Allergic RhinoconjunctivitisPhase 2/3NCT00824447
Long-term Efficacy and Safety Study With Oralgen Grass Pollen
A Phase 2/3 study testing Oralgen in people with Allergic Rhinoconjunctivitis, run by Artu Biologicals at 39 sites in 7 countries.
Trial summary
This study is designed to give additional information on the efficacy, safety and local effects (tolerability) of a dose of sublingual immunotherapy administered once a day, during a second grass pollen season. Read more about this study
- Who is it for?
- Ages 18 to 51 years
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- What is being tested?
- Oralgen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 356 participants
- Where
- 39 sitesin 7 countries
- Study dates
- Aug 2007to Jan 2009
- Phase
- Phase 2/3
- 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 51 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients who meet the in and exclusion criteria for study AB0602 and successfully finished this study.
- Patients who have given their written consent to participate in this study.
- Patients who are willing to comply with the protocol and understand the information given.
- Female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method.
- Negative urine pregnancy test if female at the end of the previous study.
Who cannot join
- Pregnancy, breast-feeding / lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.
- Patients who were non-compliant during study AB0602.
- Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or the outcome of this study.
Trial locations and contacts
39 sites in 7 countries.
39 sites in 7 countries
Czechia9 sites
ORL Soukroma praxe
Brno
Fakultni nemocnice Brno
Brno-Bohunice
Nemocnice Caslav
Čáslav
Alergologicka ordinace
Dobruška
Alergologicka ambulance
Jablonec nad Nisou, 466 04
Alergologicka ordinace
Kutná Hora, 284 01
Alergologicka ambulance
Ostrava - Hrabuvka
Ambulance plicni a alergologicka
Ostrave - Hrabuvka
Alergologicka ambulance Okresni nemocnice Tabor
Tábor
Bulgaria7 sites
MHAT PLovdiv, ENT Clinic
Plovdiv
Military Medical Academy, Clinic of ENT
Sofia, 1606
Military Medical Academy
Sofia, 1606
5th MHAT, ENT Clinic
Sofia
Ministry of interior-central clinical database
Sofia
MHAT Sveta Marina
Varna
Military Medical Academy
Varna
Germany6 sites
Berufsgen. kliniken Bergmannsheil
Bochum
Univ. klinikum Carl Gustav Carus
Dresden
MedicoKIT
Goch
Johannes-Gutenberg-Universitat Mainz
Mainz
Vital Care
München
Privataertz. inst. & Forsh. einrichtung
Wiesbaden
Hungary5 sites
Svabhegyi Allami Gyermekgyogyintezet pulmonologia
Budapest
Szent Janos Korhaz
Budapest
Selye Janos Korhaz
Komárom
Karolina Korhaz
Mosomagyarovar
Tudogyogyintezet Torokbalint
Törökbálint
Lithuania4 sites
Kaunas medical University hospital
Kaunas
JSC Seimos gydytojas
Vilnius
Vilnius Central Outpatient Clinic
Vilnius
Vilnius university hospital, Santariskiu Clinic
Vilnius
Netherlands4 sites
Ampha Den Bosch / Regio Brabant
's-Hertogenbosch, 5233 VG
Ampha De Bilt
De Bilt, 3731 DN
Ampha
Hengelo
AMPHA Nijmegen
Nijmegen, 6525EC
Slovakia4 sites
Centrum imunologie a alergologie s.r.o
Bratislava
Amb. klinickey imunologie a allergologie UTaRCH
Poprad
Ambulancia klinickej imunologie a alergologie
Trenčín
Medcentrum s.r.o.
Žilina
About this study
Official title: A Randomised, DB, Plcb Controlled, Multicentre, Multinat. Phase II/III FU Study to Assess Longterm Efficacy and Safety of 3 Different Dose Regimens of Oralgen® GrassPollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis
This study is designed to give additional information on the efficacy, safety and local effects (tolerability) of a dose of sublingual immunotherapy administered once a day, during a second grass pollen season.
