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To Evaluate Adenosine Monophosphate and Allergen Challenge in Allergic Rhinitis

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ClinicalTrials.gov Identifier: NCT00679250
Recruitment Status : Completed
First Posted : May 16, 2008
Last Update Posted : May 16, 2008
Information provided by:
University of Dundee

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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: levocetirizine Drug: placebo to levocetirizine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2005
Primary Completion Date : December 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Levocetirizine
Active drug
Drug: levocetirizine
5 mg once nightly before visit
Placebo Comparator: placebo
placebo to levocetirizine
Drug: placebo to levocetirizine
1 tablet once nightly before visit

Primary Outcome Measures :
  1. Provocative concentration of AMP or Allergen required to cause a 20% drop in Peak Nasal Inspiratory Flow. [ Time Frame: 1 hour ]

Secondary Outcome Measures :
  1. Recovery Time Profile after nasal AMP and Allergen challenge [ Time Frame: 1 hour ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00679250

United Kingdom
Ninewells Hospital and Medical School (Tayside NHS Trust, University of Dundee)
Dundee, Angus, United Kingdom, DD1 9SY
Perth Royal Infirmary
Perth, Perthshire, United Kingdom, PH1 1NX
Sponsors and Collaborators
University of Dundee
Principal Investigator: Arun Nair, MRCP University of Dundee

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Arun Nair, University of Dundee
ClinicalTrials.gov Identifier: NCT00679250     History of Changes
Other Study ID Numbers: GRAY09
First Posted: May 16, 2008    Key Record Dates
Last Update Posted: May 16, 2008
Last Verified: May 2008

Keywords provided by University of Dundee:
allergic rhinitis
nasal provocation testing
nasal allergen challenge
nasal adenosine monophosphate challenge

Additional relevant MeSH terms:
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Anti-Allergic Agents