DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



To Evaluate Adenosine Monophosphate and Allergen Challenge in Allergic Rhinitis

Information source: University of Dundee
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Allergic Rhinitis

Intervention: levocetirizine (Drug); placebo to levocetirizine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Dundee

Official(s) and/or principal investigator(s):
Arun Nair, MRCP, Principal Investigator, Affiliation: University of Dundee

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Secondary outcome: Recovery Time Profile after nasal AMP and Allergen challenge

Eligibility

Minimum age: 16 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Ninewells Hospital and Medical School (Tayside NHS Trust, University of Dundee), Dundee, Angus DD1 9SY, United Kingdom

Perth Royal Infirmary, Perth, Perthshire PH1 1NX, United Kingdom

Additional Information

Related publications:

Togias A. Rhinitis and asthma: evidence for respiratory system integration. J Allergy Clin Immunol. 2003 Jun;111(6):1171-83; quiz 1184. Review.

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. Review.

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.

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.

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.

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.

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.

Starting date: November 2005
Last updated: May 15, 2008

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017