A clinical trial to study the effect of, Fluticasone Nasal Spray BP (Mfd. By Biodeal Laboratories Pvt. Ltd.) Vs Fluticasone Nasal Spray BP (Mfd. By Glaxosmithkline Pharmaceuticals Ltd) in patients with Allergic Rhinitis

A randomized double-blind multicentric prospective clinical trial to compare the efficacy, safety and tolerability of Fluticasone Nasal Spray BP (Mfd. By Biodeal Laboratories Pvt. Ltd.) Vs Fluticasone Nasal Spray BP (Mfd. By Glaxosmithkline Pharmaceuticals Ltd) in patients with Allergic Rhinitis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000135

Enrollment

125

Registered

2010-02-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Fluticasone Nasal Spray BP: One spray in each nostril twice a day. morning and evening) Control Intervention1: Fluticasone Nasal Spray BP: One spray in each nostril twice a day. morning

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 - 60 years. 2. Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent. 3. Patient with history, signs & symptoms of Allergic Rhinitis.

Exclusion criteria

Exclusion criteria: 1.Patients < 18 & > 60 years 2.History of hypersensitivity to the study drug or similar class of drug. 3.Significant history or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications. 4.Pregnant or lactating women. 5.Patients with serum creatinine greater than 2.5 mg/dl. 6.Patients with raised SGPT and total bilirubin greater than 50% above the upper normal limits 7.Significant history or presence of glaucoma, cardiovascular or hematological disease. 8.Any clinical significant illness during the 4 weeks prior to day 1 of this study. 9.Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease. 10.Participation in a clinical trial with an investigation drug within 30 days proceeding day one of this study. 11.Use of enzyme-modifying drugs within 30 days prior to day 1 of this study. 12.HIV and Australian Antigen positive subjects. 13.Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study.

Design outcomes

Primary

Measure	Time frame
Change in signs and symptoms (Clinical efficacy parameters) i.e. Sore Throat, Cough, Sneezing, Headache and Temperature at the end of Treatment.Timepoint: At Baseline, Day 7 and Day 14	—

Secondary

Measure	Time frame
Improvement in Global Assessment of efficacy and tolerability of treatment which will be judged by patients and physicians and to assess adverse events.Timepoint: At Baseline, Day 7 and Day 14	—

Countries

India

Contacts

Public ContactMr. Manoj Vora

manojvora@biodealindia.com42103880

Outcome results