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.

A randomized, single blind, comparative, three way crossover clinical study to evaluate the efficacy and safety of a novel nasal spray (FDC of Azelastine hydrochloride and Mometasone furoate monohydrate) compared to its individual components Azelastine hydrochloride 137 mcg and Mometasone furoate monohydrate 50 mcg nasal sprays in patients suffering from perennial Allergic Rhinitis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/02/004439

Enrollment

120

Registered

2014-02-28

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients suffering from Perennial allergic Rhinitis

Interventions

Intervention1: Azelastine Hyfrochloride 137 mcg: Nasal Spray Intervention2: Mometasone Furoate Monohydrate 50 mcg: Nasal Spray Intervention3: Azelastine Hydrochloride 137 mcg and Mometasone Furoate Mo

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Change in 12 hour reflective total nasal symptom score (rTNSS) and Change in 12 hour reflective total ocular symptom score (rTOSS) for active treatments.Timepoint: At 7th and 14th day of treatment from baseline	—

Secondary

Measure	Time frame
Adverse events (both drug related and unrelated)Timepoint: Throughout the study;Clinically significant changes in laboratory values, vital signs, physical examinationTimepoint: Throughout the study;Difference in number of rescue medication tablets requiredTimepoint: After 14 days treatment from baseline;Maximum PNIF response to nasal AMP challenge for active treatments (In 10 percent subjects at Chest Research Foundation)Timepoint: After 14th day from baseline;Onset of action (based on instantaneous scores iTNSS and iTOSS)Timepoint: On the day of 1st dose of each treatment for 12 hours from dosing;Overall tolerability of subject to study medicineTimepoint: Throughout the study	—

Measure

Time frame

Adverse events (both drug related and unrelated)Timepoint: Throughout the study;Clinically significant changes in laboratory values, vital signs, physical examinationTimepoint: Throughout the study;Difference in number of rescue medication tablets requiredTimepoint: After 14 days treatment from baseline;Maximum PNIF response to nasal AMP challenge for active treatments (In 10 percent subjects at Chest Research Foundation)Timepoint: After 14th day from baseline;Onset of action (based on instantaneous scores iTNSS and iTOSS)Timepoint: On the day of 1st dose of each treatment for 12 hours from dosing;Overall tolerability of subject to study medicineTimepoint: Throughout the study

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Countries

India

Contacts

Public ContactMr Abhijit Vaidya

Cipla Ltd.

jgogtay@cipla.com02223025412

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026