Allergic RhinitisPhase 2NCT01438463
PURETHAL® Mites Dose Range Finding Study in Patients With Persistent Allergic Rhinitis/Rhinoconjunctivitis
A Phase 2 study testing PURETHAL Mites 6,667 AU/ml, PURETHAL Mites 20,000 AU/ml and PURETHAL Mites 50,000 AU/ml in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by HAL Allergy at 35 sites in 5 countries.
Trial summary
The objective of the present study is to characterize the dose-response relationship of PURETHAL® Mites with a nasal provocation test in order to support the optimal dose in terms of clinical efficacy and safety. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- What is being tested?
- PURETHAL Mites 6,667 AU/ml, PURETHAL Mites 20,000 AU/ml and PURETHAL Mites 50,000 AU/ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- 35 sitesin 5 countries
- Study dates
- Sep 2011to May 2013
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent
- Patients (male or female) must be ≥ 18 and ≤ 60 years at screening
- Patients with allergic rhinitis or rhinoconjunctivitis for at least 1 year; allergic symptoms related to HDM, with or without concomitant clinically stable controlled mild to moderate asthma (according to GINA classification)
- Patients with a history of concomitant asthma should have a FEV1 > 70% at inclusion. Patients without a history of asthma should have a FEV1 > 70% or a PEF > 80%.
- Positive SPT to HDM D. pter and/or D. far
- Serum specific IgE-test (ssIgE) level for HDM D. pter or D. far at screening
- Positive nasal provocation test for HDM extract at screening
Who cannot join
- Current clinically relevant symptoms of seasonal rhinitis/rhinoconjunctivitis caused by other allergen(s) than HDM (with a demonstrated positive SPT for this allergen) at the time of inclusion
- Patients sensitized to animals should not be included if they are symptomatic upon exposure and regularly exposed to animals
- Completed allergen-specific immunotherapy (SCIT or SLIT) with HDM within the last 5 years
- Completed unsuccessful allergen-specific immunotherapy (SCIT or SLIT) within the past 5 years
- Allergen-specific immunotherapy (SCIT or SLIT) with other allergens than HDM during the study period
- Any vaccination one week before start of therapy and during the up-dosing phase
Show all 23Show fewer
- Any anti-IgE therapy within the last 6 months prior to inclusion and during study
- Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs
- Active malignancies or any malignant disease in the past 5 years
- A chronic or acute disease that in the opinion of the investigator might place the patient at an additional risk, including but not limited to the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine disorders, clinically significant renal or hepatic diseases, or haematological disorders
- Moderate to severe nasal obstructive diseases such as polyps, septal deviations etc.
- Clinically significant chronic sinusitis or ocular infection
- Diseases with a contra-indication for the use of adrenaline (e.g. hyperthyroidism, glaucoma)
- Use of systemic corticosteroids within 4 weeks of screening
- Treatment with systemic or local b-blockers
- Participation in a clinical study with a new investigational drug within the last 3 months or a biological within the last 6 months prior to the study or during the study
- Pregnancy, lactation or inadequate contraceptive measures (contraceptive measures considered as adequate include appropriate use of oral contraception, i.m. contraception or a contraceptive device)
- Alcohol, drug, or medication abuse within the past year and during study
- Any abnormal laboratory parameter at screening that in the opinion of the investigator is considered clinically relevant
- Lack of co-operation or compliance
- Severe psychiatric, psychological, or neurological disorders
- Patients who are employees of the department, 1st grade relatives, or partners of the investigator
- Expected changes in HDM exposure during the study (avoidance measures, move, etc.)
Trial locations and contacts
35 sites in 5 countries.
