ToleroMune House Dust Mite Follow on Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01923792

Enrollment

105

Registered

2013-08-16

Start date

2013-09-30

Completion date

2014-04-30

Last updated

2014-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

House Dust Mite Allergy, Rhinoconjunctivitis

Keywords

House Dust Mite Allergy, Rhinoconjunctivitis, Environmental Exposure Unit, Immunotherapy, ToleroMune HDM

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Total Rhinoconjunctivitis Symptom Scores	2 years post after the completion of the baseline environmental exposure chamber (EEC) visit in TH002

Secondary

Measure	Time frame
Total Nasal Symptom Scores (TNSS)	Two years after the completion of the baseline EEC visit in TH002
Der p Specific IgA	Two years after the completion of the baseline EEC visit in TH002
Total Non Nasal Symptom Scores (TNNSS)	Two years after the completion of the baseline EEC visit in TH002
Der P Specific IgE	Two years after the completion of the baseline EEC visit in TH002
Der p specific IgG4	Two years after the completion of the baseline EEC visit in TH002

Outcome results