Rhinitis, Allergic, PerennialPhase 4AVY-REG00108VNNCT01270958
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
A Phase 4 study testing Avamys aqueous nasal spray 110mcg in people with Rhinitis, Allergic, Perennial, run by GlaxoSmithKline at 1 site in Vietnam.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- Avamys aqueous nasal spray 110mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- Aug 2009to Feb 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent: Subject has provided an appropriately signed and dated informed consent.
- Outpatient: Subject is treatable on an outpatient basis.
- Age ≥ 18 years at Visit 1
- Male or eligible female: To be eligible for entry into the study, females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control, as defined by the following:
- Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject
- Implants of levonorgestrel
Show all 19Show fewer
- Injectable progestogen
- Oral contraceptive (either combined estrogen/progestin or progestin only)
- Any intrauterine device (IUD) with a documented failure rate of less than 1% per year, or
- Double barrier method - spermacide plus a mechanical barrier (e.g., spermacide plus a male condom or a spermacide and female diaphragm).
- Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days).
- Female subjects should not be enrolled if they plan to become pregnant during the time of study participation. A urine pregnancy test is performed at the screening visit and the final visit.
- Diagnosis of perennial allergic rhinitis (PAR)
- Documented clinical history of PAR, if available, with perennial allergy symptoms during each of the last two years
- A positive skin test (by prick method) to testing allergens within 12 months prior to or at screening visit.
- A positive skin test is defined as a wheal ≥3 mm larger than the diluent control for prick testing.
- Subjects who meet the above criteria and who may also have perennial allergic rhinitis or vasomotor rhinitis are eligible for entry to the study.
- Ability to comply with study procedures: Subject understands and is willing, able and likely to comply with study procedures and restrictions.
- Literate: Subject must be able to read, comprehend, and record information in Vietnamese.
Who cannot join
- A subject is not eligible for inclusion in this study if any of the following criteria applies.
- Significant concomitant medical condition(s), defined as but not limited to:
- Historical or current evidence of a clinically significant uncontrolled disease of any body system (e.g., tuberculosis, psychological disorders, eczema). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or which would confound the interpretation of the study results if the disease/condition exacerbated during the study.
- A severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or nasal septal perforation that could affect the deposition of intranasal study drug.
- Nasal (eg, nasal septum), ocular, or throat injury or surgery in the last 3 months
- Asthma at all severities
Show all 34Show fewer
- Rhinitis medicamentosa
- Bacterial or viral infection (e.g., common cold) of the eyes or upper respiratory tract within two weeks of Screening visit or during the screening period
- Documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator.
- Current or history of glaucoma and/or cataracts or ocular herpes simplex
- Physical impairment that would affect subject's ability to participate safely and fully in the study
- Clinical evidence of a Candida infection of the nose
- History of psychiatric disease, intellectual deficiency, poor motivation, substance abuse (including drug and alcohol) or other conditions that will limit the validity of informed consent or that would confound the interpretation of the study results
- History of adrenal insufficiency
- Use of corticosteroids, defined as:
- Intranasal corticosteroid within four weeks prior to Screening visit or Visit 1.
- Inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) within eight weeks prior to Screening visit or Visit 1.
- Use of other allergy medications within the timeframe indicated relative to Screening visit or Visit 1
- Intranasal or ocular cromolyn within 2 weeks prior to Screening visit or Visit 1
- Long-acting antihistamines within 10 days prior to Screening visit or Visit 1 (e.g., loratadine, desloratadine, fexofenadine, cetirizine)
- Intranasal antihistamines (e.g. Astelin‡ ) within 2 weeks prior to Screening visit or Visit 1
- Oral or intranasal decongestants within three days prior to Screening visit or Visit 1
- Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole.
- Contact Lens and Ocular Preparations: Subjects are not permitted to wear contact lens or use any ocular preparations, including artificial tears, eyewash/ irrigation solutions, or lubricants, during the screening and treatment periods. No exclusion period prior to screening (Visit 1) is required for these ocular products. Eye glasses are permitted during the study.
