick test response to at least 1 of 8 allergens [house dust, grass pollens, tree pollens, ragweeds, seasonal allergens, cat fur, cockroach and strong odors]Clinically symptomatic at Screening and at the Baseline VisitsPatients with nasal congestion score of at least 2 using a 4-point scale (0 = none, 3 = severe)Freedom from any clinically significant disease, other than SAR, that would interfere with the study evaluationsPatients who did not receive either of the study medication Women with negative pregnancy test on the randomization dayWomen in childbearing age group agreed to use appropriate contraception during the trial.

Exclusion Criteria

Patients known, or thought to be hypersensitivity to study drugsPatients having had upper respiratory tract infection during the 6-week period preceding the study Patients with septal deviation, nasal polyps, acute or chronic rhinosinusitisPatients with any other condition that might affect nasal breathing or nocturnal sleep patternHistory of nasal reconstructive surgery Patients with abnormal liver and kidney function History of asthma or asthmatic bronchitisElectrocardiographic abnormalities including conduction delay and an abnormal QTc intervalHistory of auto-immune disease History of chronic lung disease Excluded medications were astemizole within 3 months; oral or parenteral corticosteroids within 1 month; cromolyn, nedocromil, or nasal or ophthalmic corticosteroids within 2 weeks; cetirizine, zilenton, zafirlukast, oral or long-acting inhaled 13-adrenergic agonists or inhaled anticholinergic agents within 1 week; terfenadine, loratadine, or fexofenadine within 72 hours; and short-acting antihistamines and decongestants within 24 hours before visitConcurrent use of antibiotics, antivirals, nasal steroids, decongestants or antihistamines Any medication or indication that might point to an increased risk, associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the study personnel, would make the subject inappropriate for inclusion Participation in other clinical trials the last three months and during study participation.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this trial is to evaluate any difference between oral tablets of the fixed-dose combination of montelukast 10 mg and fexofenadine 120 mg with Allegra oral tablets, which is Fexofenadine hydrochloride 120 mg alone in treatment of persistent allergic rhinitis in terms of efficacy by virtue of symptomatic improvement during the ten-day study duration.	10 days

Secondary Outcome Measures

Name	Time	Method
The secondary objective of this trial is to evaluate any difference between oral tablets of the fixed-dose combination of montelukast 10 mg and fexofenadine 120 mg with Allegra oral tablets, which is Fexofenadine hydrochloride 120 mg alone in treatment of persistent allergic rhinitis in terms of safety by virtue of comparing adverse events in each arm throughout the trial duration and clinical chemistry profiles at the baseline and end-of-study.	end of study

Trial Locations

Locations (4)

Clinic, Bhavnagar, Rajivoza59@hotmail.com; 🇮🇳 Bhavnagar, GUJARAT, India

K E M Hospital, Mumbai, pkitic@yahoo.in; 🇮🇳 Mumbai, MAHARASHTRA, India

N H L Muni. Medical College & Hospital, Ahmedabad, Rajpurvi@yahoo.com; 🇮🇳 Ahmadabad, GUJARAT, India

R N Cooper Hospital, Mumbai, nitinmr@yahoo.in; 🇮🇳 Mumbai, MAHARASHTRA, India

Clinic, Bhavnagar, Rajivoza59@hotmail.com

🇮🇳Bhavnagar, GUJARAT, India

Dr. Rajiv R Oza

Principal investigator

Rajivoza59@hotmail.com