35 sites in 5 countries
Germany22 sites
HNO-Praxis Dr. Hippke
Berlin, D-13057
Universitätsklinikum Bonn
Bonn, D-53127
HNO-Praxis
Chemnitz, D-09130
Gemeinschaftspraxis Pneumologie und Allergologie Dr. Hans-Christian Blum
Dortmund, D-44263
HNO-Praxis Dr. U. Thieme
Duisburg, D-47051
Medizinisches Versorgungszentrum
Düren, D-52351
Universitätsklinikum Erlangen
Erlangen, D-91052
HNO Gemeinschaftspraxis
Göttingen, D-37073
Pneumologische Praxis Hannover Nordstadt
Hanover, D-30167
HNO Gemeinschaftspraxis
Heidelberg, D-69126
HNO-Praxis
Jülich, D-52428
POIS Leipzig GbR
Leipzig, D-04357
CRS Clinical Research Services Mannheim GmbH
Mannheim, D-68167
CRS Clinical Research Services Möchengladbach GmbH
Mönchengladbach, D-41061
Gemeinschaftspraxis HNO/Allergologie
München, D-80331
Klinikum der Universität München
München, D-80337
Pneumologie Odeonsplatz
München, D-80539
HNO-Praxis
Pirna, D-01796
Praxisgemeinschaft Reiber & Partner
Schorndorf, D-73614
Universitätsklinikum Stuttgart
Stuttgart, D-70374
Hautarztpraxis
Stuttgart, D-70499
Zentrum für Rhinologie und Allergologie
Wiesbaden, D-65183
Netherlands5 sites
EB FlevoResearch
Almere Stad, NL-1311 RL
Allergologie Praktijk Arnhem (APA)
Arnhem, NL-6824 BJ
Albert Schweitzer (Amstelwijck)
Dordrecht, NL-3317 NM
QPS Onderzoekskliniek Universitair Medisch Centrum Groningen
Groningen, NL-9713 GZ
St. Elisabethziekenhuis
Tilburg, NL-5022 GC
Belgium3 sites
UZ Gent
Ghent, B-9000
UZ Leuven campus Sint Rafaël
Leuven, B-3000
CHU de Liège
Liège, B-4000
Spain3 sites
Hospital Clinico Barcelona
Barcelona, 08036
Hospital Universitario Germans Trios i Pujol
Barcelona, 08916
Hospital Universitari Politecnic La Fe
Valencia, 46026
Austria2 sites
Univ.-Klinik für Dermatologie und Venerologie
Innsbruck, A-6020
Universitätsklinik für Hals -, Nasen - und Ohrenheilkunde
Innsbruck, A-6020
About this study
Official title: A Multi-centre, Randomized, Double-blind, Placebo-controlled, Dose Range Finding Study to Identify the Optimal Dose of PURETHAL® Mites SCIT in Patients With House Dust Mites-induced Persistent Allergic Rhinitis/Rhinoconjunctivitis
The objective of the present study is to characterize the dose-response relationship of PURETHAL® Mites with a nasal provocation test in order to support the optimal dose in terms of clinical efficacy and safety.
For this purpose 5 groups of 50 patients, suffering from rhinitis or rhinoconjunctivitis due to House Dust Mite Allergy will be treated during 1 year. Before start, after 6 months of treatment and at the end of the study patients will be subjected to a nasal provocation test.
- Conditions
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- Being tested
- Placebo, PURETHAL Mites 6,667 AU/ml, PURETHAL Mites 20,000 AU/ml, PURETHAL Mites 50,000 AU/ml, PURETHAL Mites 100,000 AU/ml
- Keywords
- non-seasonal allergy, house dust mite, immunotherapy, dose response
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
Increasing volumes of placebo, will be administered by subcutaneous injection (starting with 0.05 ml) at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of placebo, are given at 4-weekly intervals.
PURETHAL Mites 6,667 AU/mlBiological
Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.
PURETHAL Mites 20,000 AU/mlBiological
Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.
PURETHAL Mites 50,000 AU/mlBiological
Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.
PURETHAL Mites 100,000 AU/mlBiological
Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Biological: Placebo |
| PURETHAL Mites, 6,667 AU/ml | Experimental | Not described Receives: Biological: PURETHAL Mites 6,667 AU/ml |
| PURETHAL Mites, 20,000 AU/ml | Experimental | Not described Receives: Biological: PURETHAL Mites 20,000 AU/ml |
| PURETHAL Mites, 50,000 AU/ml | Experimental | Not described Receives: Biological: PURETHAL Mites 50,000 AU/ml |
| PURETHAL Mites, 100,000 AU/ml | Experimental | Not described Receives: Biological: PURETHAL Mites 100,000 AU/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity to House Dust Mite (HDM) allergen assessed by a Nasal Provocation Test
Measured: 12 months
Secondary outcomes (5)
Sensitivity to HDM allergen assessed by a Nasal Provocation Test
Measured: 6 months
Average Adjusted daily Symptom Score (AAdSS)
Measured: last 2 months of treatment
Peak Nasal Inspiratory Flow (PNIF)
Measured: at each visit during 1 year treatment
Specific serum IgE, IgG, and IgG4 immunoglobulin concentrations to house dust mite
Measured: 6 and 12 months treatment
Local and systemic reactions after injection as a measure of Safety and Tolerability
Measured: 24 hours after each injection during 1 year treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2013
- Study completionMay 2013
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- HAL Allergy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claus Bachert, PhD, MD, Study chair, University Gent, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438463
- Sponsor's protocol ID
- PM/0037
- Status last verified
- May 2013
- First submitted
- 20 Sep 2011
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomized, Double-blind, Placebo-controlled, Dose Range Finding Study to Identify the Optimal Dose of PURETHAL® Mites SCIT in Patients With House Dust Mites-induced Persistent Allergic Rhinitis/Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT01438463
- Acronym / sponsor ID
- PM/0037
- Conditions
- Allergic Rhinitis, Allergic Rhinoconjunctivitis
- Keywords
- non-seasonal allergy, house dust mite, immunotherapy, dose response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- HAL AllergyIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 22 Sep 2011 (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 objective of the present study is to characterize the dose-response relationship of PURETHAL® Mites with a nasal provocation test in order to support the optimal dose in terms of clinical efficacy and safety.
