Clinical trial NCT00679250: To Evaluate Adenosine Monophosphate and Allergen Challenge in Allergic Rhinitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Keywords: allergic rhinitis
levocetirizine
nasal provocation testing
nasal allergen challenge
nasal adenosine monophosphate challenge
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2008-05-16
Enrollment: 25
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Provocative concentration of AMP or Allergen required to cause a 20% drop in Peak Nasal Inspiratory Flow.
timeFrame: 1 hour
Secondary outcomes:
measure: Recovery Time Profile after nasal AMP and Allergen challenge
timeFrame: 1 hour
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School (Tayside NHS Trust, University of Dundee)
state: Angus
city: Perth
country: United Kingdom
facility: Perth Royal Infirmary
state: Perthshire
Study officials:
affiliation: University of Dundee
name: Arun Nair, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Togias A. Rhinitis and asthma: evidence for respiratory system integration. J Allergy Clin Immunol. 2003 Jun;111(6):1171-83; quiz 1184. doi: 10.1067/mai.2003.1592.
citation: Bousquet J, Van Cauwenberge P, Khaltaev N; Aria Workshop Group; World Health Organization. Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol. 2001 Nov;108(5 Suppl):S147-334. doi: 10.1067/mai.2001.118891. No abstract available.
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citation: Lee DK, Gray RD, Wilson AM, Robb FM, Soutar PC, Lipworth BJ. Single and short-term dosing effects of levocetirizine on adenosine monophosphate bronchoprovocation in atopic asthma. Br J Clin Pharmacol. 2004 Jul;58(1):34-9. doi: 10.1111/j.1365-2125.2004.02110.x.
citation: Terada N, Hamano N, Kim WJ, Hirai K, Nakajima T, Yamada H, Kawasaki H, Yamashita T, Kishi H, Nomura T, Numata T, Yoshie O, Konno A. The kinetics of allergen-induced eotaxin level in nasal lavage fluid: its key role in eosinophil recruitment in nasal mucosa. Am J Respir Crit Care Med. 2001 Aug 15;164(4):575-9. doi: 10.1164/ajrccm.164.4.2009046.
citation: Wilson AM, Sims EJ, Orr LC, Robb F, Lipworth BJ. An evaluation of short-term corticosteroid response in perennial allergic rhinitis using histamine and adenosine monophosphate nasal challenge. Br J Clin Pharmacol. 2003 Apr;55(4):354-9. doi: 10.1046/j.1365-2125.2003.01776.x.
citation: Vaidyanathan S, Nair A, Barnes ML, Meldrum K, Lipworth BJ. Effect of levocetirizine on nasal provocation testing with adenosine monophosphate compared with allergen challenge in allergic rhinitis. Clin Exp Allergy. 2009 Mar;39(3):409-16. doi: 10.1111/j.1365-2222.2008.03166.x.