A clinical trial to test the effectiveness of 2 drugs, a combination product {Ebastine (anti-histaminic or cold medication) plus Montelukast (anti-allergic medication)} in comparison with Ebastine (anti-histaminic or cold medication) in the treatment of patients with allergic rhinitis.
- Conditions
- Allergic Rhinitis classified according to the International guidelines of ARIA
- Registration Number
- CTRI/2013/07/003797
- Lead Sponsor
- Micro Labs Limited
- Brief Summary
This clinical trial is a phase 3, randomised, parallel group, active controlled trial comparing the clinical efficacy, & safety profile of a fixed dose combination i.e. Ebastine with Montelukast versus Ebastine in patients with Allergic Rhinitis.
The study duration is expected to be of 6 weeks, with 1 week follow up after the study.
The clinical efficacy will be tested by the following parameters
- Total Symptom Score
- Physician evaluation of signs of allergic rhinitis
- Rhinoconjuctivitis Quality of Life scale
- Comparing sedation between two groups using VAS
The safety of the drug(s) during the study will be monitored by adverse effect monitoring during patient visits or through telephonic information in between visits, & laboratory investigations.
The compliance will also be monitored by pill-counting the left over medication during patient visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 552
- Males and females of 12 – 65 years (inclusive) 2.
- Diagnosis of mild and moderate-severe persistent allergic rhinitis ( ≥ 4 days per week AND ≥ 4 weeks) 3.
- Able to provide informed consent to participate in the study (If minor [<18 years, consent from parent/legally authorized representative must also to be obtained in addition to the consent from the patient) 4.
- Ability to understand study procedures and to comply with them for the entire length of the study including able to record symptom scores in a diary (literate patients).
- TSS baseline score of at least 5 after mean of 3 scores (based on investigator assessment) 6.
- Treatment naive for current episode of allergic rhinitis [If patient has already consumed more than 3 days’ doses of oral antihistamines for the current episode, then a wash-out of about 6-7 days to be given before administering study medication based on investigator discretion and patient willingness; if the patient consumes 1-2 doses of OTC cold medications for symptomatic relief, washout is not given.].
- Asthma patients 2.
- Subjects with a current history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
- Subjects who, in the opinion of the investigator, are dependent on nasal, oral or ocular decongestants, nasal topical antihistamines or nasal steroids.
- Any illness requiring steroid by any route.
- Urticaria, Vasomotor rhinitis, Rhinitis medicamentosa.
- Subjects who have, in the opinion of the investigator or designee, clinically significant nasal structural abnormalities, including large nasal polyps or marked septum deviation, that significantly interferes with nasal air flow.
- Pregnancy or lactation.
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- Use of any other investigational drug in the last 90 days.
- Subjects known to have an idiosyncratic reaction to any of the ingredients in IMP.
- Subject with clinically significant abnormal vital sign or laboratory value that precludes participation.
- Subjects with current evidence of clinically significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disease, or other disease that preclude the subjects participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Objective: 2 weeks To compare the efficacy of Ebastine 10 mg plus Montelukast 10 mg with Ebastine 10 mg in decreasing the symptoms of allergic rhinitis for the first two weeks 2 weeks Primary efficacy endpoint: 2 weeks Change from baseline in the Total Symptom Score to the end of first two weeks of treatment 2 weeks
- Secondary Outcome Measures
Name Time Method Secondary Objective: To compare safety of Ebastine 10 mg plus Montelukast 10 mg with Ebastine 10 mg when used for treatment of allergic rhinitis for 6 wks
Trial Locations
- Locations (12)
BYL Nair Hospital
🇮🇳(Suburban), MAHARASHTRA, India
Calcutta National Medical College
🇮🇳Kolkata, WEST BENGAL, India
Dr. B.R Ambedkar Medical College
🇮🇳Bangalore, KARNATAKA, India
Grant Government Medical College & Sir JJ group of Hospitals
🇮🇳Mumbai, MAHARASHTRA, India
Grant Medical College & Sir J.J.Group of Hospitals
🇮🇳(Suburban), MAHARASHTRA, India
Kempegowda Institute of Medical Sciences
🇮🇳Bangalore, KARNATAKA, India
Lady Hardinge Medical College
🇮🇳Delhi, DELHI, India
Medica Superspeciality Hospital
🇮🇳Kolkata, WEST BENGAL, India
Medical College and Hospital, Kolkata
🇮🇳Kolkata, WEST BENGAL, India
National Allergy Asthma Bronchitis Institute
🇮🇳Kolkata, WEST BENGAL, India
Scroll for more (2 remaining)BYL Nair Hospital🇮🇳(Suburban), MAHARASHTRA, IndiaDr Bachi HathiramPrincipal investigator09004051418orlclinics@gmail.com