Intranasal SB-705498 in Non-allergic Rhinitis Patients

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Rhinitis

Treatments

Drug: Placebo

Drug: SB-705498

Study type

Interventional

Funder types

Industry

Identifiers

NCT01439308

111925

Details and patient eligibility

About

This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by capsaicin challenge

Enrollment

40 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

NAR patients
Male or female between 18 and 60 years of age inclusive.
Non-child bearing women or women of child bearing potential if they agree to use contraception as indicated by the protocol
Non-smoker for at least 6 months with a pack history <5 pack years (Pack years = (No. of cigarettes smoked/day/20) x No. of years smoked).
Body weight > 50 kg and body mass index (BMI) within the range 19 - 29.9 kg/m2 (inclusive).
Capable of giving written informed consent.
Available to complete all the required study measurements.
Normal 12-lead ECG at screening.
Subject must demonstrate reactivity to unilateral, intranasal challenge with the selected single dose of capsaicin, defined as development of TSS ≥ 3.
Normal levels of total plasma IgG and negative allergy skin or Rast test to common aeorallergens.
Good general health, apart from NAR, as determined by a responsible physician.

Exclusion criteria

Past medical history of allergic rhinitis or rhinosinusitis.

Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, other nasal malformations.
A history of gastrointestinal, hepatic, renal or multiple cardiovascular risk factors.
Positive pre-study drug/alcohol screen.
Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
A positive test for human immunodeficiency virus (HIV) antibody (if determined by the local standard operating procedures (SOPs)).
History of regular alcohol consumption within 6 months of the study.
Exposure to more than four new chemical entities within 12 months prior to the start of the study.
Participation in a clinical trial with a new molecule entity or any other clinical trial within 4 months of the start of the study.
Use of prescription or non-prescription drugs, as well as of vitamins, herbal and dietary supplements (including St John's Wort) within 2 days prior to each study visit in Part 1 of the study or 14 days prior to the first treatment administration in Part 2 of the study.
Inability to abstain from all intranasal or oral medication to treat nasal symptoms from the first capsaicin challenge to the completion of the study including: sodium cromoglycate, antihistamines, anticholinergics, alpha-adrenergic agonists and corticosteroids
History of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation.
Subjects demonstrating hypersensitivity to the placebo capsaicin challenge at baseline screening.
Donation of blood or blood products in excess of 500mL within a 56 day period prior the start of Part 2 of this study.
Pregnant females as determined by positive serum or urine human chorionic gonadotropin (hCG) test at screening or prior to dosing.
Lactating females.
Unwillingness or inability to follow the procedures outlined in the protocol.
History of sensitivity to heparin or heparin-induced thrombocytopenia.
Nicotine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
For Part 2 only: Subjects with known lactose intolerance.