Efficacy and safety of Fluticasone furoate with montelukast vs Fluticasone furoate with Cetirizine in patients with allergic rhinitis

Clinical efficacy and safety of Fluticasone furoate with cetrizine vs Fluticasone furoate with montelukast in patients with allergic rhinitis - A Randomized open label controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/059253

Enrollment

Registered

2023-10-30

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: J309- Allergic rhinitis, unspecified

Interventions

Intervention1: Fluticasone Furoate and Montelukast: Fluticasone furoate spray ( 2 sprays actuation in each nostrils 2 times daily) + 1 tablet montelukast 10mg at night time for 4 weeks Control Interve

Eligibility

Inclusion criteria

Inclusion criteria: Willing to sign informed consent form. Patients suffering from Allergic Rhinitis. Not being using Nasal steroids for past one month. 4 out of 12 Total Nasal Symptom Score(TNSS).

Exclusion criteria

Exclusion criteria: Pregnancy and lactating women. Known history of psychiatric illness. Planned surgery of nasal cavity. Patient with unknown malignancies.

Design outcomes

Primary

Measure	Time frame
TNSS (total Nasal Symptom Score ) and nasal eosinophil count will be estimated in order to efficacy of Fluticasone furoate with Montelukast Vs Fluticasone furoate with cetirizineTimepoint: At baseline (0th day) and on 30th day day	—

Secondary

Measure	Time frame
To assess the ADR during study periodTimepoint: 4 weeks	—

Countries

India

Contacts

Public ContactS.K.Shini Rubina

SRM College of Pharmacy , SRM Institute of Science and Technology

saruprabakar@gmail.com7010530419

Outcome results

None listed

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