To Evaluate Adenosine Monophosphate and Allergen Challenge in Allergic Rhinitis
NCT ID: NCT00679250
Last Updated: 2019-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
25 participants
INTERVENTIONAL
2005-11-30
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Levocetirizine
Active drug
levocetirizine
5 mg once nightly before visit
placebo
placebo to levocetirizine
placebo to levocetirizine
1 tablet once nightly before visit
Interventions
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levocetirizine
5 mg once nightly before visit
placebo to levocetirizine
1 tablet once nightly before visit
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
75 Years
ALL
No
Sponsors
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Brian J Lipworth
OTHER
Responsible Party
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Brian J Lipworth
Professor (Clinical) Airway allergy and COPD
Principal Investigators
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Arun Nair, MRCP
Role: PRINCIPAL_INVESTIGATOR
University of Dundee
Locations
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Ninewells Hospital and Medical School (Tayside NHS Trust, University of Dundee)
Dundee, Angus, United Kingdom
Perth Royal Infirmary
Perth, Perthshire, United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2004-000683-27
Identifier Type: -
Identifier Source: secondary_id
GRAY09
Identifier Type: -
Identifier Source: org_study_id
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