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Intranasal SB-705498 in Non-allergic Rhinitis Patients

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-allergic Rhinitis; Rhinitis

Intervention: Placebo (Drug); SB-705498 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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

Clinical Details

Official title: A Randomized, Double Blind, Placebo Controlled Study to Assessthe Effect of Intranasal Single Dose SB-705498 on the Response Tointranasal Capsaicin Challenge in Non-allergic Rhinitis Patients

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Symptom scores and ipsilateral secretion weights

Secondary outcome:

Peak nasal inspiratory flow changes after challenge

Biomarker levels in the nasal samples

Blood levels of drug

Number of subjects with adverse events

Symptom scores and contralateral secretion weights

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

GSK Investigational Site, Amsterdam 1105 AZ, Netherlands
Additional Information

Starting date: December 2009
Last updated: March 22, 2012

Page last updated: August 20, 2015

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