A clinical trial to study the effect of FDC of Azelastine and Mometasone Nasal Spray in Patients with Seasonal Allergic Rhinitis (symptoms similar to those of a cold such as runny nose and sore throat, caused by an allergic reaction to an allergen such as dust, plant pollens or animal dander)

Phase 3

Completed

• Conditions: Seasonal Allergic Rhinitis

• Registration Number: CTRI/2013/01/003334
• Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary

This is open label, randomized, active controlled, parallel-group, comparative study. Study will enroll 560 patients with seasonal allergic rhinitis from different centers from India.    xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Patients will be recruited after providing written informed consent. After screening, patients will be randomized (meeting randomization criteria) in equal ratios to receive either of the products for two weeks. The primary objective of the study is to see the mean change in total nasal symptom score at the end of treatment. Secondary objective includes mean change in nasal and non-nasal symptom score and mean change in RQOL at 2 weeks.

During the study, there will be 5 study visits for efficacy, safety and tolerability assessment.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-31
• Last Update Posted: 2013-12-16

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

• Patients age ≥12 and ≤ 65 years inclusive of either sex.
• The combined score of nasal symptoms (nasal congestion, rhinorrhea, nasal itching and sneezing) must be at least 6; and nasal congestion severity score must be at least 2 at screening.
• Patient with a documented clinical history of Seasonal Allergic Rhinitis with exacerbations during the study season and/or exhibiting a positive skin prick test 4.
• Patient with ability to understand and sign written informed consent form, which must have been obtained prior to screening.
• Subjects under the legal age of consent must have provided assent and have had the written informed consent of the parent or guardian.

Exclusion Criteria

• Pregnant or lactating women.
• Patients with known hypersensitivity to any of the components of the formulation.
• Patients with a history of anaphylaxis and/or other severe local reaction(s) to skin testing 4.
• Patients with alcohol or drug dependence.
• Patients with perennial rhinitis with little or no seasonal exacerbations; non-allergic rhinitis or ocular infection within 3 weeks before the screening.
• Patients with documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip or Rhinitis Medicamentosa as determined by the investigator.
• Patients with a history of psychiatric illness.
• Patients with nasal structure abnormalities, including nasal ulceration, nasal mucosal erosion, large nasal polyps and marked septal deviations that significantly interfere with nasal air flow.
• Patients with an active pulmonary disorder, upper respiratory tract or sinus infection that required antibiotic therapy at least 14 day prior to the Screening Visit or a viral upper respiratory infection within 7 days before the Screening Visit.
• Patients with history of narrow-angle glaucoma, increased intraocular pressure, posterior subcapsular cataract, urinary retention, hypertension, severe Coronary Artery Disease, Ischemic Heart Disease, Diabetes Mellitus, Hyperthyroidism, Renal Impairment or Prostatic Hypertrophy, and those receiving monoamine oxidase (MAO) inhibitor therapy.
• Patients with current evidence of clinically significant hematopoietic, cardiovascular, hepatic renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the subject’s participation in the study.
• Particular attention should be given to exclude subjects with conditions that would currently interfere with the absorption, distribution, metabolism or excretion of the study drug or interfere with the subject’s ability to complete or reliably complete the patient’s diary.
• Patients who have participated in any clinical trial in the past 1 month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change in Total Nasal Symptoms Score from Baseline to End of treatment.	Time Point: 14 days (two weeks).

Secondary Outcome Measures

Name	Time	Method
Mean change in individual symptom scores from Baseline to End of treatment.	Time Point: 14 days (two weeks).
Patients Self Evaluation for overall Response to Treatment at the End of treatment.	Time point: 14 days (two weeks).
Mean change in Rhinoconjunctivitis Quality-of-Life Score (RQOL) from Baseline to End of treatment.	Time point: 14 days (two weeks).

Trial Locations

Locations (37)

Apex Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Apex Hospitals Private Limited; 🇮🇳 Jaipur, RAJASTHAN, India

Apex Institute of Medical Sciences; 🇮🇳 Kolkata, WEST BENGAL, India

Apollo Speciality Hospitals; 🇮🇳 Madurai, TAMIL NADU, India

BJ Government Medical College; 🇮🇳 Pune, MAHARASHTRA, India

Deogaonkar hospital; 🇮🇳 Nashik, MAHARASHTRA, India

Dr. B.R. Ambedkar Medical College; 🇮🇳 Bangalore, KARNATAKA, India

Giriraj Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Hi-Tech Medical College and Hospital; 🇮🇳 Cuttack, ORISSA, India

Institute of Post Graduate Medical Education & Research – SSKM Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

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Apex Hospital

🇮🇳Pune, MAHARASHTRA, India

Dr Shailesh Adwani

Principal investigator

919545838380

sradwani@yahoo.com