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
- Health Condition 1: null- Patients suffering from Perennial allergic Rhinitis
- Registration Number
- CTRI/2014/02/004439
- Lead Sponsor
- Cipla Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
1. An Ethics committee approved Informed Consent Form signed and
dated by subject and or LAR before screening procedures.
2. 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.
3. 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.
1. 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.
2. Subjects with bacterial, viral or fungal infection within 2 weeks prior to
screening visit.
3. 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
- Secondary Outcome Measures
Name Time Method