Status:
COMPLETED
ToleroMune House Dust Mites (HDM) Exposure Chamber Study
Lead Sponsor:
Circassia Limited
Collaborating Sponsors:
Adiga Life Sciences, Inc.
Cetero Research, San Antonio
Conditions:
Rhinoconjunctivitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDM allergens in sensitised patients is associated with poore...
Detailed Description
This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of ToleroMune HDM in HDM allergic subjects with allergic rhinocon...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Male or female, aged 18-65 years.
- Minimum 1-year documented history of rhinoconjunctivitis on exposure to HDM.
- Positive skin prick test to Der p allergen.
- Minimum qualifying rhinoconjunctivitis symptom scores
- Exclusion criteria
- History of asthma (asthma in childhood .
- A history of anaphylaxis to HDM allergen.
- Subjects with an FEV1 \<80% of predicted.
- Subjects who cannot tolerate baseline challenge in the EEC.
- Subjects for whom administration of epinephrine is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
- A history of severe drug allergy, severe angioedema or anaphylactic reaction to food.
- A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment).
Exclusion
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT01447784
Start Date
September 1 2011
End Date
May 1 2013
Last Update
July 17 2013
Active Locations (1)
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1
Cetero Research
Mississauga, Ontario, Canada, L4W 1N2