Read the detailed description
Allergy is one of the most common chronic diseases. Allergies to grass, weed, and tree pollens characteristically result in seasonal rhinitis symptoms commonly termed hay fever. The risk of developing asthma has been noted to be higher in patients with rhinitis than among the general population (10% versus 3.6%), confirming the fact that rhinitis is often the first step of the natural history of asthma.
Although several drugs effectively manage the symptoms of allergic rhinitis, conjunctivitis or asthma, they do not represent an etiopathogenic treatment of the considered diseases, and do not prevent the reappearance of the symptoms at the end of the treatment.
Immunotherapy is generally considered to be appropriate for patients in whom rhinitis symptoms cannot be controlled by an optimal medication regimen and avoidance of the allergens. At present, specific immunotherapy is the only therapy available that acts on the main cause of the allergic reaction by modifying or down-regulating the immune response.
Allergen immunotherapy is the administration of gradually increasing quantities of an allergen vaccine (extract) to an allergic subject, to reach a maintenance dose, which is effective in reducing the symptoms associated with exposure to the causative allergen.
- Conditions
- Allergic Rhinoconjunctivitis
- Being tested
- Oralgen, placebo
- Keywords
- randomised, double-blind, placebo-controlled, long-term efficacy and safety, Oralgen® Grass Pollen, allergic rhinoconjunctivitis, Allergy, Rhinoconjunctivitis, Immunotherapy, Grass pollen extract
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OralgenDrug
Also called grasspollen extract
allergen solution sublingually
placeboOther
Also called Placebo control
placebo control
| Study group | Role | What they receive |
|---|---|---|
| Placebo control | Placebo comparator | Placebo control Receives: Other: placebo |
| Grass pollen extract, twice weekly | Active comparator | Grass pollen extract, 9,500 BU, given twice weekly Receives: Drug: Oralgen |
| Grass pollen extract daily | Active comparator | Grass pollen extract, 9,500 BU, given daily Receives: Drug: Oralgen |
| Increased dose of grass pollen extract | Active comparator | Increased dose of grass pollen extract, 19,000 BU, given daily Receives: Drug: Oralgen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pollen Season Rhinoconjunctivitis Total Symptom Score
Measured: site specific pollen season
Secondary outcomes (5)
Rescue medication usage
Measured: one year
Proportion of symptom-free days during the pollen season
Measured: one year
Rhinoconjunctivitis QoL Questionnaire
Measured: one year
Global evaluation of the efficacy by the patient
Measured: one year
Local and systemic tolerability and other adverse events, labor
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startAug 2007
- Primary completionAug 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artu Biologicals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dyonne van Duren, MD, PhD, Principal investigator, AMPHA Nijmegen, Toernooiveld 220, 6525EC, Nijmegen, The NetherlandsKnut Schaekel, MD, PhD, Principal investigator, Universitait Klinikum Carl Gustav Carus, Fetscherstrasse 74, SN 01307, Dresden, GermanyIveta Kozlovska, MD, PhD, Principal investigator, Centrum Immunologie a allergologie, Pavla Horova 14, 84108 Bratislava, Slovak Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824447
- Sponsor's protocol ID
- AB0602/1
- Other IDs
- 2007-002477-31
- Status last verified
- May 2010
- First submitted
- 15 Jan 2009
- Last updated
- 5 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, DB, Plcb Controlled, Multicentre, Multinat. Phase II/III FU Study to Assess Longterm Efficacy and Safety of 3 Different Dose Regimens of Oralgen® GrassPollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT00824447
- Acronym / sponsor ID
- AB0602/1
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- randomised, double-blind, placebo-controlled, long-term efficacy and safety, Oralgen® Grass Pollen, allergic rhinoconjunctivitis, Allergy, Rhinoconjunctivitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Artu BiologicalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 16 Jan 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.
