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Validation of an environmental exposure unit for controlled human inhalation studies with grass pollen in patients with seasonal allergic rhinitis
Summary Background There is an increasing need for allergen inhalation systems to perform basic clinical research and test anti‐allergic drugs under well‐controlled conditions. This requires stability of environmental conditions like temperature and humidity, as well as allergen concentration and re...
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| Published in: | Clinical and experimental allergy 2003-12, Vol.33 (12), p.1667-1674 |
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| Main Authors: | , , , , , , , , , , , |
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| cites | cdi_FETCH-LOGICAL-c4930-7c8c1cedcbf71959d38e1ef63555371a939c6ba46a6a01fd741441dbf32b96923 |
| container_end_page | 1674 |
| container_issue | 12 |
| container_start_page | 1667 |
| container_title | Clinical and experimental allergy |
| container_volume | 33 |
| creator | Krug, N. Loedding, H. Hohlfeld, J. M. Larbig, M. Buckendahl, A. Badorrek, P. Geldmacher, H. Behnke, W. Dunkhorst, W. Windt, H. Luettig, B. Koch, W. |
| description | Summary
Background
There is an increasing need for allergen inhalation systems to perform basic clinical research and test anti‐allergic drugs under well‐controlled conditions. This requires stability of environmental conditions like temperature and humidity, as well as allergen concentration and reproducible induction of allergic symptoms.
Objective
The aim of this study was to validate an environmental exposure unit for controlled human pollen inhalation studies in participants with seasonal allergic rhinitis.
Methods
Temperature, relative humidity, and air flow rate were kept constant with an air conditioning system. Pollen atmosphere was generated using a specially designed feeding system and monitored online by laser counter and offline using rotating rod samplers. Efficacy (total nasal symptom score, nasal air flow rate, nasal secretion) and safety (lung function) parameters were evaluated at different pollen concentrations and repeated allergen challenges.
Results
Temperature, humidity, and air flow rate in the environmental exposure unit remained constant within a range of |
| doi_str_mv | 10.1111/j.1365-2222.2003.01810.x |
| format | article |
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Background
There is an increasing need for allergen inhalation systems to perform basic clinical research and test anti‐allergic drugs under well‐controlled conditions. This requires stability of environmental conditions like temperature and humidity, as well as allergen concentration and reproducible induction of allergic symptoms.
Objective
The aim of this study was to validate an environmental exposure unit for controlled human pollen inhalation studies in participants with seasonal allergic rhinitis.
Methods
Temperature, relative humidity, and air flow rate were kept constant with an air conditioning system. Pollen atmosphere was generated using a specially designed feeding system and monitored online by laser counter and offline using rotating rod samplers. Efficacy (total nasal symptom score, nasal air flow rate, nasal secretion) and safety (lung function) parameters were evaluated at different pollen concentrations and repeated allergen challenges.
Results
Temperature, humidity, and air flow rate in the environmental exposure unit remained constant within a range of <2%. The spatial distribution and the temporal stability of the pollen concentration varied only slightly over 4 h (±10% and <4%, respectively). Dose‐dependent induction of allergic rhinitis symptoms, reduction in nasal air flow rate, and increase in nasal secretion were observed over time. These effects were reproducible from day to day. Lung function remained clinically normal at all concentrations and from day to day.
