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To Evaluate Adenosine Monophosphate and Allergen Challenge in Allergic Rhinitis

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
levocetirizine
placebo to levocetirizine
Sponsored by
Brian J Lipworth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring allergic rhinitis, levocetirizine, nasal provocation testing, nasal allergen challenge, nasal adenosine monophosphate challenge

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ninewells Hospital and Medical School (Tayside NHS Trust, University of Dundee)
  • Perth Royal Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Levocetirizine

placebo

Arm Description

Active drug

placebo to levocetirizine

Outcomes

Primary Outcome Measures

Provocative concentration of AMP or Allergen required to cause a 20% drop in Peak Nasal Inspiratory Flow.

Secondary Outcome Measures

Recovery Time Profile after nasal AMP and Allergen challenge

Full Information

First Posted
May 14, 2008
Last Updated
April 10, 2019
Sponsor
Brian J Lipworth
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1. Study Identification

Unique Protocol Identification Number
NCT00679250
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Brian J Lipworth

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
allergic rhinitis, levocetirizine, nasal provocation testing, nasal allergen challenge, nasal adenosine monophosphate challenge

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levocetirizine
Arm Type
Experimental
Arm Description
Active drug
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo to levocetirizine
Intervention Type
Drug
Intervention Name(s)
levocetirizine
Intervention Description
5 mg once nightly before visit
Intervention Type
Drug
Intervention Name(s)
placebo to levocetirizine
Intervention Description
1 tablet once nightly before visit
Primary Outcome Measure Information:
Title
Provocative concentration of AMP or Allergen required to cause a 20% drop in Peak Nasal Inspiratory Flow.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Recovery Time Profile after nasal AMP and Allergen challenge
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arun Nair, MRCP
Organizational Affiliation
University of Dundee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ninewells Hospital and Medical School (Tayside NHS Trust, University of Dundee)
City
Dundee
State/Province
Angus
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Perth Royal Infirmary
City
Perth
State/Province
Perthshire
ZIP/Postal Code
PH1 1NX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
12789212
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.
Results Reference
background
PubMed Identifier
11707753
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.
Results Reference
background
PubMed Identifier
11576078
Citation
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. doi: 10.1034/j.1398-9995.2001.00204.x.
Results Reference
background
PubMed Identifier
11284803
Citation
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. doi: 10.1034/j.1398-9995.2001.00775.x.
Results Reference
background
PubMed Identifier
15206990
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.
Results Reference
background
PubMed Identifier
11520718
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.
Results Reference
background
PubMed Identifier
12680883
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.
Results Reference
background
PubMed Identifier
19187327
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.
Results Reference
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To Evaluate Adenosine Monophosphate and Allergen Challenge in Allergic Rhinitis

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