A Study to Compare the Efficacy and Safety of Fluticasone Furoate Nasal Sprays (FFNS) 55 Microgram (mcg) and 110 mcg in Chinese Pediatric Subjects With Allergic Rhinitis (AR)
Condition: Rhinitis, Allergic, Perennial and Seasonal; Rhinitis, Allergic
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: FFNS; Placebo
Intervention description: FF as a aqueous suspension for intranasal inhalation with unit dose strength of 27.5 mcg per dose administered via a metered side-actuated nasal spray device.; Placebo as a aqueous suspension to match the other study treatments minus the active component(s) for intranasal inhalation administered via a metered side-actuated nasal spray device.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 358.0
Sex: All
Minimum age: 2 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Seasonal; Fluticasone Furoate; Perennial; Allergic Rhinitis; Nasal Spray

Summary:

      This Phase IV interventional study is a multi-center, randomized, double-blind,
      placebo-controlled parallel study to evaluate the efficacy and safety of FFNS110 mcg and 55
      mcg once daily versus vehicle placebo aqueous nasal spray in chinese pediatric subjects ages
      2 to 12 years with AR.

      This study comprises screening and run-in period (4 to14 days), double-blind treatment period
      (28 days) and follows up period (3 to7 days). Subjects entering the study will participate
      for maximum of 50 days, including five clinical visits and a follow-up contact.

      The study is planned to enroll approximately 360 subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated informed consent obtained from the subject's parent/guardian.

          -  Chinese male or non-child bearing potential female pediatric outpatients subjects who
             are >=2 to <=12 years of age at Visit 2.

          -  Diagnosis of AR: Subjects must have a diagnosis of intermittent allergy rhinitis (IAR)
             [symptoms are present <4 days a week, or for <4 weeks] or persistent allergic rhinitis
             (PER) [symptoms are present >=4 days a week, or for >=4 weeks] by symptoms, physical
             signs skin prick test (SPT) and serum-specific immunoglobulin E (IgE) test. Subjects
             must have 2 or more symptoms of AR (watery rhinorrhea, nasal obstruction, nasal
             itching and sneezing), which are also present consecutively or accumulatively more
             than 1 hour on each day prior to Visit 1, or/and concomitant ocular symptoms: ocular
             itching, red eyes, watery eyes etc. The physical signs includes: nasal mucosa pale,
             oedema, nasal secretion. Allergic shiner and allergic crease in severity pediatric. A
             documented positive prick skin test and a positive serum specific IgE test using
             standardized allergen extract. A positive skin test is defined as a allergen wheal >=3
             millimeters (mm), a histamine >=3 mm. Subjects have nasal symptoms described above
             or/and associated with ocular symptoms, as well as the nasal signs and one of
             laboratory test positive or demonstrate SPT represented a positive response or
             serum-specific IgE testing represented a positive response within 12 months prior to
             Visit 1.

          -  Subject must be willing to maintain same environment throughout the study.

          -  Subject and/or subject's parent/guardian understands and is willing, able and likely
             to comply with study procedures and restrictions as well as manage study drug
             administration.

        Exclusion Criteria:

          -  Concomitant Medical Conditions: (a) Significant concomitant medical conditions defined
             as historical or current evidence of clinically significant uncontrolled disease of
             any body system. Significant is defined as any disease that, in the opinion of the
             investigator, would confound the interpretation of the study results if the
             disease/condition exacerbated during the study: significant renal impairment, which
             based on the opinion of the investigator, would preclude the subjects' participation
             in the study and current active liver or biliary disease (with the exception of
             Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver
             disease per investigator assessment). (NOTES: Stable chronic liver disease should
             generally be defined by the absence of ascites, encephalopathy, coagulopathy,
             hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice, or cirrhosis
             and Chronic stable hepatitis B and C [e.g., presence of hepatitis B surface antigen
             (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months
             prior to first dose of study treatment] are acceptable if subject otherwise meets
             entry criteria). (b) A severe physical obstruction of the nose (e.g., deviated septum
             or nasal polyp) or frequent bleeding of the nose that could affect the deposition of
             double blind intranasal study drug. (c) Current or history of a Candida infection of
             the nose or oropharynx, shingles, chickenpox, measles, ocular herpes simplex. (d)
             Known hypersensitivity to corticosteroids or any excipients in the product. (e) Recent
             nasal septal surgery or nasal septal perforation. (f) Subjects start, discontinue or
             change desensitization treatment within 30 days prior to Visit 1. (g) Bacterial or
             viral infection of the eyes or upper respiratory tract within two weeks of Visit 1 or
             during the screening period. (h) Asthma, with the exception of mild intermittent
             asthma. (i) Diagnosis of rhinitis medicamentosa, vasomotor AR or eosinophil rhinitis.

          -  Abnormal Laboratory Findings: A clinically significant laboratory abnormality
             including Liver Function Tests at Visit 1 meeting the following criteria: Alanine
             aminotransferase (ALT) >2 x upper limit of normal (ULN) and bilirubin >1.5xULN
             (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct
             bilirubin <35 percent [%]).

          -  Abnormal Electocardiogram (ECG): Clinically significant abnormal ECG finding at Visit
             1. Significant is defined as: Corrected QT (QTc) > 450 milliseconds (msec) or QTc >
             480 msec in subjects with Bundle Branch Block. The QTc is the QT interval corrected
             for heart rate according to Bazett's formula (QTcB), Fridericia's formula (QTcF),
             and/or another method, machine-read or manually over-read. The specific formula that
             will be used to determine eligibility and discontinuation for an individual subject
             should be determined prior to initiation of the study. In other words, several
             different formulae cannot be used to calculate the QTc for an individual subject and
             then the lowest QTc value used to include or discontinue the subject from the trail.

          -  Concomitant Medication: Use of prescription or over-the-counter medication that would
             significantly affect the course of AR, or interact with study drug, such as: Chronic
             use of concomitant medications such as tricyclic antidepressants, that would affect
             assessment of the effectiveness of the study drug; Chronic use of long- acting
             beta2-agonists (e.g., salmeterol); Potent Cytochrome P450 subfamily enzyme 3A4
             [CYP3A4] inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin,
             etc); Allergen immunotherapy for the treatment of allergies.

          -  Use of followings medications are not allowed throughout the study: Short-acting
             antihistamines, including ocular preparations and antihistamines contained in
             anti-cold medicine, insomnia or antalgic; Oral or inhaled anticholinergics; Oral or
             intranasal decongestants; Oral or intranasal antileukotrienes; Oral or inhaled
             long-acting beta2 agonists; Chinese traditional medicines that have potential effect
             to AR; Liquorice preparation; Medications that significantly inhibit the CYP3A4,
             including ritonavir and ketoconazole; tricyclic antidepressants; long-acting
             antihistamines( eg. desloratadine, fexofenadine, cetirizine and loratadine [ taken as
             rescue medication]); Intranasal antihistamines; or Intranasal or ocular cromolyh;
             Intranasal corticosteroids includes: Inhaled, oral, intramuscular, intravenous, ocular
             and/or dermatological corticosteroid (with the exception of hydrocortisone
             cream/ointment, 1% or less) and Immunosuppressive medications; Subcutaneous
             omalizumab.

          -  Subjects will travel more than 48 hours during the study may cause the change of
             allergen.

          -  Subjects, who, in the opinion of the Investigator or sub-investigators, are not able
             to comply with the protocol requirements.