- Poster presentation
- Open Access
Acoustic rhinometry after nasal provocation test, 6 months interim analysis of alumites study, a randomized, controlled, multicentre phase IV study with house dust mites subcutaneous immunotherapy
Clinical and Translational Allergy volume 3, Article number: P43 (2013)
ALUMITES study was designed to assess the efficacy of house dust mites (HDM: D. pteronyssinus + D. farinae) subcutaneous immunotherapy for the treatment of allergic rhinitis patients along one year. Here we report an interim analysis done after 6 months of treatment.
In this controlled multicentre phase IV study, HDM adult allergic patients were randomized to receive subcutaneous immunotherapy with a 10 IR/ml depot extract plus symptomatic treatment (group A) or only symptomatic treatment (group B) (2:1). Acoustic rhinometry after nasal provocation test (NPT) was selected to objectively assess the efficacy of this treatment by measuring the nasal volume (NV) and minimum cross-sectional area (MCA). A visual analogic scale (VAS) has been used to subjectively assess the efficacy (0-10 scale, lower is better)NPT consists in 5 determinations at intervals of 15 minutes (basal, diluent, 0.01 IR, 0.1 IR, 1 IR) and one last determination 30 minutes after the last administration. The extract used for the NPT was 100 IR/ml of D. pteronyssinus.
Data from 38 of 57 patients were complete to be analyzed. MCA difference from baseline to six months visit was 1.6 cm2 (95% CI: [-2.1, 5.3]) in active group and 0.8 cm2 (95% CI: [-4.3, 5.9]) in control group. NV difference from baseline to six months visit was 37.1 cm3 (95% CI: [-16.9, 91.2]) in active group and -5.8 cm3 (95% CI: [-75.6, 64]) in control group. The analysis of covariance (ANCOVA) showed statistical differences in basal determination of MCA after 6 months treatment (p=0.0001).The symptoms score after the last provocation of 1 IR measured by VAS from baseline to the six month visit had a reduction of -2.4 points (95% CI: [-3.2, -1.6], p<0.0001) in the active group whereas there was no statistical reduction in the control group: -0.7 points (95% CI: [-2.5, 1.0], p=0.577).
Despite of the final low sample to analyze, efficacy is demonstrated with six months of SCIT treatment with 10 IR/ml depot HDM extract that resulted in a significant improve in clinical symptoms, this improvement was not achieved by the control group. Objective assessment of efficacy shows a clear positive trend in minimal cross-sectional area determination.
Rights and permissions
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
About this article
Cite this article
Sanchez, J., Vidal, C., Hernandez, D. et al. Acoustic rhinometry after nasal provocation test, 6 months interim analysis of alumites study, a randomized, controlled, multicentre phase IV study with house dust mites subcutaneous immunotherapy. Clin Transl Allergy 3 (Suppl 2), P43 (2013). https://doi.org/10.1186/2045-7022-3-S2-P43
- Visual Analogical Scale
- Active Group
- Allergic Rhinitis
- Interim Analysis