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.
- Conditions
- Patients suffering from Perennial allergic Rhinitis
- Registration Number
- CTRI/2014/02/004439
- Lead Sponsor
- Cipla Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
- An Ethics committee approved Informed Consent Form signed and dated by subject and or LAR before screening procedures.
- 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.
- 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.
- 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.
- Subjects with bacterial, viral or fungal infection within 2 weeks prior to screening visit.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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 Overall tolerability of subject to study medicine Throughout the study Adverse events (both drug related and unrelated) Throughout the study Maximum PNIF response to nasal AMP challenge for active treatments (In 10 percent subjects at Chest Research Foundation) Clinically significant changes in laboratory values, vital signs, physical examination
Trial Locations
- Locations (10)
AMC MET Medical college & Sheth LG General Hospital
🇮🇳Ahmadabad, GUJARAT, India
Chest Research Foundation
🇮🇳Pune, MAHARASHTRA, India
Ethika Clinical Research Center
🇮🇳Thane, MAHARASHTRA, India
GMERS Medical college and General Hospital
🇮🇳Vadodara, GUJARAT, India
Mahavir Hospital Research Centre
🇮🇳Hyderabad, ANDHRA PRADESH, India
Orange City Hospital & Research Institute
🇮🇳Nagpur, MAHARASHTRA, India
Saptagiri Hospital
🇮🇳Bangalore, KARNATAKA, India
Shree Hospital and Critical Care Centre
🇮🇳Nagpur, MAHARASHTRA, India
Sir Sayajirao General hospital
🇮🇳Vadodara, GUJARAT, India
SMS Medical College and Hospital
🇮🇳Jaipur, RAJASTHAN, India
AMC MET Medical college & Sheth LG General Hospital🇮🇳Ahmadabad, GUJARAT, IndiaDr Atul KansaraPrincipal investigator9825034050dratulkansara@sify.com