Theophylline in Rhinitis

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Allergic rhinitis and asthma are common respiratory diseases, which often coexist. The prevalence of allergic rhinitis in subjects with asthma is up to 80%, and the prevalence of asthma is 3-5 times greater in subjects with rhinitis than healthy controls. The mechanisms of the allergen response in both diseases are parallel to each other, with similar mediator and cellular responses to similar allergens. These observations have led to the suggestion that both diseases are different expressions of one airway disease.We wish to evaluate the effect of low dose theophylline in patients with asthma, given its effects as subtherapeutic concentrations and the propensity to develop adverse events at higher doses.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of East Anglia
• Collaborator: Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
• Treatments: Theophylline

Criteria

Inclusion Criteria:

• Males or females, aged between 16 and 65 years.

• Weight between 50 and 150 Kg.

• Smokers, non-smokers or ex-smoker.

• 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.

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

• Allopurinol

• Macrolide, quinolone or isoniazid

• Fluvoxamine

• Carbamazepine, phenytoin

• Fluconazole or itraconazole

• Barbiturates

• Lithium

• Oestrogens

• Cimetidine