House Dust Mite AllergyNCT01923792
ToleroMune House Dust Mite Follow on Study
An observational study of House Dust Mite Allergy and Rhinoconjunctivitis, run by Circassia Limited.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- House Dust Mite Allergy, Rhinoconjunctivitis
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects previously randomised in study TH002 and completed all dosing visits and the PTC
Who may be able to join
- previously randomised in study TH002, completed all dosing visits and the PTC
Who cannot join
- "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
About this 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
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.
Read the 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.
- Conditions
- House Dust Mite Allergy, Rhinoconjunctivitis
- Keywords
- House Dust Mite Allergy, Rhinoconjunctivitis, Environmental Exposure Unit, Immunotherapy, ToleroMune HDM
- Medical subject headings
- Dust Mite Allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Rhinoconjunctivitis Symptom Scores
Measured: 2 years post after the completion of the baseline environmental exposure chamber (EEC) visit in TH002
Secondary outcomes (5)
Total Nasal Symptom Scores (TNSS)
Measured: Two years after the completion of the baseline EEC visit in TH002
Der p Specific IgA
Measured: Two years after the completion of the baseline EEC visit in TH002
Total Non Nasal Symptom Scores (TNNSS)
Measured: Two years after the completion of the baseline EEC visit in TH002
Der P Specific IgE
Measured: Two years after the completion of the baseline EEC visit in TH002
Der p specific IgG4
Measured: Two years after the completion of the baseline EEC visit in TH002
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for House Dust Mite AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Circassia Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc., Inflamax Research Incorporated
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923792
- Sponsor's protocol ID
- TH002a
- Status last verified
- May 2014
- First submitted
- 16 Jul 2013
- Last updated
- 15 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01923792
- Acronym / sponsor ID
- TH002a
- Conditions
- House Dust Mite Allergy, Rhinoconjunctivitis
- Keywords
- House Dust Mite Allergy, Rhinoconjunctivitis, Environmental Exposure Unit, Immunotherapy, ToleroMune HDM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Circassia LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Adiga Life Sciences, Inc., Inflamax Research Incorporated
- Study start
- Sep 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 16 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects previously randomised in study TH002 and completed all dosing visits and the PTC
Key inclusion criteria (1 listed)
- previously randomised in study TH002, completed all dosing visits and the PTC
Key exclusion criteria (5 listed)
- "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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total Rhinoconjunctivitis Symptom Scores
Time frame: 2 years post after the completion of the baseline environmental exposure chamber (EEC) visit in TH002
5 secondary outcomes
Total Nasal Symptom Scores (TNSS)
Time frame: Two years after the completion of the baseline EEC visit in TH002
Der p Specific IgA
Time frame: Two years after the completion of the baseline EEC visit in TH002
Total Non Nasal Symptom Scores (TNNSS)
Time frame: Two years after the completion of the baseline EEC visit in TH002
Der P Specific IgE
Time frame: Two years after the completion of the baseline EEC visit in TH002
Der p specific IgG4
Time frame: Two years after the completion of the baseline EEC visit in TH002
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of House Dust Mite Allergy and Rhinoconjunctivitis, run by Circassia Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Rhinoconjunctivitis Symptom Scores (time frame: 2 years post after the completion of the baseline environmental exposure chamber (EEC) visit in TH002). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2014.