Phase 3
N=261
Study FFR116364, a Placebo-controlled Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis
Rhinitis, Allergic, Perennial
Bottom Line
View on ClinicalTrials.gov: NCT01630135 ↗Enrolled (actual)
261
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period — -1.98; -0.89 Scores on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fluticasone furoate (Drug); Placebo (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period |
-1.98; -0.89 | <0.001 sig |
| SECONDARY Mean Change From Baseline in 3TNSS at Week 1 and Week 2 |
-1.60; -0.70; -2.38; -1.10 | — |
| SECONDARY Mean Percent Change From Baseline in 3TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 |
-39.76; -17.74; -31.96; -13.89; -47.89; -21.95 | — |
| SECONDARY Mean Change From Baseline in 3TNSS at the Indicated Days |
-0.71; -0.52; -1.33; -0.41; -1.53; -0.61 | — |
| SECONDARY Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, at Week 1, and at Week 2 |
-2.40; -1.01; -1.94; -0.74; -2.89; -1.29 | — |
| SECONDARY Mean Percent Change From Baseline in the 4TNSS Over the Entire Treatment Period, at Week 1, and at Week 2 |
-40.42; -16.09; -32.55; -11.54; -48.58; -20.92 | — |
| SECONDARY Mean Change From Baseline in Rhinorrhea, Nasal Congestion, Sneezing, and Nasal Itching Over the Entire Treatment Period (ETP), at Week 1, and at Week 2 |
-0.69; -0.31; -0.55; -0.23; -0.85; -0.40 | — |
| SECONDARY Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, at Week 1, and at Week 2 |
-0.46; -0.32; -0.31; -0.22; -0.61; -0.39 | — |
| SECONDARY Mean Change From Baseline (BL) in the Total Ocular Symptom Score (TOSS) for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 |
-0.77; -0.47; -0.56; -0.35; -0.99; -0.56 | — |
| SECONDARY Mean Percent Change From Baseline (BL) in the TOSS Over the Entire Treatment Period, at Week 1, and at Week 2 |
-20.97; 1.57; -9.20; 5.37; -33.52; -1.70 | — |
| SECONDARY Mean Percent Change From Baseline (BL) in the TOSS for the Baseline TOSS >0 Over the Entire Treatment Period, at Week 1, and at Week 2 |
-20.97; 1.57; -9.20; 5.37; -33.52; -1.70 | — |
| SECONDARY Mean Change From Baseline in the Individual Ocular Symptom Scores (Eye Itching, Tearing, and Redness) Over the Entire Treatment Period, at Week 1, and at Week 2 |
-0.24; -0.18; -0.15; -0.13; -0.34; -0.23 | — |
| SECONDARY Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, at Week 1, and at Week 2 |
-0.43; -0.13; -0.33; -0.10; -0.53; -0.16 | — |
| SECONDARY Number of Participants With the Indicated Scores for Rhinoscopy Findings (Swelling of Inferior Turbinate Mucosa, Color of Inferior Turbinate Mucosa, Quantity of Nasal Discharge, and Quality of Nasal Discharge) at Baseline, Week 1, and Week 2/EW |
2; 7; 24; 32; 54; 55 | — |
| SECONDARY Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator |
32; 12; 38; 25; 36; 31 | — |
| SECONDARY Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant |
28; 2; 51; 26; 34; 48 | — |
Summary
Efficacy and safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 2 weeks in Japanese paediatric subjects ages 6 to < 15 years with perennial allergic rhinitis will be evaluated compared with placebo.
Eligibility Criteria
Inclusion Criteria
- Informed Consent
- 6 to = 4.0 in the last consecutive 4 days prior to Visit 2.
- Completion of the patient diary on >= 3 days of the last consecutive 4 days prior to Visit 2
Exclusion Criteria
- Has a seasonal pollen as an allergen
- A nose disorder that could affect the assessment of the study medication or eye or nose surgery (within 3 months prior to Visit 1)
- Bacterial or viral infection of upper respiratory tract or eye
- Concurrent disease/abnormalities: Clinically significant uncontrolled disease
- Known hypersensitivity to corticosteroids or any excipients in the investigational product
- Has recent participation in a study and/or exposure to an investigational study drug within 3 months prior to Visit 1
- Use of the following medication and/or its combination drug within the specified time:
Anti-IgE (Within 6 months prior to Visit 1), Immunosuppressive medications or Systemic corticosteroids (Within 8 weeks prior to Visit 1), Topical corticosteroids (Within 4 weeks prior to Visit 1), Immunotherapy or nonspecific allassotherapy which was initiated, discontinued or changed its dose within 4 weeks prior to Visit 1
- Affiliation with Investigator's Site: Relative or employee
- History of alcohol or drug abuse, children in care or in the opinion of the investigator (sub-investigator), inappropriate to be enrolled in the study.
- Average of 3TNSS is >= 8.0 in the last consecutive 4 days prior to Visit 2.
- Bacterial or viral infection of upper respiratory tract or eye during the screening period.
Data sourced from ClinicalTrials.gov (NCT01630135). 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.