Official Title: “A Placebo Controlled Trial to Evaluate The Effects of Levocetirizine on Nasal Allergen Challenge And Adenosine Monophosphate Challenge In Patients With Intermittent and Persistent Allergic Rhinitis”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: December 2006

Intervention(s) in this Clinical Trial

• Drug: levocetirizine
  • 5 mg once nightly before visit
• Drug: placebo to levocetirizine
  • 1 tablet once nightly before visit

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Levocetirizine
  • Active drug
• Placebo Comparator: placebo
  • placebo to levocetirizine

Primary Measures

• Provocative concentration of AMP or Allergen required to cause a 20% drop in Peak Nasal Inspiratory Flow.
  • Time Frame: 1 hour
    Safety Issue?: No

Secondary Measures

• Recovery Time Profile after nasal AMP and Allergen challenge
  • Time Frame: 1 hour
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Dundee

Overall Clinical Trial Officials and Contacts

Arun Nair, MRCP Principal Investigator University of Dundee  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00679250

Study ID Number: GRAY09

ClinicalTrials.gov Identifier: NCT00679250

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency