Perennial Allergic RhinoconjunctivitisPhase 2NCT00574704
A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis
A Phase 2 study testing CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) in people with Perennial Allergic Rhinoconjunctivitis and House Dust Mite Allergy, run by Cytos Biotechnology AG.
Trial summary
The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind, placebo-controlled setting Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Perennial Allergic Rhinoconjunctivitis, House Dust Mite Allergy
- What is being tested?
- CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Mar 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite allergens
Who cannot join
- Clinically relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments
- Use of any concomitant medication that could affect the patient's study treatment response or assessment results
About this study
Official title: Double Blind Placebo Controlled Study to Assess Efficacy and Safety of a Combined Allergen Vaccine (CYT005-AllQbG10) and Its Single Components in Patients With House Dust Mite Allergy
The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind, placebo-controlled setting
- Being tested
- CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10), House dust mite allergen extract in combination with CYT003-QbG10-placebo, CYT003-AllQbG10 in combination with house dust mite allergen extract placebo, CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo
- 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.
CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)Drug
subcutaneous injections at 6 visits
House dust mite allergen extract in combination with CYT003-QbG10-placeboDrug
subcutaneous injections at 6 visits
CYT003-AllQbG10 in combination with house dust mite allergen extract placeboDrug
subcutaneous injections at 6 visits
CYT003-QbG10-placebo in combination with house dust mite allergen extract placeboDrug
subcutaneous injections at 6 visits
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) |
| 2 | Placebo comparator | Not described Receives: Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo |
| 3 | Experimental | Not described Receives: Drug: CYT003-AllQbG10 in combination with house dust mite allergen extract placebo |
| 4 | Placebo comparator | Not described Receives: Drug: CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conjunctival Provocation Test (CPT) With House Dust Mite Allergen Solutions. Change of Median Individual Allergen Tolerance Compared to Baseline (Factor of Increase in Allergen Concentration to Induce a Threshold CPT Score ≥ 2)
The outcome measure is a conjunctival provocation test (CPT) with house dust mite allergen solutions. CPT score was measured as a sum of the following assessed symptoms: conjunctival hyperemia, tearing, itching, burning and swelling of eyelids. Each of the assessed symptom could be absent (0), mild (1 point), moderate (2 points) or severe (3 points). The provocation tests started with the maximal dilution of the allergen 1:1000. If the sum of the reached CPT score was <10 points, the test continued with the next dilution step 1:100. This procedure was repeated until patients reached the CPT score ≥ 10 points or the provocation solution reached the maximal concentration 1:1 (undiluted).
The outcome is then given as the change of median individual allergen tolerance at month two compared to baseline. The change is expressed as a factor of increase in allergen concentration to induce a threshold CPT score ≥ 2.
Measured: baseline versus 2 months after baseline
Secondary outcomes (1)
Safety and Tolerability of the Study Treatment by Collection of Adverse Events
Measured: about 30 min. at each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startSep 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Perennial Allergic RhinoconjunctivitisStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytos Biotechnology AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philipp Mueller, MD, Study director, Cytos Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574704
- Sponsor's protocol ID
- CYT005-AllQbG10 03
- Status last verified
- Feb 2013
- First submitted
- 14 Dec 2007
- Last updated
- 11 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Placebo Controlled Study to Assess Efficacy and Safety of a Combined Allergen Vaccine (CYT005-AllQbG10) and Its Single Components in Patients With House Dust Mite Allergy
- ClinicalTrials.gov ID
- NCT00574704
- Acronym / sponsor ID
- CYT005-AllQbG10 03
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cytos Biotechnology AGIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 17 Dec 2007 (estimated)
- Results
- Posted 11 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to test the efficacy of the combination treatment AllQbG10 in patients with perennial allergic rhinoconjunctivitis due to house dust mite allergy in a double-blind, placebo-controlled setting
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) |
| 2 | Placebo comparator | Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo |
| 3 | Experimental | Drug: CYT003-AllQbG10 in combination with house dust mite allergen extract placebo |
| 4 | Placebo comparator | Drug: CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite allergens
Key exclusion criteria (2 listed)
- Clinically relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments
- Use of any concomitant medication that could affect the patient's study treatment response or assessment results
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)subcutaneous injections at 6 visits | Drug | 1 |
| House dust mite allergen extract in combination with CYT003-QbG10-placebosubcutaneous injections at 6 visits | Drug | 2 |
| CYT003-AllQbG10 in combination with house dust mite allergen extract placebosubcutaneous injections at 6 visits | Drug | 3 |
| CYT003-QbG10-placebo in combination with house dust mite allergen extract placebosubcutaneous injections at 6 visits | Drug | 4 |
Primary outcome
Conjunctival Provocation Test (CPT) With House Dust Mite Allergen Solutions. Change of Median Individual Allergen Tolerance Compared to Baseline (Factor of Increase in Allergen Concentration to Induce a Threshold CPT Score ≥ 2)
Time frame: baseline versus 2 months after baseline
The outcome measure is a conjunctival provocation test (CPT) with house dust mite allergen solutions. CPT score was measured as a sum of the following assessed symptoms: conjunctival hyperemia, tearing, itching, burning and swelling of eyelids. Each of the assessed symptom could be absent (0), mild (1 point), moderate (2 points) or severe (3 points). The provocation tests started with the maximal dilution of the allergen 1:1000. If the sum of the reached CPT score was <10 points, the test continued with the next dilution step 1:100. This procedure was repeated until patients reached the CPT score ≥ 10 points or the provocation solution reached the maximal concentration 1:1 (undiluted). The outcome is then given as the change of median individual allergen tolerance at month two compared to baseline. The change is expressed as a factor of increase in allergen concentration to induce a threshold CPT score ≥ 2.
1 secondary outcome
Safety and Tolerability of the Study Treatment by Collection of Adverse Events
Time frame: about 30 min. at each visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Perennial Allergic Rhinoconjunctivitis
RecruitingPhase 3
Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df
Rhinitis, Rhinoconjunctivitis
Not yet recruitingPhase 2/3
Clinical Trial to Evaluate the Efficacy and Safety of Polymerized, Mannan-Conjugated Dermatophagoides Allergen Extract
Allergic Rhinitis, Allergic Asthma
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.
Philipp Mueller, MD study director
Cytos Biotechnology
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) in people with Perennial Allergic Rhinoconjunctivitis and House Dust Mite Allergy, run by Cytos Biotechnology AG.
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 2 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 11 Jul 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Conjunctival Provocation Test (CPT) With House Dust Mite Allergen Solutions. Change of Median Individual Allergen Tolerance Compared to Baseline (Factor of Increase in Allergen Concentration to Induce a Threshold CPT Score ≥ 2) (time frame: baseline versus 2 months after baseline). 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 11 Jul 2013.