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
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: Avamys aqueous nasal spray 110mcg
Intervention description: 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.
Phase: Phase 4
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AVY-REG00108VN

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:

          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:

               -  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.

        Exclusion Criteria:

        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:

               1. 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.

               2. 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.

               3. Nasal (eg, nasal septum), ocular, or throat injury or surgery in the last 3
                  months

               4. Asthma at all severities

               5. Rhinitis medicamentosa

               6. 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

               7. Documented evidence of acute or significant chronic sinusitis, as determined by
                  the individual investigator.

               8. Current or history of glaucoma and/or cataracts or ocular herpes simplex

               9. Physical impairment that would affect subject's ability to participate safely and
                  fully in the study

              10. Clinical evidence of a Candida infection of the nose

              11. 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

              12. History of adrenal insufficiency

          2. 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.

          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.