ImmunotherapyPhase 3NCT00540150
Compatibility and Immunogenicity of a Short Specific Immunotherapy (SIT) in Contrast to Classic Specific Immunotherapy
A Phase 3 study testing specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot) in people with Immunotherapy, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
We wanted to examine the immunogenicity and safety of a shortened specific immunotherapy in contrast to the standard specific immunotherapy. Therefore, we challenged 12 patients for 14 weeks with the standard specific scheme and 22 patients for 6 weeks with the shortened scheme. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Immunotherapy
- What is being tested?
- specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- May 2004to Mar 2005
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- informed consent of patient and/or parents
- age >6 and <18 years
- bronchial asthma I° or II°
- allergy on house dust-mite
Who cannot join
- age <6 and >18 years
- vital capacity <80% or FEV1 <70%
- pregnancy
- inhalative or systemic steroid use
- bronchial asthma III° or IV°
- heavy exacerbation during the last 3 months
Trial locations and contacts
1 site in 1 country.
Germany1 site
Goethe University, Department of Pulmonology
Frankfurt am Main, Hesse, 60590
About this study
Official title: Compatibility and Immunogenicity of a Short Specific Immunotherapy (SIT) in Contrast to Classic Specific Immunotherapy in a Randomized Study Depending on Mite-Depot Supplement in Children and Adolescents With Allergic Bronchial Asthma.
We wanted to examine the immunogenicity and safety of a shortened specific immunotherapy in contrast to the standard specific immunotherapy.
Therefore, we challenged 12 patients for 14 weeks with the standard specific scheme and 22 patients for 6 weeks with the shortened scheme.
Read the detailed description
see above
- Conditions
- Immunotherapy
- Being tested
- specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)
- Keywords
- Immunotherapy, Mite, Asthma, bronchial provocation, SIT, specific immunotherapy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)Biological
Also called Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany
We treat each patient with mite-allergen following the two different protocols.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Standard specific immunotherapy: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany Receives: Biological: specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot) |
| 2 | Active comparator | Shortened specific immunotherapy: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany Receives: Biological: specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the shortened specific immunotherapy.
Measured: may 2004 - march 2005
Secondary outcomes (1)
Exhaled nitric oxid (eNO) and immunogenicity (IgE, specific IgE, specific IgG) in both groups.
Measured: may 2004 - march 2005
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study startMay 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ImmunotherapyStudies 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
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Allergopharma GmbH & Co. KG
- Investigators
- Stefan Zielen, M.D., Ph.D., Principal investigator, Goethe University, Department of Pulmonology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540150
- Sponsor's protocol ID
- 97/04/FFM
- Status last verified
- Sep 2007
- First submitted
- 2 Oct 2007
- Last updated
- 5 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hansen I, Hormann K, Stuck BA, Schneider-Gene S, Mosges R, Klimek L. [Cluster-immunotherapy in seasonal allergic rhinitis: safety aspects of induction therapy with depot allergoids (Purethal)]. Laryngorhinootologie. 2003 Aug;82(8):558-63. doi: 10.1055/s-2003-41234. German.
PubMed 12915987Tabar AI, Echechipia S, Garcia BE, Olaguibel JM, Lizaso MT, Gomez B, Aldunate MT, Martin S, Marcotegui F. Double-blind comparative study of cluster and conventional immunotherapy schedules with Dermatophagoides pteronyssinus. J Allergy Clin Immunol. 2005 Jul;116(1):109-18. doi: 10.1016/j.jaci.2005.05.005.
PubMed 15990782
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compatibility and Immunogenicity of a Short Specific Immunotherapy (SIT) in Contrast to Classic Specific Immunotherapy in a Randomized Study Depending on Mite-Depot Supplement in Children and Adolescents With Allergic Bronchial Asthma.
- ClinicalTrials.gov ID
- NCT00540150
- Acronym / sponsor ID
- 97/04/FFM
- Conditions
- Immunotherapy
- Keywords
- Immunotherapy, Mite, Asthma, bronchial provocation, SIT, specific immunotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Collaborators
- Allergopharma GmbH & Co. KG
- Study start
- May 2004
- Study completion
- Mar 2005 (actual)
- First posted
- 5 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.
We wanted to examine the immunogenicity and safety of a shortened specific immunotherapy in contrast to the standard specific immunotherapy.
Therefore, we challenged 12 patients for 14 weeks with the standard specific scheme and 22 patients for 6 weeks with the shortened scheme.
Detailed description
see above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)Standard specific immunotherapy: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany |
| 2 | Active comparator | Biological: specific subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)Shortened specific immunotherapy: Novo-Helisen Depot, Allergopharma Inc., Reinbek, Germany |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- informed consent of patient and/or parents
- age >6 and <18 years
- bronchial asthma I° or II°
- allergy on house dust-mite
Key exclusion criteria (6 listed)
- age <6 and >18 years
- vital capacity <80% or FEV1 <70%
- pregnancy
- inhalative or systemic steroid use
- bronchial asthma III° or IV°
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 subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot)Also: Novo-Helisen Depot, Allergopharma Inc., Reinbek, GermanyWe treat each patient with mite-allergen following the two different protocols. | Biological | 1, 2 |
Primary outcome
Safety of the shortened specific immunotherapy.
Time frame: may 2004 - march 2005
1 secondary outcome
Exhaled nitric oxid (eNO) and immunogenicity (IgE, specific IgE, specific IgG) in both groups.
Time frame: may 2004 - march 2005
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 5 Oct 2007.
- Background: PubMed 12915987Hansen I, Hormann K, Stuck BA, Schneider-Gene S, Mosges R, Klimek L. [Cluster-immunotherapy in seasonal allergic rhinitis: safety aspects of induction therapy with depot allergoids (Purethal)]. Laryngorhinootologie. 2003 Aug;82(8):558-63. doi: 10.1055/s-2003-41234. German.
- Background: PubMed 15990782Tabar AI, Echechipia S, Garcia BE, Olaguibel JM, Lizaso MT, Gomez B, Aldunate MT, Martin S, Marcotegui F. Double-blind comparative study of cluster and conventional immunotherapy schedules with Dermatophagoides pteronyssinus. J Allergy Clin Immunol. 2005 Jul;116(1):109-18. doi: 10.1016/j.jaci.2005.05.005.
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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.
Stefan Zielen, M.D., Ph.D. principal investigator
Goethe University, Department of Pulmonology
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 subcutaneous immunotherapy house dust mite allergoid (Novo-Helisen Depot) in people with Immunotherapy, run by Johann Wolfgang Goethe University Hospital 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 4 inclusion and 6 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 5 Oct 2007. 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?
Safety of the shortened specific immunotherapy. (time frame: may 2004 - march 2005). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00540150, which also lists 2 linked publications.
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 5 Oct 2007.