Phase 4
N=60
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
Rhinitis, Allergic, Perennial
Bottom Line
View on ClinicalTrials.gov: NCT01270958 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jan 2011
Primary outcome: Primary: Systolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3 — 110.98; 110.63; 110.00 millimeters of mercury (mmHg) — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Avamys aqueous nasal spray 110mcg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3 |
110.98; 110.63; 110.00 | >0.05 |
| PRIMARY Diastolic Blood Pressure at Screening/Visit 1, Visit 2, and Visit 3 |
70.36; 71.79; 70.63 | >0.05 |
| PRIMARY Heart Rate at Screening/Visit 1, Visit 2, and Visit 3 |
72.80; 73.95; 73.04 | >0.05 |
| PRIMARY Hemoglobin Values at Baseline and After Treatment Completion |
137.20; 136.16 | >0.05 |
| PRIMARY Hematocrit Values at Baseline and After Treatment Completion |
0.40; 0.40 | >0.05 |
| PRIMARY Red Blood Cell Count at Baseline and After Treatment Completion |
4.49; 4.45 | >0.05 |
| PRIMARY White Blood Cell Count at Baseline and After Treatment Completion |
7.29; 7.08 | >0.05 |
| PRIMARY Platelet Count at Baseline and After Treatment Completion |
259.80; 255.16 | >0.05 |
| PRIMARY Sodium Count at Baseline and After Treatment Completion |
138.09; 139.13 | <0.01 sig |
| PRIMARY Potassium Count at Baseline and After Treatment Completion |
3.84; 3.90 | >0.05 |
| PRIMARY Total Bilirubin Value at Baseline and After Treatment Completion |
11.91; 13.54 | >0.05 |
| PRIMARY Creatinine Value at Baseline and After Treatment Completion |
90.21; 89.71 | >0.05 |
| PRIMARY Alkaline Phosphatase Value at Baseline and After Treatment Completion |
73.05; 68.02 | >0.05 |
| PRIMARY Aspartate Aminotransferase (AST) Value at Baseline and After Treatment Completion |
26.50; 25.78 | >0.05 |
| PRIMARY Alanine Aminotransferase (ALT) Value at Baseline and After Treatment Completion |
26.57; 24.29 | >0.05 |
| PRIMARY Glucose Value at Baseline and After Treatment Completion |
5.07; 5.15 | >0.05 |
| PRIMARY Urea Nitrogen Value at Baseline and After Treatment Completion |
5.78; 6.13 | >0.05 |
| PRIMARY Total Protein Value at Baseline and After Treatment Completion |
76.61; 76.89 | >0.05 |
| PRIMARY Albumin Value at Baseline and After Treatment Completion |
44.95; 45.22 | >0.05 |
| PRIMARY Number of Participants With Normal and Abnormal Electrocardiogram (ECG) Results at Baseline and at Treatment Completion |
56; 0; 56; 0 | — |
| PRIMARY Percentage of Participants With Appearance of Nasal Polyps and Nasal Ulcers at Baseline and at Treatment Completion |
0; 0; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
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.
Exclusion Criteria
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
- 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
Data sourced from ClinicalTrials.gov (NCT01270958). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.