Theophylline in Rhinitis

NCT01132781 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2012-08-23

No results posted yet for this study

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

Interventions

DRUG

Theophylline (Intervention Group)

200 mg twice daily of slow release theophylline

DRUG

Placebo (Placebo Group)

200 mg twice daily of placebo drug

Sponsors & Collaborators

  • Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

    collaborator OTHER
  • University of East Anglia

    lead OTHER

Principal Investigators

  • Andrew M Wilson · University of East Anglia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01132781 on ClinicalTrials.gov