Theophylline in Rhinitis

NCT01132781 | Completed Phase 2

• 2 other identifiers: 2007ENT032007-004642-32
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rhinosinusitis; Asthma; Allergic Rhinitis

Keywords

rhinosinusitis; asthma; allergic rhinitis; theophylline

Outcome Measures

Primary Outcomes (1)

• Difference in total nasal symptom score

  The primary endpoint will be the difference in total nasal symptom score between active and placebo treatment periods measured at the clinic

  18 weeks

Secondary Outcomes (9)

• The difference in domiciliary average total nasal symptom score

  18 weeks

• The difference in nasal peak inspiratory flow at clinic visit

  18 weeks

• The difference in domiciliary nasal peak inspiratory flow

  18 weeks

• The difference in Sino-Nasal Outcomes Test (SNOT) -22 questionnaire

  18 weeks

• Secondary Analysis

  18 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

200mg twice daily of placebo drug

Drug: Placebo (Placebo Group)

200mg theophylline

ACTIVE COMPARATOR

200mg twice daily of slow release theophylline

Drug: Theophylline (Intervention Group)

Interventions

Theophylline (Intervention Group) DRUG

200 mg twice daily of slow release theophylline

200mg theophylline

Placebo (Placebo Group) DRUG

200 mg twice daily of placebo drug

Placebo

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of East Anglia: lead
• Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK): collaborator

Study Sites (1)

University of East Anglia

Norwich, Norfolk, NR47TJ, United Kingdom

Location

MeSH Terms

Conditions

Rhinosinusitis; Asthma; Rhinitis, Allergic

Interventions

Theophylline

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Andrew M Wilson

  University of East Anglia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 28, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 23, 2012

Record last verified: 2012-08

Locations

GB (1)