Phase 3
N=61
Study FFR116365, an Open-label Study of GW685698X in Paediatric Subjects With Perennial Allergic Rhinitis
Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT01622231 ↗Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) — 41; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fluticasone furoate (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) |
41; 0 | — |
| SECONDARY Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophil Count at Week 4 and Week 12/Early Withdrawal |
-0.08; -0.12; -0.29; -1.38; -1.22; -1.77 | — |
| SECONDARY Change From Baseline in Hemoglobin at Week 4 and Week 12/Early Withdrawal |
-1.9; 0.1 | — |
| SECONDARY Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Week 4 and Week 12/Early Withdrawal |
-0.4; -2.9; -0.45; -0.00 | — |
| SECONDARY Change From Baseline in Red Blood Cell (RBC) Count at Week 4 and Week 12/Early Withdrawal |
-0.081; -0.039 | — |
| SECONDARY Change From Baseline in Hematocrit at Week 4 and Week 12/Early Withdrawal |
-0.0061; -0.0062 | — |
| SECONDARY Change From Baseline in Albumin and Total Protein at Week 4 and Week 12/Early Withdrawal |
-1.4; -0.8; -1.8; -0.9 | — |
| SECONDARY Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyltransferase (GGT) at Week 4 and Week 12/Early Withdrawal |
-49.9; 88.5; 0.7; 0.4; -0.3; 0.2 | — |
| SECONDARY Change From Baseline in Direct Bilirubin, Total Bilirubin, and Creatinine at Week 4 and Week 12/Early Withdrawal |
0.114; -0.028; 0.370; -0.533; -1.6649; -0.5797 | — |
| SECONDARY Change From Baseline in Calcium, Chloride, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal |
-0.0541; -0.0372; 1.3; 1.1; -0.13; -0.06 | — |
| SECONDARY Mean Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 |
-2.2; -1.6; -2.5; -2.4; -2.0 | — |
| SECONDARY Mean Percent Change From Baseline in the 3 Total Nasal Symptom Score (3TNSS) Over the Entire Treatment Period, Week 1to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 |
-46.9; -31.6; -53.2; -50.9; -40.7 | — |
| SECONDARY Mean Change From Baseline (BL) in Daily Variation of the 3 Total Nasal Symptom Score (3TNSS) |
-0.5; -0.8; -0.9; -1.3; -1.4; -1.3 | — |
| SECONDARY Mean Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 |
-2.6; -1.8; -2.9; -2.8; -2.3 | — |
| SECONDARY Mean Percent Change From Baseline in the 4 Total Nasal Symptom Score (4TNSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 |
-47.1; -31.3; -52.8; -51.3; -42.0 | — |
| SECONDARY Mean Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 |
-0.2; -0.1; -0.1; -0.2; -0.3 | — |
| SECONDARY Mean Percent Change From Baseline in the Total Ocular Symptom Score (TOSS) Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 |
7.1; 4.6; 17.5; 29.0; -22.5 | — |
| SECONDARY Mean Change From Baseline in Sneezing, Rhinorrhea, Nasal Congestion, and Nasal Itching Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 |
-0.7; -0.5; -0.8; -0.7; -0.6; -0.8 | — |
| SECONDARY Mean Change From Baseline in Eye Itching, Tearing, and Redness Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 |
-0.2; -0.1; -0.1; -0.2; -0.2; 0.0 | — |
| SECONDARY Mean Change From Baseline in the Score of Troubles With Daily Life Over the Entire Treatment Period, Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12 |
-0.5; -0.3; -0.5; -0.6; -0.4 | — |
| 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) |
3; 9; 35; 14; 15; 21 | — |
| SECONDARY Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Investigator |
25; 28; 3; 5; 0; 0 | — |
| SECONDARY Number of Participants With the Indicated Overall Response to Therapy, as Assessed by the Participant's Parent/Guardian or the Participant |
13; 31; 12; 4; 1; 0 | — |
| SECONDARY Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=2 to <6 Years |
17; 2; 0; 0 | — |
| SECONDARY Number of Participants With the Indicated Plasma Concentration of GW685698X for Participants Aged >=6 to <15 Years |
37; 2; 1; 0 | — |
Summary
Safety of GW685698X (55 µg/day, q.d.) nasal spray over a period of 12 weeks in Japanese paediatric subjects ages 2 to < 15 years with perennial allergic rhinitis will be evaluated. And secondarily, efficacy and systemic exposure of GW685698X (55 µg/day, q.d.) nasal spray over a period of 12 weeks in Japanese paediatric subjects ages 2 to < 15 years with perennial allergic rhinitis will also be evaluated.
Eligibility Criteria
Inclusion Criteria
- Informed Consent
- 2 to = 3.0 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.
- Bacterial or viral infection of upper respiratory tract or eye during the screening period.
Data sourced from ClinicalTrials.gov (NCT01622231). 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.