To Evaluate Adenosine Monophosphate and Allergen Challenge in Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
NCT00679250
First received: May 14, 2008
Last updated: May 15, 2008
Last verified: May 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Investigators
Principal Investigator: Arun Nair, MRCP University of Dundee
  More Information

Publications:

Responsible Party: Dr Arun Nair, University of Dundee
ClinicalTrials.gov Identifier: NCT00679250     History of Changes
Other Study ID Numbers: GRAY09, 2004-000683-27
Study First Received: May 14, 2008
Last Updated: May 15, 2008
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

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Adenosine
Levocetirizine
Cetirizine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents

ClinicalTrials.gov processed this record on July 31, 2014