A Phase-IV, Open-label Study to Evaluate Safety/Tolerability of Once-daily AVAMYS (TM) Aqueous Nasal Spray 110mcg Among Vietnamese Adult Patients With Established Perennial Allergic Rhinitis — AVY-REG00108VN  

Rhinitis, Allergic, Perennial Clinical Trial

Official title: A Phase-IV, Open-label Study to Evaluate Safety/Tolerability of Once-daily AVAMYS (TM) Aqueous Nasal Spray 110mcg Among Vietnamese Adult Patients With Established Perennial Allergic Rhinitis (PAR)

Status Completed

Clinical Trial Summary

Allergic rhinitis is an IgE-mediated, inflammatory disorder of the upper airway that occurs following allergen exposure. Perennial Allergic Rhinitis (PAR) starts in early childhood and occurs all year around. It's caused by allergy to the aerosolised droppings of house dust mites and pet skin flakes (dander). Occasionally, indoor mould spores and, in rare cases, food allergy can be causes.

Intranasal corticosteroids are highly effective medications for controlling the nasal symptoms that accompany allergic rhinitis.

AVAMYS (TM) (fluticasone furoate aqueous nasal spray 100mcg) has been shown having effects on nasal symptoms of seasonal and perennial allergic rhinitis and on the ocular symptoms of allergic rhinitis and has been evaluated as effective and safe for treatment seasonal and perennial allergic rhinitis by FDA. It is speculated that AVAMYS (TM) is also effective and safe for Vietnamese patients. However before being used widely for patients across the country, AVAMYS (TM) should be proved that it is safe for Vietnamese patients.

The objective of this study is to evaluate the safety of fluticasone furoate aqueous nasal spray 110mcg once daily in adults with PAR.

This is a 6-week, open trial. A study center will be enlisted to recruit a minimum of 50 PAR subjects.

At the visit 1, subjects who fulfill the inclusion criteria are eligible to be included in the group to self-administer intranasal treatment of fluticasone furoate aqueous nasal spray 110 mcg once daily for 6 week. The subjects are instructed to administer two sprays from the device into each nostril once daily every morning. Administration of the dose will be performed by alternately spraying one spray to each nostril followed by a second spray to each nostril. Subjects will not be permitted to take any anti-allergy or rhinitis medication during the screening or treatment period.

Throughout the study, subjects will document their study drug administration/compliance, any medical conditions experienced, and any concomitant medications taken. All subjects are outpatients.

The safety assessments include a summary of the frequency and type of clinical adverse events that occur during the study. In addition, hematology and chemistry analyses of blood samples are also implemented. A physical examination and nasal examination are also performed and vital signs collected. Twelve-lead ECGs are performed at all visits.

Clinical Trial Description

Rationale Allergic rhinitis is an IgE-mediated, inflammatory disorder of the upper airway that occurs following allergen exposure. Perennial Allergic Rhinitis (PAR) starts in early childhood and occurs all year around. It's caused by allergy to the aerosolised droppings of house dust mites and pet skin flakes (dander). Occasionally, indoor mould spores and, in rare cases, food allergy can be causes.

Intranasal corticosteroids are highly effective medications for controlling the nasal symptoms that accompany allergic rhinitis.

AVAMYS (TM) (fluticasone furoate aqueous nasal spray 100mcg) has been shown having effects on nasal symptoms of seasonal and perennial allergic rhinitis and on the ocular symptoms of allergic rhinitis and has been evaluated as effective and safe for treatment seasonal and perennial allergic rhinitis by FDA. It is speculated that AVAMYS (TM) is also effective and safe for Vietnamese patients. However before being used widely for patients across the country, AVAMYS (TM) should be proved that it is safe for Vietnamese patients.

Objective(s) The objective of this study is to evaluate the safety of fluticasone furoate aqueous nasal spray 110mcg once daily in adults with PAR.

As treatment duration of duration of PAR is normally longer than that of SAR, the safety/tolerability evaluation of PAR treatment is well sufficient for the similar evaluation of SAR.

Safety Endpoints

• Frequency of solicited clinical adverse events (headache, epistaxis, pharyngolaryngeal pain)

• Vital signs (systolic and diastolic blood pressure, heart rate [pulse])

• Clinical laboratory tests at baseline, during and at study termination, specifically as follows:

Chemistry: Glucose, ALT & AST, Total Bilirubin, Alkaline phosphatase, Total Protein & Albumin Hematology: Complete Blood Count (CBC) Pregnancy test: Urine pregnancy test for all female subjects at Screening, Visit 2 & Visit 3.

• 12-lead electrocardiograms (ECGs) at baseline and at study termination

Study Design This is a 6-week, open trial. A study center will be enlisted to recruite a minimum of 50 PAR subjects. At the visit 1, subjects who fulfil the inclusion criteria are eligible to be include in the group to self-administer intranasal treatment of fluticasone furoate aqueous nasal spray 110 mcg once daily for 6 week. The subjects are instructed to administer two sprays from the device into each nostril once daily every morning. Administration of the dose will be performed by alternately spraying one spray to each nostril followed by a second spray to each nostril. Subjects will not be permitted to take any anti-allergy or rhinitis medication during the screening or treatment period.

Throughout the study, subjects will document their study drug administration/compliance, any medical conditions experienced, and any concomitant medications taken. All subjects are outpatients. Clinic visits for a study subject are scheduled to occur at the following intervals:

Screening visit: To collect Inform Consent Form and evaluate eligibility, medical history, clinical status, electrocardiography and necessary laboratory testing. If a subject is eligible and is not on any anti-histamin medications, he/she can enter the study right at this visit (i.e. on study medication).

Visit 1: Three to five days after the screening visit. This visit is due to a subject who is eligible and is on an anti-histamin medication at the screening visit. The subject must have been discontinued the anti-histamin medication(s) since the screening visit. He/she is then clinically evaluated, prescribed with study drug and instructed how to fill the Diary Card.

Visit 2: Fourteen ( ± 1) day after Visit 1 or Day 15. Clinical evaluation, drug accountability, Diary card collection and study-specific laboratory testings are applied.

Visit 3: Forty-two ( ± 1) day after Visit 1. Clinical evaluation, drug accountability, Diary card collection and study-specific laboratory testings are applied. All study information in the Case Report Form (CRF) of the subject is reviewed. A PAR subject is considered to fulfill the study only when this visit is completed.

A follow-up telephone contact is made 3 to 5 days after Visit 3/Early Withdrawal to assess for any adverse effects after discontinuing study treatment.

Study Population A minimum of 50 adults with perennial allergic rhinitis (PAR) are recruited for this study.

Study Assessments The safety assessments include a summary of the frequency and type of clinical adverse events that occur during the study. In addition, hematology and chemistry analyses of blood samples are also implemented. A physical examination and nasal examination are also performed and vital signs collected. Twelve-lead ECGs are performed at all visits. ;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Perennial

• NCT number: NCT01270958
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Completed
• Phase: Phase 4
• Start date: August 2009
• Completion date: February 2010