For this purpose 5 groups of 50 patients, suffering from rhinitis or rhinoconjunctivitis due to House Dust Mite Allergy will be treated during 1 year. Before start, after 6 months of treatment and at the end of the study patients will be subjected to a nasal provocation test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Biological: Placebo |
| PURETHAL Mites, 6,667 AU/ml | Experimental | Biological: PURETHAL Mites 6,667 AU/ml |
| PURETHAL Mites, 20,000 AU/ml | Experimental | Biological: PURETHAL Mites 20,000 AU/ml |
| PURETHAL Mites, 50,000 AU/ml | Experimental | Biological: PURETHAL Mites 50,000 AU/ml |
| PURETHAL Mites, 100,000 AU/ml | Experimental | Biological: PURETHAL Mites 100,000 AU/ml |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signed informed consent
- Patients (male or female) must be ≥ 18 and ≤ 60 years at screening
- Patients with allergic rhinitis or rhinoconjunctivitis for at least 1 year; allergic symptoms related to HDM, with or without concomitant clinically stable controlled mild to moderate asthma (according to GINA classification)
- Patients with a history of concomitant asthma should have a FEV1 > 70% at inclusion. Patients without a history of asthma should have a FEV1 > 70% or a PEF > 80%.
- Positive SPT to HDM D. pter and/or D. far
Key exclusion criteria (23 listed)
- Current clinically relevant symptoms of seasonal rhinitis/rhinoconjunctivitis caused by other allergen(s) than HDM (with a demonstrated positive SPT for this allergen) at the time of inclusion
- Patients sensitized to animals should not be included if they are symptomatic upon exposure and regularly exposed to animals
- Completed allergen-specific immunotherapy (SCIT or SLIT) with HDM within the last 5 years
- Completed unsuccessful allergen-specific immunotherapy (SCIT or SLIT) within the past 5 years
- Allergen-specific immunotherapy (SCIT or SLIT) with other allergens than HDM during the study period
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 |
|---|---|---|
| PlaceboIncreasing volumes of placebo, will be administered by subcutaneous injection (starting with 0.05 ml) at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of placebo, are given at 4-weekly intervals. | Biological | placebo |
| PURETHAL Mites 6,667 AU/mlIncreasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals. | Biological | PURETHAL Mites, 6,667 AU/ml |
| PURETHAL Mites 20,000 AU/mlIncreasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals. | Biological | PURETHAL Mites, 20,000 AU/ml |
| PURETHAL Mites 50,000 AU/mlIncreasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals. | Biological | PURETHAL Mites, 50,000 AU/ml |
| PURETHAL Mites 100,000 AU/mlIncreasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals. | Biological | PURETHAL Mites, 100,000 AU/ml |
Primary outcome
Sensitivity to House Dust Mite (HDM) allergen assessed by a Nasal Provocation Test
Time frame: 12 months
5 secondary outcomes
Sensitivity to HDM allergen assessed by a Nasal Provocation Test
Time frame: 6 months
Average Adjusted daily Symptom Score (AAdSS)
Time frame: last 2 months of treatment
Peak Nasal Inspiratory Flow (PNIF)
Time frame: at each visit during 1 year treatment
Specific serum IgE, IgG, and IgG4 immunoglobulin concentrations to house dust mite
Time frame: 6 and 12 months treatment
Local and systemic reactions after injection as a measure of Safety and Tolerability
Time frame: 24 hours after each injection during 1 year treatment
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 29 May 2013.
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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.
Claus Bachert, PhD, MD study chair
University Gent, Belgium
35 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PURETHAL Mites 6,667 AU/ml, PURETHAL Mites 20,000 AU/ml and PURETHAL Mites 50,000 AU/ml in people with Allergic Rhinitis and Allergic Rhinoconjunctivitis, run by HAL Allergy at 35 sites in 5 countries.
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 7 inclusion and 23 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 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Germany, Netherlands, Belgium, Spain, Austria. 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. 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?
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?
Sensitivity to House Dust Mite (HDM) allergen assessed by a Nasal Provocation Test (time frame: 12 months). 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 29 May 2013; AzTrials last refreshed its copy on 28 Oct 2026.