Allergic Rhinitis
Conditions
Keywords
allergic rhinitis, levocetirizine, nasal provocation testing, nasal allergen challenge, nasal adenosine monophosphate challenge
Brief summary
Allergic rhinitis is a common condition characterize by inflammation of the upper airways. Third generation antihistamines have been demonstrated effective in the treatment of this condition. Allergen challenge can be use to assess the effects of drugs in allergic rhinitis, adenosine monophosphate may also be used as a means to investigate these effects but as yet its effects have yet to be compared to allergen challenge. We intend to compare the effects of levocetirizine at a single dose of 5mg on allergen and AMP challenge compared to placebo in a double blind cross-over study. The study will include 20 patients with allergic rhinitis. Each patient will have allergen and AMP challenge on placebo and active treatment. The primary outcome variable will be the change in concentration of AMP/Allergen required to produce a 20% drop in nasal flow as manifest by peak nasal inspiratory flow. A 1 doubling dose change in concentration of challenge medium to cause a 20% drop in nasal flow will be deemed significant. We will also measure time to recovery after both challenges. AMP challenge is a safe alternative to allergen challenge and does not have the risk of anaphylaxis.
Interventions
DRUGplacebo to levocetirizine
1 tablet once nightly before visit
DRUGlevocetirizine
5 mg once nightly before visit
Sponsors
Brian J Lipworth
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female 16-75 * Patients with persistent rhinitis must be skin prick positive to house dust mite with perennial symptoms * Patients with seasonal rhinitis should be skin prick positive to grass/tree pollen with seasonal symptoms * Concomitant asthma is permitted in those with rhinitis if FEV1 \>60% * No recent exacerbations of asthma or chest infections if asthmatic * Able to perform all of the techniques necessary to carry out challenge testing * Must be compliant to study medication * Must give informed consent
Exclusion criteria
* Male or female outwith the above age range * Negative skin prick testing * Patients with concomitant asthma with FEV1 less than 60% predicted * Patients with asthma with recent chest infection or exacerbation * Pregnant females, those at risk of becoming pregnant or breast feeding. Females must be on adequate contraception for the whole study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Provocative concentration of AMP or Allergen required to cause a 20% drop in Peak Nasal Inspiratory Flow. | 1 hour |
Secondary
| Measure | Time frame |
|---|---|
| Recovery Time Profile after nasal AMP and Allergen challenge | 1 hour |
Countries
United Kingdom
Outcome results
None listed