Clinical trial NCT01923792: ToleroMune House Dust Mite Follow on Study
Official title: An Optional Follow-Up Study to Evaluate the Continued Efficacy of ToleroMune HDM in House Dust Mite Allergic Subjects Following Challenge With House Dust Mite Allergen in an Environmental Exposure Chamber
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: House Dust Mite Allergy
Rhinoconjunctivitis
Keywords: House Dust Mite Allergy
Rhinoconjunctivitis
Environmental Exposure Unit
Immunotherapy
ToleroMune HDM
Lead sponsor: Circassia Limited
Sponsor class: INDUSTRY
Collaborators: name: Adiga Life Sciences, Inc.
name: Inflamax Research Incorporated
First posted: 2013-08-16
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects previously randomised in study TH002 and completed all dosing visits and the PTC

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 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 HDM is currently being developed for the treatment of HDM allergy.

The Purpose of this optional observational follow-on study is to evaluate the continued efficacy of TM-HDM in HDM allergic subjects based on change in TRSS from TH002 baseline approximately two years after the completion of the baseline EEC visit in TH002 following challenge with HDM allergen in an EEC.

Detailed description: Subjects who completed all dosing visits and the post treatment challenge (PTC) in study TH002 will be invited to attend the Screening visit for TH002a. Subjects will attend for 3 visits to the EEU on successive days. Following the last EEC visit a follow-up visit will be performed 3-10 days later.

Eligibility criteria: Inclusion Criteria:

* previously randomised in study TH002, completed all dosing visits and the PTC

Exclusion Criteria:

* "Partly controlled" and "uncontrolled" asthma
* History of anaphylaxis to House Dust Mite allergen
* FEV1 \<80% of predicted.
* Symptoms of a clinically relevant illness
* Subjects who cannot tolerate allergen challenge in the EEC

Primary outcomes:
measure: Total Rhinoconjunctivitis Symptom Scores
timeFrame: 2 years post after the completion of the baseline environmental exposure chamber (EEC) visit in TH002
Secondary outcomes:
measure: Total Nasal Symptom Scores (TNSS)
timeFrame: Two years after the completion of the baseline EEC visit in TH002
measure: Der p Specific IgA
timeFrame: Two years after the completion of the baseline EEC visit in TH002
measure: Total Non Nasal Symptom Scores (TNNSS)
timeFrame: Two years after the completion of the baseline EEC visit in TH002
measure: Der P Specific IgE
timeFrame: Two years after the completion of the baseline EEC visit in TH002
measure: Der p specific IgG4
timeFrame: Two years after the completion of the baseline EEC visit in TH002
Other outcomes:
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