To Evaluate Adenosine Monophosphate and Allergen Challenge in Allergic Rhinitis

April 10, 2019 updated by: Brian J Lipworth

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Recovery Time Profile after nasal AMP and Allergen challenge
Time Frame: 1 hour
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brian J Lipworth

Investigators

  • Principal Investigator: Arun Nair, MRCP, University of Dundee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (ACTUAL)

December 1, 2006

Study Completion (ACTUAL)

December 1, 2006

Study Registration Dates

First Submitted

May 14, 2008

First Submitted That Met QC Criteria

May 15, 2008

First Posted (ESTIMATE)

May 16, 2008

Study Record Updates

Last Update Posted (ACTUAL)

April 12, 2019

Last Update Submitted That Met QC Criteria

April 10, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRAY09
  • 2004-000683-27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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