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Liposome-entrapped D. pteronyssinus vaccination in mild asthma patients : effect of 1-year double-blind , placebo-controlled trial on inflammation , bronchial hyperresponsiveness and immediate and late bronchial responses to the allergen . BACKGROUND Allergen vaccination is effective in mite-allergic asthma . Liposomes are immunological adjuvants that can act as allergen carriers . OBJECTIVE To evaluate the immunological and functional effects of a liposome-entrapped D. pteronyssinus vaccine on mite monosensitive , mild asthma patients . METHODS A double-blind , placebo-controlled trial was conducted on 26 asthma patients who randomly received vaccination or placebo for 1 year . The levels of exposure to Der p 1 allergen were constant during the study . Allergen bronchial challenge was made at the beginning ( T0 ) and after 1 year of treatment ( T12 ) . The day before and 24 h after the allergen provocation , patients were challenged with methacholine ( Mth ) ( until FEV1 fell by 40 % ) and blood and sputum samples were obtained . Dose-response curves to Mth were evaluated in terms of Mth-PD20 ( dose of Mth that induced 20 % drop in FEV1 ) , slope ( Mth-DRS ) and level of plateau . Blood and sputum eosinophils and serum levels of eosinophil cationic protein ( ECP ) and intercellular adhesion molecule-1 ( ICAM-1 ) were measured . RESULTS Groups were comparable at the start of the trial . At TI2 , previous to the allergen challenge , the active group showed higher values of both FEV1 and Mth-PD20 and lower values of Mth-DRS . The number of patients presenting a level of plateau increased in the active group ( from two to four ) and decreased in the placebo group ( from two to one ) . At T12 , before the allergen challenge , serum ECP levels increased in the placebo group and blood eosinophils showed a trend towards lower numbers in the active one . The immediate response and the changes in Mth-DRS values , sputum eosinophils and serum ECP levels following the allergen challenge were attenuated in the active group . CONCLUSION Liposome-entrapped D. Pteronyssinus vaccination : ( i ) protects mild asthma patients from the worsening of asthma due to sustained mite exposure ; and ( ii ) reduces the functional and inflammatory changes induced by allergen bronchial provocation .
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Intervention_Pharmacological
Liposome-entrapped D. pteronyssinus vaccination
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
liposome-entrapped D. pteronyssinus vaccine
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Intervention_Control
placebo
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Intervention_Pharmacological
methacholine
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Outcome_Physical
Blood and sputum eosinophils and serum levels of eosinophil cationic protein ( ECP )
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Outcome_Physical
intercellular adhesion molecule-1 ( ICAM-1 )
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Outcome_Mental
FEV1 and Mth-PD20
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Outcome_Mental
Mth-DRS
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Outcome_Physical
number of patients presenting a level of plateau
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Outcome_Physical
serum ECP levels
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Outcome_Physical
Mth-DRS values , sputum eosinophils and serum ECP levels
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Participant_Condition
mild asthma patients :
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Participant_Condition
mite monosensitive , mild asthma patients .
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Participant_Condition
mild asthma patients