Anti-allergic drug testing in an environmental challenge chamber is suitable both in and out of the relevant pollen season

被引:28
作者
Badorrek, Philipp [1 ]
Dick, Melanie [1 ]
Hecker, Hartmut [2 ]
Schaumann, Frank [1 ]
Sousa, Ana R. [3 ]
Murdoch, Robert [3 ]
Hohlfeld, Jens M. [1 ]
Krug, Norbert [1 ]
机构
[1] Fraunhofer Inst Toxicol & Expt Med, D-30625 Hannover, Germany
[2] Hannover Med Sch, Dept Biometr, D-3000 Hannover, Germany
[3] GlaxoSmithKline, Stevenage, Herts, England
关键词
ALLERGIC RHINITIS; EXPOSURE UNIT; NASAL SPRAY; PLACEBO; ONSET; CETIRIZINE; PSEUDOEPHEDRINE; FEXOFENADINE; DURATION; EFFICACY;
D O I
10.1016/j.anai.2010.12.018
中图分类号
R392 [医学免疫学];
学科分类号
100102 ;
摘要
Background: An environmental challenge chamber (ECC) is a useful tool to expose allergic patients to relevant allergens in a controlled indoor setting and to test anti-allergic treatment. Hitherto, ECC studies with grass pollen are conducted primarily outside of the pollen season to avoid the influence of natural pollen exposure. Objective: To investigate whether an established anti-allergic treatment, a combination of cetirizine (CET) and pseudoephedrine (PSE), shows an equivalent treatment effect within and outside of the grass pollen season when tested in an ECC. Methods: In a randomized, placebo-controlled, double-blind, four-way crossover study, the effect of a combination of 10 mg CET and 120 mg PSE compared with placebo on nasal symptoms, nasal flow, and nasal secretion was investigated in 70 patients with seasonal allergic rhinitis. Subjects underwent four 6-hour pollen challenges in an ECC with administration of the drugs after 2 hours. Two challenges were conducted within the grass pollen season and two out of the grass pollen season. Results: The active treatment significantly improved nasal symptoms and nasal flow and significantly reduced the amount of nasal secretion compared with placebo both within and outside of the pollen season (P < .0001 each). The treatment effect was not different between the seasons (P > .05). Conclusion: Controlled allergen provocation in an ECC can be used to test anti-allergic treatment both within and outside of the grass pollen season. Ann Allergy Asthma Immunol. 2011;106:336-341.
引用
收藏
页码:336 / 341
页数:6
相关论文
共 15 条
[1]  
Akerlund Anders, 2005, J Allergy Clin Immunol, V115, pS460, DOI 10.1016/j.jaci.2004.12.016
[2]  
Badorrek P, 2009, INT J CLIN PHARM TH, V47, P71
[3]   Onset of action, efficacy, and safety of fexofenadine 60 mg/pseudoephedrine 120 mg versus placebo in the Atlanta allergen exposure unit [J].
Berkowitz, RB ;
Woodworth, GG ;
Lutz, C ;
Weiler, K ;
Weiler, J ;
Moss, M ;
Meeves, S .
ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY, 2002, 89 (01) :38-45
[4]   Cetirizine, Ioratadine, or placebo in subjects with seasonal allergic rhinitis: Effects after controlled ragweed pollen challenge in an environmental exposure unit [J].
Day, JH ;
Briscoe, M ;
Widlitz, MD .
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, 1998, 101 (05) :638-645
[5]  
Grosclaude M., 1997, Rhinology (Utrecht), V35, P67
[6]   Bepotastine besilate OD tablets suppress nasal symptoms caused by Japanese cedar pollen exposure in an artificial exposure chamber (OHIO Chamber) [J].
Hashiguchi, Kazuhiro ;
Tang, Huaipeng ;
Fujita, Toshio ;
Suematsu, Kiyochika ;
Gotoh, Minoru ;
Okubo, Kimihiro .
EXPERT OPINION ON PHARMACOTHERAPY, 2009, 10 (04) :523-529
[7]   Levocetirizine has a longer duration of action on improving total nasal symptoms score than fexofenadine after single administration [J].
Horak, F ;
Zieglmayer, PU ;
Zieglmayer, R ;
Kavina, A ;
Lemell, P .
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 2005, 60 (01) :24-31
[8]   Efficacy and safety relative to placebo of an oral formulation of cetirizine and sustained-release pseudoephedrine in the management of nasal congestion [J].
Horak, F ;
Toth, J ;
Marks, B ;
Stubner, UP ;
Berger, UE ;
Jager, S ;
Burtin, B ;
Duby, C .
ALLERGY, 1998, 53 (09) :849-856
[9]   Effect of loteprednol etabonate nasal spray suspension on seasonal allergic rhinitis assessed by allergen challenge in an environmental exposure unit [J].
Krug, N ;
Hohlfeld, JM ;
Geldmacher, H ;
Larbig, M ;
Heermann, R ;
LaVallee, N ;
Nguyen, DT ;
Petzold, U ;
Hermann, R .
ALLERGY, 2005, 60 (03) :354-359
[10]   Validation of an environmental exposure unit for controlled human inhalation studies with grass pollen in patients with seasonal allergic rhinitis [J].
Krug, N ;
Loedding, H ;
Hohlfeld, JM ;
Larbig, M ;
Buckendahl, A ;
Badorrek, P ;
Geldmacher, H ;
Behnke, W ;
Dunkhorst, W ;
Windt, H ;
Luettig, B ;
Koch, W .
CLINICAL AND EXPERIMENTAL ALLERGY, 2003, 33 (12) :1667-1674