ToleroMune House Dust Mite (HDM) Tolerability Study

Launched by CIRCASSIA LIMITED · Sep 20, 2013

Keywords

ClinConnect Summary

A multi-centre, randomised, double-blind, placebo-controlled, parallel-group, multiple dose study to evaluate the tolerability of four intradermal doses of TM-HDM in subjects with controlled asthma and HDM-induced rhinoconjunctivitis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female, aged 18-65 years.
• • Asthma controlled by Step 1 or Step 2 treatment as defined by GINA in the four weeks prior to randomisation.
• • Asthma controlled by Step 1 or Step 2 treatment as defined by GINA in the four weeks prior to randomisation.
• • No change in asthma controller treatment (dose, frequency) in the four weeks prior to randomisation.
• • A reliable history consistent with rhinoconjunctivitis on exposure to HDM for at least 1 year that has required symptomatic treatment on at least one occasion during the year prior to randomisation
• • Positive skin prick test to Dermatophagoides pteronyssinus with an average wheal diameter at least 5 mm larger than that produced by the negative control.
• • ImmunoCAP® Dermatophagoides pteronyssinus-specific Immunoglobulin E ≥ 0.35 kU/L.
• Exclusion Criteria:
• • History of life-threatening asthma
• • Asthma exacerbation in the 12 weeks prior to randomisation
• • Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) \< 80 % of predicted, regardless of the cause.
• • Post-bronchodilator FEV1/Forced Vital Capacity ratio of \< 0.7.
• • Concurrent respiratory disease that would confound study participation or affect subject safety.
• • Non-HDM allergy that may significantly interfere with the results of this study.
• • 7. Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5 years prior to screening.