This study is designed to give additional information on the efficacy, safety and local effects (tolerability) of a dose of sublingual immunotherapy administered once a day, during a second grass pollen season.
Detailed description
Allergy is one of the most common chronic diseases. Allergies to grass, weed, and tree pollens characteristically result in seasonal rhinitis symptoms commonly termed hay fever. The risk of developing asthma has been noted to be higher in patients with rhinitis than among the general population (10% versus 3.6%), confirming the fact that rhinitis is often the first step of the natural history of asthma.
Although several drugs effectively manage the symptoms of allergic rhinitis, conjunctivitis or asthma, they do not represent an etiopathogenic treatment of the considered diseases, and do not prevent the reappearance of the symptoms at the end of the treatment.
Immunotherapy is generally considered to be appropriate for patients in whom rhinitis symptoms cannot be controlled by an optimal medication regimen and avoidance of the allergens. At present, specific immunotherapy is the only therapy available that acts on the main cause of the allergic reaction by modifying or down-regulating the immune response.
Allergen immunotherapy is the administration of gradually increasing quantities of an allergen vaccine (extract) to an allergic subject, to reach a maintenance dose, which is effective in reducing the symptoms associated with exposure to the causative allergen.
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 |
|---|---|---|
| Placebo control | Placebo comparator | Other: placeboPlacebo control |
| Grass pollen extract, twice weekly | Active comparator | Drug: OralgenGrass pollen extract, 9,500 BU, given twice weekly |
| Grass pollen extract daily | Active comparator | Drug: OralgenGrass pollen extract, 9,500 BU, given daily |
| Increased dose of grass pollen extract | Active comparator | Drug: OralgenIncreased dose of grass pollen extract, 19,000 BU, given daily |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients who meet the in and exclusion criteria for study AB0602 and successfully finished this study.
- Patients who have given their written consent to participate in this study.
- Patients who are willing to comply with the protocol and understand the information given.
- Female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method.
- Negative urine pregnancy test if female at the end of the previous study.
Key exclusion criteria (3 listed)
- Pregnancy, breast-feeding / lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.
- Patients who were non-compliant during study AB0602.
- Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or the outcome of this study.
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 |
|---|---|---|
| OralgenAlso: grasspollen extractallergen solution sublingually | Drug | Grass pollen extract daily, Grass pollen extract, twice weekly, Increased dose of grass pollen extract |
| placeboAlso: Placebo controlplacebo control | Other | Placebo control |
Primary outcome
Pollen Season Rhinoconjunctivitis Total Symptom Score
Time frame: site specific pollen season
5 secondary outcomes
Rescue medication usage
Time frame: one year
Proportion of symptom-free days during the pollen season
Time frame: one year
Rhinoconjunctivitis QoL Questionnaire
Time frame: one year
Global evaluation of the efficacy by the patient
Time frame: one year
Local and systemic tolerability and other adverse events, labor
Time frame: one year
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 May 2010.
Related trials for Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
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Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df
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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.
Dyonne van Duren, MD, PhD principal investigator
AMPHA Nijmegen, Toernooiveld 220, 6525EC, Nijmegen, The Netherlands
Knut Schaekel, MD, PhD principal investigator
Universitait Klinikum Carl Gustav Carus, Fetscherstrasse 74, SN 01307, Dresden, Germany
Iveta Kozlovska, MD, PhD principal investigator
Centrum Immunologie a allergologie, Pavla Horova 14, 84108 Bratislava, Slovak Republic
39 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oralgen in people with Allergic Rhinoconjunctivitis, run by Artu Biologicals at 39 sites in 7 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 5 inclusion and 3 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 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Czechia, Bulgaria, Germany, Hungary, Lithuania and 2 more countries. 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 combined 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.
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?
Pollen Season Rhinoconjunctivitis Total Symptom Score (time frame: site specific pollen season). 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 5 May 2010.