Phase 2
N=70
Intranasal SB-705498 in Allergic Rhinitis (AR) Patients
Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT01424397 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Mean Total Nasal Symptom Score (TNSS) and Its Individual Components on Day 8 — 6.53; 3.65; 6.57; 4.14 Score on scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SB-705498 (Drug); FP (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Total Nasal Symptom Score (TNSS) and Its Individual Components on Day 8 |
6.53; 3.65; 6.57; 4.14; 1.80; 1.15 | — |
| SECONDARY Mean TNSS and Its Individual Components From Day 4 to Day 8 |
3.6; 2.4; 3.3; 2.6; 3.6; 2.0 | — |
| SECONDARY Total Nasal Airflow on Day 8 Measured Using Active Anterior Rhinomanometry (AAR) |
306.99; 388.34; 299.68; 379.40 | — |
| SECONDARY Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Following Repeat Doses of SB-705498 or or SB-705498 Matching Placebo |
1.67; 0.99; 1.66; 1.14 | — |
| SECONDARY Area Under Concentration-time Curve (AUC) for SB-705498 on Day 8 |
588.26; 608.84 | — |
| SECONDARY Maximum Observed Concentration (Cmax) for SB-705498 on Day 8 |
145.958; 154.231 | — |
| SECONDARY Number of Participants With Vital Signs of Potential Clinical Importance (PCI) |
2; 0; 0; 0; 2; 1 | — |
| SECONDARY Change From Baseline in ECG Values: Heart Rate |
-0.2; -4.7; -4.8; -2.6 | — |
| SECONDARY Change From Baseline in ECG Values: PR Interval, QRS Duration, QT Interval, QTcB, QTcF |
2.7; -1.2; 4.5; 0.4; 0.8; 2.2 | — |
| SECONDARY Number of Participants With Hematology Parameters of PCI |
7; 9; 2; 4; 0; 0 | — |
| SECONDARY Number of Participants With Clinical Biochemistry Parameters of PCI |
19; 25; 6; 14; 2; 2 | — |
Summary
This study is designed to look at the affect of SB-705498 on allergic rhinitis symptoms induced by an allergen chamber challenge.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of AR, as determined by the presence of rhinitis symptoms that last for several months per year, for more than 1 year and are not attributed to allergy, infections or nasal abnormalities.
- TNSS score of >=4 following screening allergen challenge chamber.
- Positive skin prick test for seasonal pollen
- Positive RAST for seasonal pollen
- Healthy as determined by responsible physician with the exception of mild asthma and AR
- Male or female between 18 and 65 years of age inclusive.
- A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-menopausal females with a \documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol 14 drinks for males or >7 drinks for females.
- The subject has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product prior to D1.
- Exposure to more than four new chemical entities within 12 months prior to D1.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days prior to the first dose of study medication.
- History of sensitivity to any of the study medications, or components
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
- Lactating females.
- Subject is mentally or legally incapacitated.
- Urine cotinine levels indicative of smoking
Data sourced from ClinicalTrials.gov (NCT01424397). 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.