Last reviewed · How we verify
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) (AVY-REG00108VN)
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.
Details
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 60 |
| Start date | 2009-08 |
| Completion | 2010-02 |
Conditions
- Rhinitis, Allergic, Perennial
Interventions
- Avamys aqueous nasal spray 110mcg
Primary outcomes
- Systolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3 — Screening/Visit 1 (3-5 days after Screening Visit), Visit 2 (14 [± 1] days after Visit 1, or Day 15), and Visit 3 (42 [± 1] days after Visit 1, or Day 43)
Blood pressure (BP) is the pressure exerted by circulating blood upon the walls of blood vessels. During each heartbeat, BP varies between a maximum (systolic) and a minimum (diastolic) pressure. - Diastolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3 — Screening/Visit 1 (3-5 days after Screening Visit), Visit 2 (14 [± 1] days after Visit 1, or Day 15), and Visit 3 (42 [± 1] days after Visit 1, or Day 43)
Blood pressure (BP) is the pressure exerted by circulating blood upon the walls of blood vessels. During each heartbeat, BP varies between a maximum (systolic) and a minimum (diastolic) pressure. - Heart Rate at Screening/Visit 1, Visit 2, and Visit 3 — Screening/Visit 1 (3-5 days after Screening Visit), Visit 2 (14 [± 1] days after Visit 1, or Day 15), and Visit 3 (42 [± 1] days after Visit 1, or Day 43)
Heart rate is measured as the number of heart beats per unit time. - Hemoglobin Values at Baseline and After Treatment Completion — Baseline and treatment completion (up to Week 6)
Hemoglobin functions primarily to transport oxygen from the lungs to the body tissues. Normal range: 125-160 grams per liter (g/L). - Hematocrit Values at Baseline and After Treatment Completion — Baseline and treatment completion (up to Week 6)
Hematocrit is the proportion of blood volume that is occupied by red blood cells. The hematocrit (Hct) is expressed as liter of red blood cells in liters of blood. Normal range: 0.35-0.50 Liter/Liter. - Red Blood Cell Count at Baseline and After Treatment Completion — Baseline and treatment completion (up to Week 6)
Red blood cells are cells in the blood that are used to transport oxygen throughout the body. Normal range: 3.9-5.8 10\^12 cells per liter (Tetra/L).
Countries
Vietnam