- Allergy/Intolerance: Known hypersensitivity to corticosteroids or any excipients in the product
- Clinical trial/experimental medication experience
- Has recent exposure to an investigational study drug within 30 days of Visit 1
- Participation in a previous study of intranasal fluticasone furoate
- Positive pregnancy test or female who is breastfeeding: Has a positive or inconclusive pregnancy test at Screening visit or Visit 1
- Affiliation with investigational site: Subject is a participating investigator, sub-investigator, study co-ordinator, or employee of a participating investigator, or is an immediate family member of the aforementioned.
- Current tobacco use: Subjects who have used smoking products including cigarettes, cigars, and pipe or chewing tobacco within the past year.
- Findings of a clinically significant, abnormal ECG.
- Findings of a clinically significant laboratory abnormality.
- Chickenpox or measles: A subject is not eligible if he/she currently has chickenpox or measles, or has been exposed to chickenpox or measles during the last three weeks and is nonimmune. If a subject develops chickenpox or measles during the study, he/she will be withdrawn from the study. If a non-immune subject is exposed to chickenpox or measles during the study, his/her continuation in the study will be at the discretion of the investigator, taking into consideration the likelihood of developing active disease.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read more
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.
Read the detailed 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.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- Avamys aqueous nasal spray 110mcg
- Keywords
- AVY-REG00108VN
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avamys aqueous nasal spray 110mcgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| TREATMENT | Experimental | 50 adult patients with Perennial Allergic Rhinities treated with Avamys. Receives: Drug: Avamys aqueous nasal spray 110mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3
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.
Measured: 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
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.
Measured: 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
Heart rate is measured as the number of heart beats per unit time.
Measured: 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
Hemoglobin functions primarily to transport oxygen from the lungs to the body tissues. Normal range: 125-160 grams per liter (g/L).
Measured: Baseline and treatment completion (up to Week 6)
Hematocrit Values at Baseline and After Treatment Completion
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.
Measured: Baseline and treatment completion (up to Week 6)
Red Blood Cell Count at Baseline and After Treatment Completion
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).
Measured: Baseline and treatment completion (up to Week 6)
White Blood Cell Count at Baseline and After Treatment Completion
White blood cells are cells of the immune system that defend the body against both infectious disease and foreign materials. Normal range: 4-10 10^9 cells per liter (Giga/L).
Measured: Baseline and treatment completion (up to Week 6)
Platelet Count at Baseline and After Treatment Completion
Platelets are cells found in the blood that play a role in blood clotting. Normal range: 150-400 Giga/L.
Measured: Baseline and treatment completion (up to Week 6)
Sodium Count at Baseline and After Treatment Completion
Sodium is the major positive ion (cation) found outside of cells. The balance of the electrolytes in our bodies is essential for normal function of our cells and our organs. Normal range: 135-145 millimoles per liter (mmol/L).
Measured: Baseline and treatment completion (up to Week 6)
Potassium Count at Baseline and After Treatment Completion
Potassium is the major positive ion (cation) found inside of cells. The balance of the electrolytes in our bodies is essential for normal function of our cells and our organs. Normal range: 3.5-5.0 mmol/L.
Measured: Baseline and treatment completion (up to Week 6)
Total Bilirubin Value at Baseline and After Treatment Completion
Total bilirubin is formed when hemoglobin breaks down. Bilirubin is excreted in bile and urine, and elevated levels may indicate certain diseases. Normal range: <=17 micromoles per liter (umol/L).
Measured: Baseline and treatment completion (up to Week 6)
Creatinine Value at Baseline and After Treatment Completion
Creatinine is a metabolic waste product in urine that remains relatively constant in an individual and that may be used to establish baseline renal function. Normal range: 53-100 umol/L (female) and 62-120 umol/L (male).
Measured: Baseline and treatment completion (up to Week 6)
Alkaline Phosphatase Value at Baseline and After Treatment Completion
Alkaline phosphatase is an enzyme produced by the liver or bone. An elevated level of alkaline phosphatase in the blood may indicate a liver or bone problem. Normal range: 30-120 units per liter (U/L).
Measured: Baseline and treatment completion (up to Week 6)
Aspartate Aminotransferase (AST) Value at Baseline and After Treatment Completion
AST is a liver enzyme released into the blood when certain organs or tissues, particularly the liver and heart, are injured. Normal range: <=37 U/L.