Conclusions
Thus, pollen exposure in the environmental exposure unit is an effective, reproducible, safe, and suitable method for single‐centre clinical studies on the efficacy of anti‐allergic treatment or basic clinical research.</description><identifier>ISSN: 0954-7894</identifier><identifier>EISSN: 1365-2222</identifier><identifier>DOI: 10.1111/j.1365-2222.2003.01810.x</identifier><identifier>PMID: 14656353</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Science Ltd</publisher><subject>Adult ; allergen challenge ; Allergens - analysis ; Allergic diseases ; Biological and medical sciences ; Bronchial Hyperreactivity ; Environmental Exposure ; environmental exposure unit ; Female ; grass pollen ; Humans ; Immunopathology ; Male ; Medical sciences ; Nasal Provocation Tests - instrumentation ; Nasal Provocation Tests - methods ; Poaceae ; Pollen ; Respiratory and ent allergic diseases ; Rhinitis, Allergic, Seasonal - immunology ; seasonal allergic rhinitis ; Time Factors</subject><ispartof>Clinical and experimental allergy, 2003-12, Vol.33 (12), p.1667-1674</ispartof><rights>2004 INIST-CNRS</rights><rights>Copyright Blackwell Scientific Publications Ltd. Dec 2003</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4930-7c8c1cedcbf71959d38e1ef63555371a939c6ba46a6a01fd741441dbf32b96923</citedby><cites>FETCH-LOGICAL-c4930-7c8c1cedcbf71959d38e1ef63555371a939c6ba46a6a01fd741441dbf32b96923</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=15530379$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/14656353$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Krug, N.</creatorcontrib><creatorcontrib>Loedding, H.</creatorcontrib><creatorcontrib>Hohlfeld, J. M.</creatorcontrib><creatorcontrib>Larbig, M.</creatorcontrib><creatorcontrib>Buckendahl, A.</creatorcontrib><creatorcontrib>Badorrek, P.</creatorcontrib><creatorcontrib>Geldmacher, H.</creatorcontrib><creatorcontrib>Behnke, W.</creatorcontrib><creatorcontrib>Dunkhorst, W.</creatorcontrib><creatorcontrib>Windt, H.</creatorcontrib><creatorcontrib>Luettig, B.</creatorcontrib><creatorcontrib>Koch, W.</creatorcontrib><title>Validation of an environmental exposure unit for controlled human inhalation studies with grass pollen in patients with seasonal allergic rhinitis</title><title>Clinical and experimental allergy</title><addtitle>Clin Exp Allergy</addtitle><description>Summary
Background
There is an increasing need for allergen inhalation systems to perform basic clinical research and test anti‐allergic drugs under well‐controlled conditions. This requires stability of environmental conditions like temperature and humidity, as well as allergen concentration and reproducible induction of allergic symptoms.
Objective
The aim of this study was to validate an environmental exposure unit for controlled human pollen inhalation studies in participants with seasonal allergic rhinitis.
Methods
Temperature, relative humidity, and air flow rate were kept constant with an air conditioning system. Pollen atmosphere was generated using a specially designed feeding system and monitored online by laser counter and offline using rotating rod samplers. Efficacy (total nasal symptom score, nasal air flow rate, nasal secretion) and safety (lung function) parameters were evaluated at different pollen concentrations and repeated allergen challenges.
Results
Temperature, humidity, and air flow rate in the environmental exposure unit remained constant within a range of <2%. The spatial distribution and the temporal stability of the pollen concentration varied only slightly over 4 h (±10% and <4%, respectively). Dose‐dependent induction of allergic rhinitis symptoms, reduction in nasal air flow rate, and increase in nasal secretion were observed over time. These effects were reproducible from day to day. Lung function remained clinically normal at all concentrations and from day to day.
