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  • 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

  • 1,
  • 2,
  • 3,
  • 1,
  • 4,
  • 5 and
  • 6
Clinical and Translational Allergy20133 (Suppl 2) :P43

https://doi.org/10.1186/2045-7022-3-S2-P43

  • Published:

Keywords

  • Visual Analogical Scale
  • Active Group
  • Rhinitis
  • Allergic Rhinitis
  • Interim Analysis

Background

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.

Methods

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.

Results

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).

Conclusion

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.

Authors’ Affiliations

(1)
Hospital Clinic Universitari de Barcelona, Allergy Service, Barcelona, Spain
(2)
Complejo Hospitalario de Santiago. Hospital del Conxo, Allergy Service, Santiago de Compostela, Spain
(3)
Hospital Universitario y Politecnico La Fe, Allergy Service, Valencia, Spain
(4)
Hospital General de Castellon, Allergy Service, Castellon, Spain
(5)
Hospital Clinico Universitario de Valencia, Allergy Service, Valencia, Spain
(6)
Stallergenes Iberica, Medical Department, Barcelona, Spain

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