Study FFR116365, an open-label study of GW685698X in paediatric subjects with perennial allergic rhinitis
Trial overview
Number of participants with any non-serious adverse event (AE) and any serious adverse event (SAE)
Timeframe: From the start of study treatment (Visit 2) until follow-up contact (Visit 6) (up to 13 weeks)
Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, and total neutrophil count at Week 4 and Week 12/Early Withdrawal
Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal
Change from Baseline in hemoglobin at Week 4 and Week 12/Early Withdrawal
Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal
Change from Baseline in platelet count and white blood cell (WBC) count at Week 4 and Week 12/Early Withdrawal
Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal
Change from Baseline in red blood cell (RBC) count at Week 4 and Week 12/Early Withdrawal
Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal
Change from Baseline in hematocrit at Week 4 and Week 12/Early Withdrawal
Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal
Change from Baseline in albumin and total protein at Week 4 and Week 12/Early Withdrawal
Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal
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
Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal
Change from Baseline in direct bilirubin, total bilirubin, and creatinine at Week 4 and Week 12/Early Withdrawal
Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal
Change from Baseline in calcium, chloride, potassium, sodium, and urea/blood urea nitrogen (BUN) at Week 4 and Week 12/Early Withdrawal
Timeframe: Baseline, Week 4, and Week 12/Early Withdrawal
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
Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
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
Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
Mean change from Baseline (BL) in daily variation of the 3 Total Nasal Symptom Score (3TNSS)
Timeframe: Baseline, Day 1 to Day 84
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
Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
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
Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
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
Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
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
Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
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
Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
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
Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
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
Timeframe: Baseline through the entire treatment period (12 weeks), Week 1 to 2, Week 3 to 4, Week 7 to 8, and Week 11 to 12
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)
Timeframe: Baseline, Week 4, Week 8, and Week 12/early withdrawal
Number of participants with the indicated overall response to therapy, as assessed by the investigator
Timeframe: Week 12/early withdrawal
Number of participants with the indicated overall response to therapy, as assessed by the participant’s parent/guardian or the participant
Timeframe: Week 12/early withdrawal
Number of participants with the indicated plasma concentration of GW685698X for participants aged >=2 to <6 years
Timeframe: Between 0.5 to 2 hours after final dosing at Week 12 (Visit 5)
Number of participants with the indicated plasma concentration of GW685698X for participants aged >=6 to <15 years
Timeframe: Between 0.5 to 2 hours after final dosing at Week 12 (Visit 5)
Participation criteria
- Informed Consent
- 2 to <15 years of age, male or eligible female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control), outpatient
- 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)
- Informed Consent
- 2 to <15 years of age, male or eligible female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control), outpatient
- Diagnosis of perennial allergic rhinitis: A positive test response to house dust and/or dust mites on serum antigen-specific IgE antibody test at Visit 1. Six months or more clinical history of perennial allergic rhinitis. A positive test result on nasal eosinophil count at Visit 1/1A.
- Either subject's parent/guardian who signed ICF or subject is able to complete assessments on the patient diary through the study.
- ALT < 2xULN; alkaline phosphatase and bilirubin <= 1.5xULN
- Average of 3TNSS is >= 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
- 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.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.