Conclusions
Thus, pollen exposure in the environmental exposure unit is an effective, reproducible, safe, and suitable method for single‐centre clinical studies on the efficacy of anti‐allergic treatment or basic clinical research.</description><subject>Adult</subject><subject>allergen challenge</subject><subject>Allergens - analysis</subject><subject>Allergic diseases</subject><subject>Biological and medical sciences</subject><subject>Bronchial Hyperreactivity</subject><subject>Environmental Exposure</subject><subject>environmental exposure unit</subject><subject>Female</subject><subject>grass pollen</subject><subject>Humans</subject><subject>Immunopathology</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Nasal Provocation Tests - instrumentation</subject><subject>Nasal Provocation Tests - methods</subject><subject>Poaceae</subject><subject>Pollen</subject><subject>Respiratory and ent allergic diseases</subject><subject>Rhinitis, Allergic, Seasonal - immunology</subject><subject>seasonal allergic rhinitis</subject><subject>Time Factors</subject><issn>0954-7894</issn><issn>1365-2222</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><recordid>eNqNkctu1TAQhi1ERU8Lr4AsJNjlYMe5ecGiOmrLpQJUcRMby3GcHh8cO9hJe_oaPDGTJmolVszGlub7_5nRjxCmZE2hXu_WlBV5kkKtU0LYmtAKevtHaHXfeIxWhOdZUlY8O0RHMe4IkDmvnqBDmhV5wXK2Qn--SWsaORjvsG-xdFi7axO867QbpMV63_s4Bo1HZwbc-oCVd0Pw1uoGb8cOBMZtpZ0d4jA2Rkd8Y4YtvgoyRtxP6AThHhgwXbpRy-gdTJDQD1dG4bA1MMPEp-iglTbqZ8t7jL6enX7ZvE0uPp2_25xcJCrjjCSlqhRVulF1W1Ke84ZVmuoWzspzVlLJGVdFLbNCFpLQtikzmmW0qVuW1rzgKTtGr2bfPvjfo46D6ExU2lrptB-joDylFecMwBf_gDs_Bth9Yjg40ZQCVM2QCj7GoFvRB9PJcCsoEVNoYiembMSUjZhCE3ehiT1Iny_-Y93p5kG4pATAywWQUUnbBumUiQ8cHExYyYF7M3M3xurb_15AbE5Pph_ok1lv4qD393oZfomiZGUuvn88F58v058fzn5civfsL_KlxL0</recordid><startdate>200312</startdate><enddate>200312</enddate><creator>Krug, N.</creator><creator>Loedding, H.</creator><creator>Hohlfeld, J. M.</creator><creator>Larbig, M.</creator><creator>Buckendahl, A.</creator><creator>Badorrek, P.</creator><creator>Geldmacher, H.</creator><creator>Behnke, W.</creator><creator>Dunkhorst, W.</creator><creator>Windt, H.</creator><creator>Luettig, B.</creator><creator>Koch, W.</creator><general>Blackwell Science Ltd</general><general>Blackwell</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>H94</scope><scope>K9.</scope></search><sort><creationdate>200312</creationdate><title>Validation of an environmental exposure unit for controlled human inhalation studies with grass pollen in patients with seasonal allergic rhinitis</title><author>Krug, N. ; Loedding, H. ; Hohlfeld, J. M. ; Larbig, M. ; Buckendahl, A. ; Badorrek, P. ; Geldmacher, H. ; Behnke, W. ; Dunkhorst, W. ; Windt, H. ; Luettig, B. ; Koch, W.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4930-7c8c1cedcbf71959d38e1ef63555371a939c6ba46a6a01fd741441dbf32b96923</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2003</creationdate><topic>Adult</topic><topic>allergen challenge</topic><topic>Allergens - analysis</topic><topic>Allergic diseases</topic><topic>Biological and medical sciences</topic><topic>Bronchial Hyperreactivity</topic><topic>Environmental Exposure</topic><topic>environmental exposure unit</topic><topic>Female</topic><topic>grass pollen</topic><topic>Humans</topic><topic>Immunopathology</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Nasal Provocation Tests - instrumentation</topic><topic>Nasal Provocation Tests - methods</topic><topic>Poaceae</topic><topic>Pollen</topic><topic>Respiratory and ent allergic diseases</topic><topic>Rhinitis, Allergic, Seasonal - immunology</topic><topic>seasonal allergic rhinitis</topic><topic>Time Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Krug, N.</creatorcontrib><creatorcontrib>Loedding, H.</creatorcontrib><creatorcontrib>Hohlfeld, J. M.</creatorcontrib><creatorcontrib>Larbig, M.</creatorcontrib><creatorcontrib>Buckendahl, A.</creatorcontrib><creatorcontrib>Badorrek, P.