Measured: Baseline and treatment completion (up to Week 6)
Alanine Aminotransferase (ALT) Value at Baseline and After Treatment Completion
ALT is a liver enzyme that plays a role in protein metabolism. Abnormally high blood levels of ALT are a sign of liver inflammation or damage from infection or drugs. Normal range: <=40 U/L.
Measured: Baseline and treatment completion (up to Week 6)
Glucose Value at Baseline and After Treatment Completion
Glucose is a simple sugar used as a source of energy for cellular metabolism. Normal range: 3.9-6.4 mmol/L.
Measured: Baseline and treatment completion (up to Week 6)
Urea Nitrogen Value at Baseline and After Treatment Completion
The urea concentration of serum or plasma, conventionally specified in terms of nitrogen content and called blood urea nitrogen (BUN), is an important indicator of renal function. Normal range: 2.5-7.5 mmol/L.
Measured: Baseline and treatment completion (up to Week 6)
Total Protein Value at Baseline and After Treatment Completion
A total protein assay measures the amount of proteins found in the plasma. Normal range: 65-82 g/L.
Measured: Baseline and treatment completion (up to Week 6)
Albumin Value at Baseline and After Treatment Completion
Albumin is a simple water-soluble protein found in many tissues and liquids. Normal range: 35-50 g/L.
Measured: Baseline and treatment completion (up to Week 6)
Number of Participants With Normal and Abnormal Electrocardiogram (ECG) Results at Baseline and at Treatment Completion
The electrocardiogram is a recording of the electrical activity of the heart as it undergoes excitation (depolarization) and recovery (polarization) to initiate each beat of the heart. Normal ECG readings show a slight flat-dip in between contractions and relaxations. An abnormal ECG is determined by comparing the results of an ECG graph with a standard or normal heart graph. If these flat-dips are not present, it may be an indication of a more serious problem.
Measured: 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
Nasal polyps are non cancerous growths occurring in the nose or sinuses. Nasal ulcers are a break in skin or mucous membrane with loss of surface tissue, disintegration and necrosis of epithelial tissue.
Measured: Baseline and treatment completion (up to Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startAug 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, Allergic, PerennialStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270958
- Sponsor's protocol ID
- 112185
- Acronym
- AVY-REG00108VN
- Status last verified
- Aug 2014
- First submitted
- 31 Aug 2010
- Last updated
- 6 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01270958
- Acronym / sponsor ID
- AVY-REG00108VN / 112185
- Conditions
- Rhinitis, Allergic, Perennial
- Keywords
- AVY-REG00108VN
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 5 Jan 2011 (estimated)
- Results
- Posted 5 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TREATMENT | Experimental | Drug: Avamys aqueous nasal spray 110mcg50 adult patients with Perennial Allergic Rhinities treated with Avamys. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Informed consent: Subject has provided an appropriately signed and dated informed consent.
- Outpatient: Subject is treatable on an outpatient basis.
- Age ≥ 18 years at Visit 1
- Male or eligible female: To be eligible for entry into the study, females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control, as defined by the following:
- Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days).
Key exclusion criteria (34 listed)
- A subject is not eligible for inclusion in this study if any of the following criteria applies.
- Significant concomitant medical condition(s), defined as but not limited to:
- Use of corticosteroids, defined as:
- Use of other allergy medications within the timeframe indicated relative to Screening visit or Visit 1
- Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avamys aqueous nasal spray 110mcgAt 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. | Drug | TREATMENT |
Primary outcome
Systolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
White Blood Cell Count at Baseline and After Treatment Completion
Time frame: Baseline and treatment completion (up to Week 6)
White blood cells are cells of the immune system that defend the body against both infectious disease and foreign materials. Normal range: 4-10 10^9 cells per liter (Giga/L).
Platelet Count at Baseline and After Treatment Completion
Time frame: Baseline and treatment completion (up to Week 6)
Platelets are cells found in the blood that play a role in blood clotting. Normal range: 150-400 Giga/L.
