A randomized, controlled study of specific immunotherapy in monosensitized subjects with seasonal rhinitis: Effect on bronchial hyperresponsiveness, sputum inflammatory markers and development of asthma symptoms

Istituto di Malattie dell'Apparato Respiratorio, Università degli Studi di Catania.
Annali italiani di medicina interna: organo ufficiale della Societa italiana di medicina interna 01/2004; 19(2):98-108.
Source: PubMed


Allergic rhinitis is often associated with bronchial hyperresponsiveness (BHR) and airway inflammation, and it seems to be an important risk factor for the development of asthma. Specific immunotherapy (SIT) reduces symptoms and medication requirements in subjects with allergic rhinitis, but the mechanisms by which SIT promotes these beneficial effects are less clear. We have investigated the effects of Parietaria-SIT on rhinitis symptoms, BHR to inhaled methacholine, eosinophilic inflammation and cytokine production (interferon gamma and interleukin-4) in the sputum. The effect on asthma progression was also examined. Thirty non-asthmatic subjects with seasonal rhinitis and monosensitized to Parietaria judaica participated in a randomized, double-blind, placebo-controlled, parallel group study. Participants were randomly assigned to receive injections of a Parietaria pollen vaccine (n = 15) or matched placebo injections (n = 15) in a rapid updosing cluster regimen for 7 weeks, followed by monthly injections for 34 months. Throughout the 3-year study we collected data on symptoms and medication score, airway responsiveness to methacholine, eosinophilia and soluble cytokines in sputum, followed by a complete evaluation of the clinical course of atopy. Hay fever symptom and medication scores were well controlled by SIT. By the end of the study, in the placebo group, symptom and medication scores significantly increased by a median (interquartile range) of 121% (15-280%) and 263% (0-4400%) respectively (p < 0.01), whereas no significant difference was observed in the SIT group. We found no significant changes in the sputum parameters and methacholine PC15 values in both groups throughout the study. By the end of the investigation, a total of 9 out of 29 participants developed asthma symptoms; of these, seven (47%) belonged to the placebo group, whereas only 2 (14%) to the SIT-treated group (p = 0.056). In conclusion, Parietaria-SIT is effective in controlling hay fever symptoms and rescue medications, but no changes in the BHR to methacholine or sputum eosinophilia were observed. Moreover, Parietaria-SIT appears to prevent the natural progression of allergic rhinitis to asthma, suggesting that SIT should be considered earlier in the management of this condition.


Available from: Nunzio Crimi
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    • "Data on medication scores were available in four trials [29], [30], [33], [36](n = 180). The combined WMD and P value was −1.27 (95% CI, −2.83 to 0.29, P = 0.11; 95% Prediction Interval, −7.19 to 4.65). "
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    ABSTRACT: Although allergen specific immunotherapy (SIT) represents the only immune- modifying and curative option available for patients with allergic rhinitis (AR), the optimal schedule for specific subcutaneous immunotherapy (SCIT) is still unknown. The objective of this study is to systematically assess the efficacy and safety of cluster SCIT for patients with AR. By searching PubMed, EMBASE and the Cochrane clinical trials database from 1980 through May 10th, 2013, we collected and analyzed the randomized controlled trials (RCTs) of cluster SCIT to assess its efficacy and safety. Eight trials involving 567 participants were included in this systematic review. Our meta-analysis showed that cluster SCIT have similar effect in reduction of both rhinitis symptoms and the requirement for anti-allergic medication compared with conventional SCIT, but when comparing cluster SCIT with placebo, no statistic significance were found in reduction of symptom scores or medication scores. Some caution is required in this interpretation as there was significant heterogeneity between studies. Data relating to Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in 3 included studies were analyzed, which consistently point to the efficacy of cluster SCIT in improving quality of life compared to placebo. To assess the safety of cluster SCIT, meta-analysis showed that no differences existed in the incidence of either local adverse reaction or systemic adverse reaction between the cluster group and control group. Based on the current limited evidence, we still could not conclude affirmatively that cluster SCIT was a safe and efficacious option for the treatment of AR patients. Further large-scale, well-designed RCTs on this topic are still needed.
    PLoS ONE 01/2014; 9(1):e86529. DOI:10.1371/journal.pone.0086529 · 3.23 Impact Factor
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    • "Similarly, there is recent evidence that immunotherapy may clinically benefit lower airway function in patients with AR, although the results are not consistent and the study designs vary. Specific immunotherapy is reported to reduce bronchial hyperresponsiveness in patients with AR in some studies [50,51] but not in others [52,53]. In recent reports, treatment with allergen immunotherapy reduced the development of asthma in children and adults with AR [54,55]. "
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    BMC Pulmonary Medicine 02/2006; 6 Suppl 1(Suppl 1):S4. DOI:10.1186/1471-2466-6-S1-S4 · 2.40 Impact Factor
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    ABSTRACT: Tesis Univ. Granada. Departamento de Pediatría. Leída el 5 de octubre de 2009
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