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
Trial overview
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)
- 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:
- 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. 5. 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. 6. Ability to comply with study procedures: Subject understands and is willing, able and likely to comply with study procedures and restrictions. 7. Literate: Subject must be able to read, comprehend, and record information in Vietnamese.
1. Informed consent: Subject has provided an appropriately signed and dated informed consent. 2. Outpatient: Subject is treatable on an outpatient basis. 3. Age ≥ 18 years at Visit 1 4. 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:
- 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. 3. 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 4. Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole. 5. 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. 6. Allergy/Intolerance: Known hypersensitivity to corticosteroids or any excipients in the product 7. 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 8. Positive pregnancy test or female who is breastfeeding: Has a positive or inconclusive pregnancy test at Screening visit or Visit 1 9. 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. 10. Current tobacco use: Subjects who have used smoking products including cigarettes, cigars, and pipe or chewing tobacco within the past year. 11. Findings of a clinically significant, abnormal ECG. 12. Findings of a clinically significant laboratory abnormality. 13. 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.
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: a) 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. b) 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. c) Nasal (eg, nasal septum), ocular, or throat injury or surgery in the last 3 months d) Asthma at all severities e) Rhinitis medicamentosa f) 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 g) Documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator. h) Current or history of glaucoma and/or cataracts or ocular herpes simplex i) Physical impairment that would affect subject’s ability to participate safely and fully in the study j) Clinical evidence of a Candida infection of the nose k) 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 l) History of adrenal insufficiency 2. Use of corticosteroids, defined as:
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
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.