A Study to Validate Key Therapeutic Targets and Biomarkers during Allergen Exposure in Subjects with Allergic Rhinitis

Phase 1

• Conditions: Seasonal allergic rhinitis

• Registration Number: EUCTR2004-002872-41-GB
• Lead Sponsor: GlaxoSmithKline Research & Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-07-29
• Study Completion: 2007-05-06
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

•Males or females aged between 18 and 65 years inclusive
•Female subjects of childbearing potential must be using effective forms of contraception (i.e. abstinence, oral contraceptives, Norplant*, documented placement of intrauterine device (IUD) with failure rate of less than 1%, a diaphragm with spermicide, a condom and diaphragm with spermicide or Depo-Provera*) for at least one month prior to screening and throughout the study period.
•Subjects with a known history of SAR with a clinically significant positive skin prick test/RAST to any of 6 common allergens
•No signs or symptoms of rhinitis outside of the relevant airborne allergen season(s)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•As a result of medical interview, physical examination or screening investigation the physician responsible considers the subject unfit for the study
•Subject is female who is pregnant or lactating
•History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments
•History of abnormal bruising or bleeding
•Symptoms of rhinitis at inclusion indicated by total VAS score of >40 for the combined symptoms scores for blockage, rhinorrhoea, sneezing, itching) or a single symptom with a VAS score >20
•Subjects not showing a nasal response to allergen concentration =< 10,000 BU/ml
•Subjects with positive skin prick test for Dust House Mite
•Subjects showing demonstrating hypersensitivity to the vehicle challenge at screening
•Concurrent purulent nasal infection
•Requirement for > 250µg inhaled FP > 500µg inhaled budesonide propionate (BDP; or equivalent) per day as treatment for asthma
•Inability to abstain from all intranasal or oral medication to treat nasal allergy from study visit 1 to the completion of the study including: sodium cromoglycate, anti-histamines, alpha-adrenergic agonists and corticosteroids
•Use of any medications that significantly inhibit the Cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole
•Current smokers or anyone that has regularly smoked over the last 6 months
•Female subjects who are unwilling or unable to use an appropriate method of contraception

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified