Allergic RhinitisPhase 2NCT00973453
Study With High Dose PURETHAL Mites in Allergic Rhinitis/Rhinoconjunctivitis Patients
A Phase 2 study testing PURETHAL Mites 20,000 AUeq/ml in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by HAL Allergy at 6 sites in Germany.
Trial summary
The aim of the study is to establish the maximum tolerated dose of PURETHAL Mites that is achieved by 90% of the patients with less than 20% of the injections giving rise to a swelling of > 5 cm and the optimal regimen to reach this maximum dose will be determined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- What is being tested?
- PURETHAL Mites 20,000 AUeq/ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 6 sitesGermany
- Study dates
- Aug 2009to Aug 2010
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with perennial rhinitis or rhinoconjunctivitis, with or without mild asthma (FEV1 > 70%) for at least 2 years. with allergic symptoms related to HDM
- Positive CPT test to HDM Der p, dose ≤10,000 AUeq/ml
- Positive SPT to HDM Der p or Der f (mean wheal diameter ≥ 3mm)
- Specific serum IgE-test (ssIgE > 0.7 U/ml) for HDM
- Age ≥ 18 years
- Written informed consent given
Who cannot join
- Patients with concomitant sensitization i.e. positive SPT (mean wheal diameter ≥ 3 mm) to other allergens than HDM should not be included if they have clinical symptoms at the time of inclusion, related to the other allergen
- Patients sensitized to pets should not be included if they live together with these pets or have clinical symptoms
- Immunotherapy (including sublingual) with HDM within the last 5 years
- Immunotherapy (including sublingual) during the study period
- Chronic asthma or emphysema, particularly with a FEV1 ≤ 70% of predicted value or use of inhalation corticosteroids
- Serious immuno-pathologic diseases or malignancies (including auto-immune diseases, tuberculosis)
Show all 19Show fewer
- Symptomatic coronary heart diseases or severe (even under treatment) arterial hypertension
- Diseases with a contra-indication for the use of adrenaline
- Patients who are using other aluminium preparations, e.g. antacids
- Severe kidney disease
- Use of systemic steroids
- Treatment with systemic and local Beta-blockers or immunosuppressive drugs
- Active infection of the target organs (nose or eyes)
- Severe atopic dermatitis in case systemic immunosuppressive medication is used
- Participation in a clinical study with a new investigational drug within the last 3 months
- Pregnancy, lactation or inadequate contraceptive measures (adequate contraceptive measures will be the use of a contraceptive device or -pill)
- Alcohol- or drug abuse
- Lack of co-operation or severe psychological disorders
- Institutionalisation by official or judicial order
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Allergie-Centrum Charité, Klinik für Dermatologie, Venerologie und Allergologie, Charité Campus Mitte, Universitätsmedizin Berlin
Berlin, D-10117
Hals, Nasen- und Ohrenheilkunde
Berlin, D-13057
Allergy & Asthma Center Westend
Berlin, D-14050
Universitätsklinikum Düsseldorf
Düsseldorf, D-40225
Allergologie HNO-Heilkunde
Schorndorf, D-73614
Klinik für Dermatologie und Allergie, Krankenhaus Bad Cannstatt
Stuttgart, D-70374
About this study
Official title: Dose Tolerability Study With High Dose PURETHAL Mites in Allergic Rhinitis / Rhinoconjunctivitis Patients
The aim of the study is to establish the maximum tolerated dose of PURETHAL Mites that is achieved by 90% of the patients with less than 20% of the injections giving rise to a swelling of > 5 cm and the optimal regimen to reach this maximum dose will be determined.
Read the detailed description
The tolerability and safety of three different initial treatment regimens PURETHAL mites in patients with allergic rhinitis / rhinoconjunctivitis induced by house dust mites will be evaluated and the optimal regimen to reach the maximum tolerated dose will be determined. The maximum intended dose is a 4-fold dosage compared to the currently used maintenance dose of PURETHAL Mites. The tolerability and safety of the injections will be examined by means of determining the early and late local and systemic reactions. In addition, short-term efficacy of this high dose PURETHAL mites will be determined by means of the Clinical index score (CIS) and two surrogate efficacy markers; the conjunctival provocation test (CPT) and serum levels of allergen specific immunoglobulins (IgG and IgE). These efficacy parameters are purely indicative and not decisive for the further clinical development of PURETHAL Mites.
- Conditions
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- Being tested
- PURETHAL Mites 20,000 AUeq/ml
- Keywords
- non-seasonal allergy, house dust mite, immunotherapy, dose tolerability
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PURETHAL Mites 20,000 AUeq/mlDrug
Also called Immunotherapy for house dust mites allergy
Group 1: slow regimen (12+2 injections) Initial treatment: incremental weekly dose of 0.05, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.8, 1.0, 1.2*, 1.6* and 2.0* ml Additional maintenance: 2 two-weekly injections 2.0* ml
*Injection volumes larger than 1 ml will be given as 2 separate injections of equal volume within an area of 1 cm.
PURETHAL Mites 20,000 AUeq/mlDrug
Also called Immunotherapy for house dust mites allergy
Group 2: intermediate regimen (9+2 injections) Initial treatment: incremental weekly dose of 0.1, 0.2, 0.4, 0.6, 0.8, 1.0, 1.2*, 1.6* and 2.0* ml.
Additional maintenance: 2 two-weekly injections 2.0* ml
*Injection volumes larger than 1 ml will be given as 2 separate injections of equal volume within an area of 1 cm.
PURETHAL Mites 20,000 AUeq/mlDrug
Also called Immunotherapy for house dust mites allergy
Group 3: fast initial treatment (6+2 injections) Initial treatment: incremental weekly dose of 0.2, 0.4, 0.8, 1.2*, 1.6* and 2.0*ml.
Additional maintenance: 2 two-weekly injections 2.0* ml
*Injection volumes larger than 1 ml will be given as 2 separate injections of equal volume within an area of 1 cm.
| Study group | Role | What they receive |
|---|---|---|
| Slow regimen | Other | Not described Receives: Drug: PURETHAL Mites 20,000 AUeq/ml |
| Intermediate regimen | Other | Not described Receives: Drug: PURETHAL Mites 20,000 AUeq/ml |
| Fast regimen | Other | Not described Receives: Drug: PURETHAL Mites 20,000 AUeq/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Local Reactions (ELR) occurring 15 minutes after injection. Less than 20% of the injections should give rise to swelling at the injection site of > 5 cm in diameter occurring 15 minutes after injection.
Measured: 17, 14 or 11 weeks per patient for the respective groups
Secondary outcomes (5)
Late Local Reactions (LLR) occurring within 24 hours after injection, and systemic reactions (SR). General adverse events will be recorded during complete study period.
Measured: 17, 14 or 11 weeks per patient for the respective groups
Clinical index score (CIS) during the study compared to baseline score (before treatment).
Measured: weekly during per patient treatment periods of 17, 14 or 11 weeks for the respective groups
Conjunctival provocation test one week after reaching 10,000 AUeq, 20,000 AUeq, or 40,000 AUeq for the respective groups compared to baseline.
Measured: after 7 weeks of treatment
Conjunctival provocation test 2 weeks after the patients have received two maintenance dosages compared to baseline score.
Measured: 17, 14 or 11 weeks for the respective treatment groups
Specific IgE and IgG measured 2 weeks after the patients have received two maintenance dosages compared to baseline score.
Measured: 17, 14 or 11 weeks for the respective treatment groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- HAL Allergy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jörg Kleine-Tebbe, MD, Study chair, UZDAA, Untersuchungszentrum Dermatologie, Allergologie und Asthma, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973453
- Sponsor's protocol ID
- PM/0028
- Status last verified
- Sep 2011
- First submitted
- 7 Sep 2009
- Last updated
- 12 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Tolerability Study With High Dose PURETHAL Mites in Allergic Rhinitis / Rhinoconjunctivitis Patients
- ClinicalTrials.gov ID
- NCT00973453
- Acronym / sponsor ID
- PM/0028
- Conditions
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- Keywords
- non-seasonal allergy, house dust mite, immunotherapy, dose tolerability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- HAL AllergyIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 9 Sep 2009 (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.
The aim of the study is to establish the maximum tolerated dose of PURETHAL Mites that is achieved by 90% of the patients with less than 20% of the injections giving rise to a swelling of > 5 cm and the optimal regimen to reach this maximum dose will be determined.
