RhinoconjunctivitisPhase 3ACRINCT00540631
Multicenter Trial of Immunotherapy With House Dust Mite Allergoid
A Phase 3 study testing specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU) in people with Rhinoconjunctivitis, run by Allergopharma GmbH & Co. KG at 1 site in Germany.
Trial summary
Multicenter Immunotherapy House Dust Mite Allergoid Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rhinoconjunctivitis
- What is being tested?
- specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2007to Dec 2011
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Positive SPT
- Positive EAST
- Positive specific provocation test
Who cannot join
- Serious chronic diseases
- other perennial allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre Randomized Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of a Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Allergoid Preparation of House Dust Mite (Dermatophagoides Pteronyssinus) in Patients With Rhinitis/Rhinoconjunctivitis and/or Allergic Asthma Bronchiale
Multicenter Immunotherapy House Dust Mite Allergoid
Read the detailed description
A multicentre randomized placebo-controlled double-blind clinical trial for evaluation of safety and efficacy of a specific immunotherapy with an aluminium hydroxide-adsorbed allergoid preparation of house dust mite (Dermatophagoides pteronyssinus) in patients with rhinitis/rhinoconjunctivitis and/or allergic asthma bronchiale
- Conditions
- Rhinoconjunctivitis
- Being tested
- specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU)
- Keywords
- House Dust Mite Allergen, Aluminium hydroxide-adsorbed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU)Biological
Injection Number Date Proposed Dose Individual Dose Strength A=1000 TU/ml B=10000TU/ml ml Dose per Injection
- to be det. A 0.1 100 TU
- 7 (+7) days later A 0.2 200 TU
- 7 (+7) days later A 0.4 400 TU
- 7 (+7) days later A 0.6 600 TU
- 7 (+7) days later B 0.1 1000 TU
- 7 (+7) days later B 0.2 2000 TU
- 7 (+7) days later B 0.4 4000 TU
- 7 (+7) days later B 0.6 6000 TU
Maintenance (Init 2,4) 4-6 weekly B 0.6 6000 TU To be continued Injection Number Date Proposed Dose Individual Dose Strength A=1000 TU/ml B=10000TU/ml ml Dose per Injection
- to be det. A 0.1 100 TU
- 7 (+7) days later A 0.2 200 TU
- 7 (+7) days later A 0.4 400 TU
- 7 (+7) days later A 0.6 600 TU
- 7 (+7) days later B 0.1 1000 TU
- 7 (+7) days later B 0.2 2000 TU
- 7 (+7) days later B 0.4 4000 TU
- 7 (+7) days later B 0.6 6000 TU
Maintenance (Init 2,4) 4-6 weekly B 0.6 6000 TU To be continued
| Study group | Role | What they receive |
|---|---|---|
| P | No intervention | subcutaneous treatment with placebo Placebo- physiological saline containing histamine-dihydrochloride 0.1mL, 0.2mL, 0.4mL, 0.6mL of strength A(1000TU/mL) followed by 0.1mL, 0.4mL, 0.6mL by strength B (10000TU/mL) in weekly intervals |
| A | Experimental | Active treatment with house dust mite extract Receives: Biological: specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the change of the area under the curve (AUC)of the Symptom-Medication-Score (SMS)after 2 years of double-blind treatment to baseline
Measured: November 2007 - February 2010
Secondary outcomes (4)
Change of the AUC of the SMS after one year to baseline.
Measured: 1 year
Change of Nasal Eosinophil Cationic Protein (ECP) after 2 years to baseline
Measured: 2 years
Immunologic changes IgE, IgG1 and IgG4
Measured: 2 years
Tolerability and safety of treatments during the entire study period
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionAug 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergopharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herbert Riechelmann, MD, Principal investigator, University Ulm, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540631
- Sponsor's protocol ID
- AL0106ac
- Other IDs
- 2006-000934-11
- Acronym
- ACRI
- Status last verified
- Feb 2013
- First submitted
- 5 Oct 2007
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomized Placebo-controlled Double-blind Clinical Trial for Evaluation of Safety and Efficacy of a Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Allergoid Preparation of House Dust Mite (Dermatophagoides Pteronyssinus) in Patients With Rhinitis/Rhinoconjunctivitis and/or Allergic Asthma Bronchiale
- ClinicalTrials.gov ID
- NCT00540631
- Acronym / sponsor ID
- ACRI / AL0106ac
- Conditions
- Rhinoconjunctivitis
- Keywords
- House Dust Mite Allergen, Aluminium hydroxide-adsorbed
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Allergopharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 8 Oct 2007 (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.
Multicenter Immunotherapy House Dust Mite Allergoid
Detailed description
A multicentre randomized placebo-controlled double-blind clinical trial for evaluation of safety and efficacy of a specific immunotherapy with an aluminium hydroxide-adsorbed allergoid preparation of house dust mite (Dermatophagoides pteronyssinus) in patients with rhinitis/rhinoconjunctivitis and/or allergic asthma bronchiale
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P | No intervention | –subcutaneous treatment with placebo Placebo- physiological saline containing histamine-dihydrochloride 0.1mL, 0.2mL, 0.4mL, 0.6mL of strength A(1000TU/mL) followed by 0.1mL, 0.4mL, 0.6mL by strength B (10000TU/mL) in weekly intervals |
| A | Experimental | Biological: specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU)Active treatment with house dust mite extract |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Positive SPT
- Positive EAST
- Positive specific provocation test
Key exclusion criteria (2 listed)
- Serious chronic diseases
- other perennial allergies
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 |
|---|---|---|
| specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU)Injection Number Date Proposed Dose Individual Dose Strength A=1000 TU/ml B=10000TU/ml ml Dose per Injection 1. to be det. A 0.1 100 TU 2. 7 (+7) days later A 0.2 200 TU 3. 7 (+7) days later A 0.4 400 TU 4. 7 (+7) days later A 0.6 600 TU 5. 7 (+7) days later B 0.1 1000 TU 6. 7 (+7) days later B 0.2 2000 TU 7. 7 (+7) days later B 0.4 4000 TU 8. 7 (+7) days later B 0.6 6000 TU Maintenance (Init 2,4) 4-6 weekly B 0.6 6000 TU To be continued Injection Number Date Proposed Dose Individual Dose Strength A=1000 TU/ml B=10000TU/ml ml Dose per Injection 1. to be det. A 0.1 100 TU 2. 7 (+7) days later A 0.2 200 TU 3. 7 (+7) days later A 0.4 400 TU 4. 7 (+7) days later A 0.6 600 TU 5. 7 (+7) days later B 0.1 1000 TU 6. 7 (+7) days later B 0.2 2000 TU 7. 7 (+7) days later B 0.4 4000 TU 8. 7 (+7) days later B 0.6 6000 TU Maintenance (Init 2,4) 4-6 weekly B 0.6 6000 TU To be continued | Biological | A |
Primary outcome
The primary endpoint is the change of the area under the curve (AUC)of the Symptom-Medication-Score (SMS)after 2 years of double-blind treatment to baseline
Time frame: November 2007 - February 2010
4 secondary outcomes
Change of the AUC of the SMS after one year to baseline.
Time frame: 1 year
Change of Nasal Eosinophil Cationic Protein (ECP) after 2 years to baseline
Time frame: 2 years
Immunologic changes IgE, IgG1 and IgG4
Time frame: 2 years
Tolerability and safety of treatments during the entire study period
Time frame: 4 years
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 11 Feb 2013.
- leader in specific allergy research and therapyLink provided by the sponsor.
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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.
Herbert Riechelmann, MD principal investigator
University Ulm, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU) in people with Rhinoconjunctivitis, run by Allergopharma GmbH & Co. KG at 1 site in Germany.
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 3 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 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary endpoint is the change of the area under the curve (AUC)of the Symptom-Medication-Score (SMS)after 2 years of double-blind treatment to baseline (time frame: November 2007 - February 2010). 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 Feb 2013.