To Evaluate Adenosine Monophosphate and Allergen Challenge in Allergic Rhinitis

Brian J Lipworth

Status and phase

Completed

Phase 4

Conditions

Allergic Rhinitis

Treatments

Drug: placebo to levocetirizine

Drug: levocetirizine

Study type

Interventional

Funder types

Other

Identifiers

NCT00679250

2004-000683-27

GRAY09

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

16 to 75 years old

Volunteers

No Healthy Volunteers

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