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Real-World study to evaluate Fluticasone Furoate - Oxymetazoline nasal spray in Allergic Rhinitis

A Real-World Observational study to evaluate the safety & effectiveness of Fluticasone Furoate - Oxymetazoline fixed dose combination nasal spray in patients with Allergic Rhinitis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/05/042785
Enrollment
600
Registered
2022-05-24
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: J309- Allergic rhinitis, unspecified

Interventions

Intervention1: 27.5 micrograms of Fluticasone Furoate and 50mcg of Oxymetazoline Hydrochloride nasal spray: Two spray actuations (27.5 micrograms of Fluticasone Furoate and 50mcg of Oxymetazoline Hydr

Sponsors

Zydus Healthcare Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with a clinical diagnosis of allergic rhinitis or any nasal condition where-in the treating physician deems the patient suitable to receive treatment with a combination of intranasal corticosteroid and nasal decongestant will be included in the study. No further inclusion or exclusion criteria were defined beyond the information given in the package insert.

Exclusion criteria

Exclusion criteria: No further inclusion or exclusion criteria were defined beyond the information given in the package insert.

Design outcomes

Primary

MeasureTime frame
All the patients will undergo a thorough clinical evaluation as per standard / routine hospital protocol for management of allergic rhinitis at baseline and at each follow-up. Symptom scores of the last day of treatment to be compared with that of the first day of treatment for the same patient to assess for rebound congestion.Timepoint: Baseline - Day 0 First follow up - before Day 28 Second follow up - before or on Day 28

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactDr Ashok Jaiswal

Zydus Healthcare Limited

AshokD.Jaiswal@zyduslife.com7600014339

Outcome results

None listed

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