Clinical trial NCT01949441: ToleroMune House Dust Mite (HDM) Tolerability Study
Official title: A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Parallel-Group Study to Assess the Tolerability of ToleroMune House Dust Mite in Subjects With Controlled Asthma and House Dust Mite-Induced Rhinoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhinoconjunctivitis
Keywords: HDM Allergy
Rhinoconjunctivitis
Immunotherapy
ToleroMune HDM
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Adiga Life Sciences, Inc.
First posted: 2013-09-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: House Dust Mites (HDMs) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients.

ToleroMune House Dust Mite (TM-HDM), a combination of seven Synthetic Peptide Immuno-Regulatory Epitopes, is being developed for the treatment of HDM allergy.

This study to assess the tolerability of ToleroMune House Dust Mite in subjects with controlled asthma and house dust mite-induced rhinoconjunctivitis.

Detailed description: 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.

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.

Primary outcomes:
measure: Adverse Events
timeFrame: Up to 19 Weeks
Secondary outcomes:
measure: FEV1 and FVC
timeFrame: Up to 19 Weeks
measure: Peak Expiratory Flow Rate
timeFrame: Up to 19 Weeks
measure: VAS Breathlessness
timeFrame: Up to 19 weeks
measure: Asthma Exacerbations
timeFrame: Up to 19 weeks
measure: Systemic Allergic Reactions
timeFrame: Up to 19 Weeks
measure: Injection Site Examinations
timeFrame: Up to 19 Weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Topstone Research
state: Ontario
Study officials:
References: