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Phase 2 N=70 Randomized Double-blind Treatment

Intranasal SB-705498 in Allergic Rhinitis (AR) Patients

Rhinitis

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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