ToleroMune House Dust Mite Follow on Study

NCT01923792 | Completed

• 1 other identifier: TH002a
• Study Type: observational
• Target: 105
• Locations: 0 countries
• Sites: N/A

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.

Conditions

House Dust Mite Allergy; Rhinoconjunctivitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Total Rhinoconjunctivitis Symptom Scores

  2 years post after the completion of the baseline environmental exposure chamber (EEC) visit in TH002

Secondary Outcomes (5)

• 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

Study Arms (3)

Placebo

Subjects previously randomised to receive placebo in study TH002

ToleroMune HMD Group 1

Subjects previously randomised to receive ToleroMune HDM in study TH002

ToleroMune HDM Group 2

Subjects previously randomised to receive ToleroMune HDM in study TH002

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• "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

Sponsors & Collaborators

• Circassia Limited: lead
• Adiga Life Sciences, Inc.: collaborator
• Inflamax Research Incorporated: collaborator

MeSH Terms

Conditions

Dust Mite Allergy

Condition Hierarchy (Ancestors)

Rhinitis, Allergic, Perennial; Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: August 16, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 15, 2014

Record last verified: 2014-05