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

NCT01270958 | Completed Phase 4 Results

• 1 other identifier: 112185
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rhinitis, Allergic, Perennial

Keywords

AVY-REG00108VN

Outcome Measures

Primary Outcomes (21)

• 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.

  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.

  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.

  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).

  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.

  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).

  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).

  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.

  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).

  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.

  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).

  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).

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline and treatment completion (up to Week 6)

Study Arms (1)

TREATMENT

EXPERIMENTAL

50 adult patients with Perennial Allergic Rhinities treated with Avamys.

Drug: Avamys aqueous nasal spray 110mcg

Interventions

Avamys aqueous nasal spray 110mcg DRUG

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.

TREATMENT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Hà Nội, 084, Vietnam

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2010
• First Posted: January 5, 2011
• Study Start: August 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: August 6, 2014
• Results First Posted: January 5, 2011

Record last verified: 2014-08

Locations

VN (1)