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)

NCT02424539 | Completed Phase 4 Results

• 1 other identifier: 201492
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Rhinitis, Allergic, Perennial and Seasonal; Rhinitis, Allergic

Keywords

Seasonal; Fluticasone Furoate; Perennial; Allergic Rhinitis; Nasal Spray

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over the First 2 Weeks Treatment Period

  TNSS is a composite score of the four components (nasal congestion, itching, rhinorrhea and sneezing) with a total score of 0 to 12. A higher score means a worse nasal symptom. The score of each component ranges from 0 (no symptom) to 3 (severe symptoms). Participants were instructed to provide scores in a reflective manner using their diary. The daily rTNSS was the average of the morning rTNSS and evening rTNSS assessments. The daily scores were averaged to calculate the overall/total score. The morning reflective assessment was performed prior to administering the morning dose. The evening reflective assessment was performed approximately 12 hours after dosing but before bedtime. Baseline scores obtained over "4 days prior to randomization" were average of the last 8 rTNSS assessments (4 AM assessments, 4 PM assessments) over the consecutive four 24-hours periods prior to randomization. Change from Baseline was defined as post-dose visit value minus Baseline value.

  Baseline and up to Week 2

Secondary Outcomes (18)

• Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale

  Week 2

• Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 2 Weeks

  Baseline and up to Week 2

• Mean Change From Baseline Over the First 2 Weeks in the Daily, Reflective Total Ocular Symptoms Score (rTOSS)

  Baseline and up to Week 2

• Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 2 Weeks Treatment Period

  Baseline and up to Week 2

• Mean Change From Baseline in Daily rTNSS Over the 4 Weeks Treatment Period

  Baseline and up to Week 4

Study Arms (3)

FFNS 55 mcg Arm

EXPERIMENTAL

Each subject will be dispensed with two nasal spray device labelled as Device A and Device B containing either FF or Placebo. Subject's on their own or with assistance from parent/guardian will administer FFNS 55 mcg per day, one intranasal spray from Device A, once daily into each nostril (27.5 mcg per spray) and another spray of placebo nasal spray from Device B, once daily into each nostril, in the morning for 4 Weeks.

Drug: FFNS; Other: Placebo

FFNS 110 mcg Arm

EXPERIMENTAL

Each subject will be dispensed with two nasal spray device labelled as Device A and Device B containing FF or Placebo. Subject's on their own or with assistance from parent/guardian will administer FFNS 110 mcg per day, one intranasal spray from Device A, once daily into each nostril (27.5 mcg per spray) and another spray of placebo nasal spray from Device B, once daily into each nostril, in the morning for 4 Weeks.

Drug: FFNS; Other: Placebo

Placebo Arm

PLACEBO COMPARATOR

Each subject will be dispensed with two nasal spray device labelled as Device A and Device B containing only placebo. Subject's on their own or with assistance from parent/guardian will administer one intranasal spray of placebo, from Device A and Device B, once daily into each nostril in the morning for 4 Weeks.

Other: Placebo

Interventions

FFNS DRUG

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.

FFNS 110 mcg Arm; FFNS 55 mcg Arm

Placebo OTHER

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.

FFNS 110 mcg Arm; FFNS 55 mcg Arm; Placebo Arm

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (16)

GSK Investigational Site

Xiamen, Fujian, 361003, China

Location

GSK Investigational Site

Shenzhen, Guangdong, 518038, China

Location

GSK Investigational Site

Changsha, Hunan, 410005, China

Location

GSK Investigational Site

Changsha, Hunan, 410011, China

Location

GSK Investigational Site

Nanjing, Jiangsu, 210029, China

Location

GSK Investigational Site

Taiyuan, Shanxi, 030016, China

Location

GSK Investigational Site

Wenzhou, Zhejiang, 323027, China

Location

GSK Investigational Site

Beijing, 100034, China

Location

GSK Investigational Site

Beijing, China

Location

GSK Investigational Site

Changsha, China

Location

GSK Investigational Site

Chongqing, 400014, China

Location

GSK Investigational Site

Fuzhou, 350025, China

Location

GSK Investigational Site

Hangzhou, 310052, China

Location

GSK Investigational Site

Shanghai, 200040, China

Location

GSK Investigational Site

Shanghai, 200092, China

Location

GSK Investigational Site

Shanghai, 200127, China

Location

Related Publications (1)

• Zhang Y, Wei P, Chen B, Li X, Luo X, Chen X, Xiang M, Li L, Zhao S, Xiao X, Yang X, Chen J, Fu Y, Xiao S, Liu H, Cheng L, Yao H. Intranasal fluticasone furoate in pediatric allergic rhinitis: randomized controlled study. Pediatr Res. 2021 May;89(7):1832-1839. doi: 10.1038/s41390-020-01180-0. Epub 2020 Oct 2.

  PMID: 33007780 BACKGROUND

MeSH Terms

Conditions

Rhinitis; Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: April 23, 2015
• Study Start: September 30, 2015
• Primary Completion: October 25, 2017
• Study Completion: October 25, 2017
• Last Updated: January 11, 2021
• Results First Posted: February 6, 2019

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

CN (16)