To Evaluate Adenosine Monophosphate and Allergen Challenge in Allergic Rhinitis - Full Text View

Sponsored by:	University of Dundee
Information provided by:	University of Dundee
ClinicalTrials.gov Identifier:	NCT00679250

Purpose

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.

Condition	Intervention	Phase
Allergic Rhinitis	Drug: levocetirizine Drug: placebo to levocetirizine	Phase IV

Drug Information available for: Levocetirizine dihydrochloride Levocetirizine Adenosine Adenosine monophosphate

U.S. FDA Resources

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

Further study details as provided by University of Dundee:

Primary Outcome Measures:

Provocative concentration of AMP or Allergen required to cause a 20% drop in Peak Nasal Inspiratory Flow. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Recovery Time Profile after nasal AMP and Allergen challenge [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Enrollment:	25
Study Start Date:	November 2005
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Levocetirizine: Experimental Active drug	Drug: levocetirizine 5 mg once nightly before visit
placebo: Placebo Comparator placebo to levocetirizine	Drug: placebo to levocetirizine 1 tablet once nightly before visit

Eligibility

Ages Eligible for Study:	16 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679250

Locations

United Kingdom, Angus
Ninewells Hospital and Medical School (Tayside NHS Trust, University of Dundee)
Dundee, Angus, United Kingdom, DD1 9SY
United Kingdom, Perthshire
Perth Royal Infirmary
Perth, Perthshire, United Kingdom, PH1 1NX

Sponsors and Collaborators

University of Dundee

Investigators

Principal Investigator:

Arun Nair, MRCP

University of Dundee

More Information

Publications:

Togias A. Rhinitis and asthma: evidence for respiratory system integration. J Allergy Clin Immunol. 2003 Jun;111(6):1171-83; quiz 1184. Review.

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. Review. No abstract available.

Clough GF, Boutsiouki P, Church MK. Comparison of the effects of levocetirizine and loratadine on histamine-induced wheal, flare, and itch in human skin. Allergy. 2001 Oct;56(10):985-8.

Wang DY, Hanotte F, De Vos C, Clement P. Effect of cetirizine, levocetirizine, and dextrocetirizine on histamine-induced nasal response in healthy adult volunteers. Allergy. 2001 Apr;56(4):339-43.

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.

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.

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.

Responsible Party:	University of Dundee ( Dr Arun Nair )
Study ID Numbers:	GRAY09, 2004-000683-27
Study First Received:	May 14, 2008
Last Updated:	May 15, 2008
ClinicalTrials.gov Identifier:	NCT00679250
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Dundee:

allergic rhinitis
levocetirizine
nasal provocation testing
nasal allergen challenge
nasal adenosine monophosphate challenge

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Levocetirizine
Histamine phosphate

Rhinitis
Cetirizine
Adenosine
Histamine

Additional relevant MeSH terms:

Neurotransmitter Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine Agents
Anti-Allergic Agents
Cardiovascular Agents
Nose Diseases
Pharmacologic Actions

Histamine Antagonists
Sensory System Agents
Therapeutic Uses
Histamine H1 Antagonists
Analgesics
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Histamine H1 Antagonists, Non-Sedating
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009