Rhinitis MedDRA version: 9.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis
Conditions
Interventions
Trade Name: Uniphyllin Continus
Product Name: Uniphyllin Continus
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Sponsors
University of East Anglia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Males or females, aged between 16 and 65 years. • Weight between 50 and 150 Kg. • Smokers, non-smokers or ex-smokers • Chronic rhinosinusitis as defined as 2 or more symptoms of nasal blockage/congestion, discharge, facial pain or reduction in smell for more than 12 weeks. • A positive skin prick test or RAST to a perennial allergen • Patients with a seasonal component to their symptoms can be enrolled out with the relevant pollen season. • Patients must be receiving intranasal corticosteroids • Patients will be permitted to receive inhaled short and long acting beta2 agonists or anti-cholinergic drugs, inhaled corticosteroids (up to a dose of 2mg per day BPD equivalent), oral montelukast or oral antihistamines. • Able to provide written informed consent. 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: • Significant medical, surgical or psychiatric disease that would affect the results of the study in the opinion of the investigator. • Women who are pregnant or breast feeding • Patients with previous cardiac problems or significant renal or hepatic impairment • Upper respiratory tract infection in the last month as defined by yellow or green nasal discharge and increase in the usual nasal symptoms. • Patients consuming more than the recommended amount of alcohol (14 units per week for women and 21 units per week for men) • Inhaled corticosteroids at a dose greater than 2mg beclomethasone dipropionate (BDP) equivalent or oral corticosteroids or oral zafirlukast • Currently receiving oral theophyllines. • Previous adverse effects to oral or intravenous theophylline. • Currently any medication known to interact with theophylline including o Allopurinol o Macrolide, quinolone or isoniazid o Fluvoxamine o Carbamazepine, phenytoin o Fluconazole or itraconazole o Barbiturates o Lithium o Oestrogens o Cimetidine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of 200mg twice daily oral theophylline in addition to inhaled corticosteroid therapy in patients with allergic rhinitis versus placebo in terms of nasal symptoms, nasal function, nasal scraping and histone deacetlyase activity;Secondary Objective: ;Primary end point(s): The primary endpoint will be the difference in total nasal symptom score between active and placebo treatment periods measured at the clinic | — |
Countries
United Kingdom
Outcome results
None listed