Phase 4
Completed N=358
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)
Rhinitis, Allergic, Perennial and Seasonal · Rhinitis, Allergic
Source: ClinicalTrials.gov NCT02424539 ↗
Enrolled (actual)
358
Serious AEs
0.3%
Results posted
Feb 2019
Primary outcomePrimary: Mean Change From Baseline in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over the First 2 Weeks Treatment Period — -1.95; -3.18; -3.28 Scores on a scale — p=<0.001
◆ Published Evidence
Emerging
16citations · ~3 / year
Intranasal fluticasone furoate in pediatric allergic rhinitis: randomized controlled study.
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.
Linked Publications
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Intranasal fluticasone furoate in pediatric allergic rhinitis: randomized controlled study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over the First 2 Weeks Treatment Period |
-1.95; -3.18; -3.28 | <0.001 sig |
| SECONDARY Number of Participants Showing Response to the Therapy After the First 2 Weeks Treatment on a 7-point Categorical Scale |
13; 38; 51; 30; 48; 33 | <0.001 sig |
| SECONDARY Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 2 Weeks |
-2.32; -4.47; -4.30 | <0.001 sig |
| SECONDARY Mean Change From Baseline Over the First 2 Weeks in the Daily, Reflective Total Ocular Symptoms Score (rTOSS) |
-1.15; -1.24; -1.40 | 0.503 |
| SECONDARY Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 2 Weeks Treatment Period |
12.76; 13.28; 13.43 | 0.048 sig |
| SECONDARY Mean Change From Baseline in Daily rTNSS Over the 4 Weeks Treatment Period |
-2.57; -3.93; -4.03 | <0.001 sig |
| SECONDARY Number of Participants Showing Response to the Therapy After 4 Weeks Treatment on a 7-point Categorical Scale |
22; 59; 63; 31; 34; 34 | <0.001 sig |
| SECONDARY Mean Change From Baseline of Intranasal Finding Score by Anterior Rhinoscopy at the First 4 Weeks |
-3.21; -5.68; -5.48 | <0.001 sig |
| SECONDARY Mean Change From Baseline in the Daily rTOSS Over the 4 Weeks Treatment Period |
-1.41; -1.52; -1.70 | 0.442 |
| SECONDARY Mean Change From Baseline in Rescue Loratadine Use (Mean Rescue-free Days) Over the First 4 Weeks Treatment Period |
23.74; 25.62; 26.41 | 0.004 sig |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs During the Treatment Period |
51; 52; 65; 0; 0; 1 | — |
| SECONDARY Number of Participants With Clinical Chemistry Values Outside the Normal Range |
4; 2; 1; 2; 3; 2 | — |
| SECONDARY Number of Participants With Hematology Values Outside Normal Range |
6; 3; 7; 0; 0; 0 | — |
| SECONDARY Number of Participants With Urinalysis Values Outside Normal Range |
6; 7; 2; 3; 2; 3 | — |
| SECONDARY Number of Participants With Change From Baseline in Nasal Examination |
39; 65; 47; 8; 0; 2 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) |
-1.4; -1.4; -0.1; -1.1; 0.2; 0.2 | — |
| SECONDARY Change From Baseline in Heart Rate |
-0.6; -1.1; -0.4 | — |
| SECONDARY Change From Baseline in Temperature |
-0.06; -0.01; -0.01 | — |
| SECONDARY Change From Baseline in Respiration Rate |
0.0; -0.4; -0.3 | — |
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 =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 450 milliseconds (msec) or QTc > 480 msec in subjects with Bundle Branch Block. The QTc is the QT interval corrected fo
Data sourced from ClinicalTrials.gov (NCT02424539) and the linked publication. 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. Informational only — not medical advice.