Intranasal SB-705498 in Allergic Rhinitis (AR) Patients

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-14

Study Completion Date

2011-07-07

Brief Summary

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This study is designed to look at the affect of SB-705498 on allergic rhinitis symptoms induced by an allergen chamber challenge.

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Detailed Description

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Conditions

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Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SB-705498

Experimental

Group Type EXPERIMENTAL

SB-705498

Intervention Type DRUG

12mg intranasal

Fluticasone Propionate

Active Comparator

Group Type ACTIVE_COMPARATOR

FP

Intervention Type DRUG

200ug intranasal

Placebo

Placebo Comparator

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo intranasal

SB-705498+FP

Experimental

Group Type EXPERIMENTAL

SB-705498

Intervention Type DRUG

12mg intranasal

FP

Intervention Type DRUG

200ug intranasal

Interventions

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SB-705498

12mg intranasal

Intervention Type DRUG

FP

200ug intranasal

Intervention Type DRUG

placebo

placebo intranasal

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. TNSS score of \>=4 following screening allergen challenge chamber.
3. Positive skin prick test for seasonal pollen
4. Positive RAST for seasonal pollen
5. Healthy as determined by responsible physician with the exception of mild asthma and AR
6. Male or female between 18 and 65 years of age inclusive.
7. 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 \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 MlU/ml and estradiol \< 40 pg/ml (\<147 pmol/L) is confirmatory\].
* Child-bearing potential and agrees to use one of the contraception methods listed as instructed. Female subjects must agree to use contraception until 84 days post-last treatment administration.
8. Male subjects with female partners of child-bearing potential must agree to use one contraception as instructed. This must be followed from the time of the first dose of study medication until 84 days post-last treatment administration.
9. Body weight ≥ 50 kg (males) and ≥45kg (females) and BMI within the range 19 - 29.9 kg/m2 (inclusive).
10. Screening pre-challenge FEV1 greater than or equal to 80% and baselines FEV1/FVC greater than or equal to 70% of predicted value.
11. Capable of giving written informed consent.
12. Average QTcB, \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block.
13. AST and ALT \< 2xULN; alkaline phosphatase and bilirubin less than or equal to 1.5xULN

Exclusion Criteria

1. Nasal abnormalities likely to affect the outcome of the study,
2. History of frequent nosebleeds.
3. Respiratory disease other than mild asthma
4. A positive pre-study Hepatitis B or Hepatitis C result within 3 months of screening
5. Current or chronic history of liver disease, or known hepatic or biliary abnormalities
6. Positive pre-study drug/alcohol/smoking screen.
7. A positive test for HIV antibody.
8. History of regular alcohol consumption within 6 months of the study defined as:

• An average weekly intake of \>14 drinks for males or \>7 drinks for females.
9. 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.
10. Exposure to more than four new chemical entities within 12 months prior to D1.
11. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days prior to the first dose of study medication.
12. History of sensitivity to any of the study medications, or components
13. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
14. Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
15. Lactating females.
16. Subject is mentally or legally incapacitated.
17. Urine cotinine levels indicative of smoking

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Vienna, , Austria

Site Status

Countries

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Austria

References

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Bareille P, Murdoch RD, Denyer J, Bentley J, Smart K, Yarnall K, Zieglmayer P, Zieglmayer R, Lemell P, Horak F. The effects of a TRPV1 antagonist, SB-705498, in the treatment of seasonal allergic rhinitis. Int J Clin Pharmacol Ther. 2013 Jul;51(7):576-84. doi: 10.5414/CP201890.

Reference Type BACKGROUND

PMID: 23735181 (View on PubMed)

Study Documents

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