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A study to compare single drug versus two drugs in Allergic Rhinitis Patients.

Efficacy,Safety and FeNO monitoring of Fluticasone furoate Intranasal spray alone versus Azelastine hydrochloride Intranasal spray combined with Fluticasone furoate Intranasal spray in moderate to severe Allergic Rhinitis. - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/086607
Enrollment
300
Registered
2025-05-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: J308- Other allergic rhinitis

Interventions

Intervention1: Intranasal Azelastine hydrochloride spray combined with Fluticasone furoate Intranasal spray: Fluticasone Furoate intranasal spray 27.5 g combined with Azelastine hydrochloride nasal s

Sponsors

Dr Sumitha A Self
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients diagnosed with Moderate to severe allergic rhinitis. Patients willing to give consent for participating in the study.

Exclusion criteria

Exclusion criteria: Patients with asthma (by clinical findings and spirometric method) Patients with Chronic Obstructive Pulmonary disease (COPD). Patients with nasal bleeding,deviated nasal septum,obstructing nasal polyps,Paranasal sinuses (by ENT examination) Tuberculosis patients. Diabetic and Hypertensive patients. Smokers. Patients who received systemic or topical corticosteroids,Intranasal antihistamines, herbal drugs within the previous month of enrolment. Previous history of hypersensitivity to steroids,antihistamines. Patients with history of atopic dermatitis,tropical eosinophilia syndrome. Patients who received oral antihistamines/other drugs for upper respiratory tract infection within the previous month of enrolment. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
To assess the changes (reduction in scores) in total nasal symptom score (TNSS). To evaluate the percentage of reduction in FeNO (Fractional exhaled nitric oxide) levels. To assess the changes in Serum IgE levels.Timepoint: Baseline,1 st month of treatment and 3rd month of followup.

Secondary

MeasureTime frame
1.To assess the changes in Absolute eosinophil count. 2.Adverse drug reactions recorded (history) during the study period.Timepoint: Basline,1 st month of treatment and 3 rd month of followup.

Countries

India

Contacts

Public ContactDr C S Brethis

ACS Medical college and Hospital,Dr MGR Educational and Research Institute

brethis.pharma@acsmch.ac.in9751666924

Outcome results

None listed

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