</creatorcontrib><creatorcontrib>Geldmacher, H.</creatorcontrib><creatorcontrib>Behnke, W.</creatorcontrib><creatorcontrib>Dunkhorst, W.</creatorcontrib><creatorcontrib>Windt, H.</creatorcontrib><creatorcontrib>Luettig, B.</creatorcontrib><creatorcontrib>Koch, W.</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><jtitle>Clinical and experimental allergy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Krug, N.</au><au>Loedding, H.</au><au>Hohlfeld, J. M.</au><au>Larbig, M.</au><au>Buckendahl, A.</au><au>Badorrek, P.</au><au>Geldmacher, H.</au><au>Behnke, W.</au><au>Dunkhorst, W.</au><au>Windt, H.</au><au>Luettig, B.</au><au>Koch, W.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Validation of an environmental exposure unit for controlled human inhalation studies with grass pollen in patients with seasonal allergic rhinitis</atitle><jtitle>Clinical and experimental allergy</jtitle><addtitle>Clin Exp Allergy</addtitle><date>2003-12</date><risdate>2003</risdate><volume>33</volume><issue>12</issue><spage>1667</spage><epage>1674</epage><pages>1667-1674</pages><issn>0954-7894</issn><eissn>1365-2222</eissn><abstract>Summary
Background
There is an increasing need for allergen inhalation systems to perform basic clinical research and test anti‐allergic drugs under well‐controlled conditions. This requires stability of environmental conditions like temperature and humidity, as well as allergen concentration and reproducible induction of allergic symptoms.
Objective
The aim of this study was to validate an environmental exposure unit for controlled human pollen inhalation studies in participants with seasonal allergic rhinitis.
Methods
Temperature, relative humidity, and air flow rate were kept constant with an air conditioning system. Pollen atmosphere was generated using a specially designed feeding system and monitored online by laser counter and offline using rotating rod samplers. Efficacy (total nasal symptom score, nasal air flow rate, nasal secretion) and safety (lung function) parameters were evaluated at different pollen concentrations and repeated allergen challenges.
Results
Temperature, humidity, and air flow rate in the environmental exposure unit remained constant within a range of <2%. The spatial distribution and the temporal stability of the pollen concentration varied only slightly over 4 h (±10% and <4%, respectively). Dose‐dependent induction of allergic rhinitis symptoms, reduction in nasal air flow rate, and increase in nasal secretion were observed over time. These effects were reproducible from day to day. Lung function remained clinically normal at all concentrations and from day to day.
Conclusions
Thus, pollen exposure in the environmental exposure unit is an effective, reproducible, safe, and suitable method for single‐centre clinical studies on the efficacy of anti‐allergic treatment or basic clinical research.</abstract><cop>Oxford, UK</cop><pub>Blackwell Science Ltd</pub><pmid>14656353</pmid><doi>10.1111/j.1365-2222.2003.01810.x</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0954-7894 |
| ispartof | Clinical and experimental allergy, 2003-12, Vol.33 (12), p.1667-1674 |
| issn | 0954-7894 1365-2222 |
| language | eng |
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| source | Wiley |
| subjects | Adult allergen challenge Allergens - analysis Allergic diseases Biological and medical sciences Bronchial Hyperreactivity Environmental Exposure environmental exposure unit Female grass pollen Humans Immunopathology Male Medical sciences Nasal Provocation Tests - instrumentation Nasal Provocation Tests - methods Poaceae Pollen Respiratory and ent allergic diseases Rhinitis, Allergic, Seasonal - immunology seasonal allergic rhinitis Time Factors |
| title | Validation of an environmental exposure unit for controlled human inhalation studies with grass pollen in patients with seasonal allergic rhinitis |
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