Seasonal allergic rhinitis
Conditions
Interventions
Product Name: Fluticasone Propionate 0.05%w/w Aqueous Nasal Spray
Pharmaceutical Form: Nasal spray, suspension
Other descriptive name: Fluticasone Propionate
Concentration unit: % (W/W) percent weight
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 = 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To examine the change in expression of key allergy targets in the nose following exposure to allergen. •To evaluate the effect of intranasal corticosteroids treatment on the change in target expression following allergen challenge. •Identify biomarkers associated with clinical response to allergen and corticosteroids. ;Secondary Objective: •Examine the relationship between changes in target expression and clinical measures of allergen response. •Identify nasal and systemic biomarkers associated with changes in target expression and with the clinical response to allergen and corticosteroids. •Evaluate nasal pathology following allergen challenge and corticosteroid treatment ;Primary end point(s): Target Expression: •Assessment of protein expression by western blotting and/or immunohistochemistry in nasal biopsy tissue •Assessment of protein expression in nasal lavage fluid by ELISA and/or chemiluminescent assay. • Assessment of mRNA expression by Taqman RT-PCR and/or LCMD in nasal biopsy tissue Clinical Measures: •Symptom scores (total nasal symptom score and components) •Measures of nasal resistance: acoustic rhinomanometry, nasal peak inspiratory flow (PnIF) •Nasal nitric oxide •Clinical events Biomarkers: •Inflammatory cell counts in nasal lavage fluid •Inflammatory mediator (e.g. histamine, prostaglandin-D2, IL-5) expression assessed by western blotting and/or immunohistochemistry in nasal biopsy tissue •Inflammatory mediator expression in nasal lavage fluid assessed by ELISA and/or chemiluminescent assay •Differential cell counts in whole blood •Inflammatory mediator expression in plasma or in frozen white blood cells assessed by ELISA and/or chemiluminescent assay •Genotyping: where appropriate changes in target/biomarker expression will also be related to polymorphic variation within their corresponding genes | — |
Countries
United Kingdom
Outcome results
None listed