Sodium Count at Baseline and After Treatment Completion
Time frame: Baseline and treatment completion (up to Week 6)
Sodium is the major positive ion (cation) found outside of cells. The balance of the electrolytes in our bodies is essential for normal function of our cells and our organs. Normal range: 135-145 millimoles per liter (mmol/L).
Potassium Count at Baseline and After Treatment Completion
Time frame: Baseline and treatment completion (up to Week 6)
Potassium is the major positive ion (cation) found inside of cells. The balance of the electrolytes in our bodies is essential for normal function of our cells and our organs. Normal range: 3.5-5.0 mmol/L.
Total Bilirubin Value at Baseline and After Treatment Completion
Time frame: Baseline and treatment completion (up to Week 6)
Total bilirubin is formed when hemoglobin breaks down. Bilirubin is excreted in bile and urine, and elevated levels may indicate certain diseases. Normal range: <=17 micromoles per liter (umol/L).
Creatinine Value at Baseline and After Treatment Completion
Time frame: Baseline and treatment completion (up to Week 6)
Creatinine is a metabolic waste product in urine that remains relatively constant in an individual and that may be used to establish baseline renal function. Normal range: 53-100 umol/L (female) and 62-120 umol/L (male).
Alkaline Phosphatase Value at Baseline and After Treatment Completion
Time frame: Baseline and treatment completion (up to Week 6)
Alkaline phosphatase is an enzyme produced by the liver or bone. An elevated level of alkaline phosphatase in the blood may indicate a liver or bone problem. Normal range: 30-120 units per liter (U/L).
Aspartate Aminotransferase (AST) Value at Baseline and After Treatment Completion
Time frame: Baseline and treatment completion (up to Week 6)
AST is a liver enzyme released into the blood when certain organs or tissues, particularly the liver and heart, are injured. Normal range: <=37 U/L.
Alanine Aminotransferase (ALT) Value at Baseline and After Treatment Completion
Time frame: Baseline and treatment completion (up to Week 6)
ALT is a liver enzyme that plays a role in protein metabolism. Abnormally high blood levels of ALT are a sign of liver inflammation or damage from infection or drugs. Normal range: <=40 U/L.
Glucose Value at Baseline and After Treatment Completion
Time frame: Baseline and treatment completion (up to Week 6)
Glucose is a simple sugar used as a source of energy for cellular metabolism. Normal range: 3.9-6.4 mmol/L.
Urea Nitrogen Value at Baseline and After Treatment Completion
Time frame: Baseline and treatment completion (up to Week 6)
The urea concentration of serum or plasma, conventionally specified in terms of nitrogen content and called blood urea nitrogen (BUN), is an important indicator of renal function. Normal range: 2.5-7.5 mmol/L.
Total Protein Value at Baseline and After Treatment Completion
Time frame: Baseline and treatment completion (up to Week 6)
A total protein assay measures the amount of proteins found in the plasma. Normal range: 65-82 g/L.
Albumin Value at Baseline and After Treatment Completion
Time frame: Baseline and treatment completion (up to Week 6)
Albumin is a simple water-soluble protein found in many tissues and liquids. Normal range: 35-50 g/L.
Number of Participants With Normal and Abnormal Electrocardiogram (ECG) Results at Baseline and at Treatment Completion
Time frame: Baseline and treatment completion (up to Week 6)
The electrocardiogram is a recording of the electrical activity of the heart as it undergoes excitation (depolarization) and recovery (polarization) to initiate each beat of the heart. Normal ECG readings show a slight flat-dip in between contractions and relaxations. An abnormal ECG is determined by comparing the results of an ECG graph with a standard or normal heart graph. If these flat-dips are not present, it may be an indication of a more serious problem.
Percentage of Participants With Appearance of Nasal Polyps and Nasal Ulcers at Baseline and at Treatment Completion
Time frame: Baseline and treatment completion (up to Week 6)
Nasal polyps are non cancerous growths occurring in the nose or sinuses. Nasal ulcers are a break in skin or mucous membrane with loss of surface tissue, disintegration and necrosis of epithelial tissue.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundVo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Avamys aqueous nasal spray 110mcg in people with Rhinitis, Allergic, Perennial, run by GlaxoSmithKline at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3 (time frame: 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)). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01270958, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2014.