Last updated: 11/03/2018 12:40:26

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 rhinitisAVY-REG00108VN

GSK study ID
112185
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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)
Trial description: 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.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Systolic blood pressure at Screening/Visit 1, Visit 2, and Visit 3

Timeframe: 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)

Diastolic blood pressure at Screening/Visit 1, Visit 2, and Visit 3

Timeframe: 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 at Screening/Visit 1, Visit 2, and Visit 3

Timeframe: 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)

Hemoglobin values at baseline and after treatment completion

Timeframe: Baseline and treatment completion (up to Week 6)

Hematocrit values at baseline and after treatment completion

Timeframe: Baseline and treatment completion (up to Week 6)

Red blood cell count at baseline and after treatment completion

Timeframe: Baseline and treatment completion (up to Week 6)

White blood cell count at baseline and after treatment completion

Timeframe: Baseline and treatment completion (up to Week 6)

Platelet count at baseline and after treatment completion

Timeframe: Baseline and treatment completion (up to Week 6)

Sodium count at Baseline and after treatment completion

Timeframe: Baseline and treatment completion (up to Week 6)

Potassium count at Baseline and after treatment completion

Timeframe: Baseline and treatment completion (up to Week 6)

Total bilirubin value at baseline and after treatment completion

Timeframe: Baseline and treatment completion (up to Week 6)

Creatinine value at baseline and after treatment completion

Timeframe: Baseline and treatment completion (up to Week 6)

Alkaline phosphatase value at baseline and after treatment completion

Timeframe: Baseline and treatment completion (up to Week 6)

Aspartate aminotransferase (AST) value at baseline and after treatment completion

Timeframe: Baseline and treatment completion (up to Week 6)

Alanine aminotransferase (ALT) value at baseline and after treatment completion

Timeframe: Baseline and treatment completion (up to Week 6)

Glucose value at baseline and after treatment completion

Timeframe: Baseline and treatment completion (up to Week 6)

Urea nitrogen value at baseline and after treatment completion

Timeframe: Baseline and treatment completion (up to Week 6)

Total protein value at baseline and after treatment completion

Timeframe: Baseline and treatment completion (up to Week 6)

Albumin value at baseline and after treatment completion

Timeframe: Baseline and treatment completion (up to Week 6)

Number of participants with normal and abnormal electrocardiogram (ECG) results at baseline and at treatment completion

Timeframe: Baseline and treatment completion (up to Week 6)

Percentage of participants with appearance of nasal polyps and nasal ulcers at baseline and at treatment completion

Timeframe: Baseline and treatment completion (up to Week 6)

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Avamys aqueous nasal spray 110mcg
  • Enrollment:
    60
    Primary completion date:
    2010-09-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Vo Thanh Quang, Pham Tuan Canh, Nguyen Nhat Linh. A phase IV, open-label study to evaluate safety/tolerability of once-daily AVAMYSTM aqueous nasal spray 110 mcg among Vietnamese adult patients with established perennial allergic rhinitis (PAR). 2011;2(2):56-4.
    Medical condition
    Rhinitis, Allergic, Perennial
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    August 2009 to February 2010
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 1. Informed consent: Subject has provided an appropriately signed and dated informed consent.
    • 2. Outpatient: Subject is treatable on an outpatient basis.
    • A subject is not eligible for inclusion in this study if any of the following criteria applies.
    • 1. Significant concomitant medical condition(s), defined as but not limited to:

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Ha Noi, Vietnam, 084
    Status
    Study Complete

    Study documents

    Scientific result summary
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2010-09-02
    Actual study completion date
    2010-09-02

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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