Detailed description
The tolerability and safety of three different initial treatment regimens PURETHAL mites in patients with allergic rhinitis / rhinoconjunctivitis induced by house dust mites will be evaluated and the optimal regimen to reach the maximum tolerated dose will be determined. The maximum intended dose is a 4-fold dosage compared to the currently used maintenance dose of PURETHAL Mites. The tolerability and safety of the injections will be examined by means of determining the early and late local and systemic reactions. In addition, short-term efficacy of this high dose PURETHAL mites will be determined by means of the Clinical index score (CIS) and two surrogate efficacy markers; the conjunctival provocation test (CPT) and serum levels of allergen specific immunoglobulins (IgG and IgE). These efficacy parameters are purely indicative and not decisive for the further clinical development of PURETHAL Mites.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Slow regimen | Other | Drug: PURETHAL Mites 20,000 AUeq/ml |
| Intermediate regimen | Other | Drug: PURETHAL Mites 20,000 AUeq/ml |
| Fast regimen | Other | Drug: PURETHAL Mites 20,000 AUeq/ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with perennial rhinitis or rhinoconjunctivitis, with or without mild asthma (FEV1 > 70%) for at least 2 years. with allergic symptoms related to HDM
- Positive CPT test to HDM Der p, dose ≤10,000 AUeq/ml
- Positive SPT to HDM Der p or Der f (mean wheal diameter ≥ 3mm)
- Specific serum IgE-test (ssIgE > 0.7 U/ml) for HDM
- Age ≥ 18 years
Key exclusion criteria (19 listed)
- Patients with concomitant sensitization i.e. positive SPT (mean wheal diameter ≥ 3 mm) to other allergens than HDM should not be included if they have clinical symptoms at the time of inclusion, related to the other allergen
- Patients sensitized to pets should not be included if they live together with these pets or have clinical symptoms
- Immunotherapy (including sublingual) with HDM within the last 5 years
- Immunotherapy (including sublingual) during the study period
- Chronic asthma or emphysema, particularly with a FEV1 ≤ 70% of predicted value or use of inhalation corticosteroids
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 |
|---|---|---|
| PURETHAL Mites 20,000 AUeq/mlAlso: Immunotherapy for house dust mites allergyGroup 1: slow regimen (12+2 injections) Initial treatment: incremental weekly dose of 0.05, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.8, 1.0, 1.2*, 1.6* and 2.0* ml Additional maintenance: 2 two-weekly injections 2.0* ml *Injection volumes larger than 1 ml will be given as 2 separate injections of equal volume within an area of 1 cm. | Drug | Slow regimen |
| PURETHAL Mites 20,000 AUeq/mlAlso: Immunotherapy for house dust mites allergyGroup 2: intermediate regimen (9+2 injections) Initial treatment: incremental weekly dose of 0.1, 0.2, 0.4, 0.6, 0.8, 1.0, 1.2*, 1.6* and 2.0* ml. Additional maintenance: 2 two-weekly injections 2.0* ml *Injection volumes larger than 1 ml will be given as 2 separate injections of equal volume within an area of 1 cm. | Drug | Intermediate regimen |
| PURETHAL Mites 20,000 AUeq/mlAlso: Immunotherapy for house dust mites allergyGroup 3: fast initial treatment (6+2 injections) Initial treatment: incremental weekly dose of 0.2, 0.4, 0.8, 1.2*, 1.6* and 2.0*ml. Additional maintenance: 2 two-weekly injections 2.0* ml *Injection volumes larger than 1 ml will be given as 2 separate injections of equal volume within an area of 1 cm. | Drug | Fast regimen |
Primary outcome
Early Local Reactions (ELR) occurring 15 minutes after injection. Less than 20% of the injections should give rise to swelling at the injection site of > 5 cm in diameter occurring 15 minutes after injection.
Time frame: 17, 14 or 11 weeks per patient for the respective groups
5 secondary outcomes
Late Local Reactions (LLR) occurring within 24 hours after injection, and systemic reactions (SR). General adverse events will be recorded during complete study period.
Time frame: 17, 14 or 11 weeks per patient for the respective groups
Clinical index score (CIS) during the study compared to baseline score (before treatment).
Time frame: weekly during per patient treatment periods of 17, 14 or 11 weeks for the respective groups
Conjunctival provocation test one week after reaching 10,000 AUeq, 20,000 AUeq, or 40,000 AUeq for the respective groups compared to baseline.
Time frame: after 7 weeks of treatment
Conjunctival provocation test 2 weeks after the patients have received two maintenance dosages compared to baseline score.
Time frame: 17, 14 or 11 weeks for the respective treatment groups
Specific IgE and IgG measured 2 weeks after the patients have received two maintenance dosages compared to baseline score.
Time frame: 17, 14 or 11 weeks for the respective treatment groups
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 12 Sep 2011.
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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.
Jörg Kleine-Tebbe, MD study chair
UZDAA, Untersuchungszentrum Dermatologie, Allergologie und Asthma, Berlin, Germany
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PURETHAL Mites 20,000 AUeq/ml in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by HAL Allergy at 6 sites 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 6 inclusion and 19 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 12 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 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?
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?
Early Local Reactions (ELR) occurring 15 minutes after injection. Less than 20% of the injections should give rise to swelling at the injection site of > 5 cm in diameter occurring 15 minutes after injection. (time frame: 17, 14 or 11 weeks per patient for the respective groups). 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 12 Sep 2011.