Allergic RhinoconjunctivitisPhase 2/3NCT00567346
Efficacy and Safety of Grass Pollen Sublingual Immunotherapy
A Phase 2/3 study testing Oralgen and grass pollen extract in people with Allergic Rhinoconjunctivitis, run by Artu Biologicals at 40 sites in 7 countries.
Trial summary
The study is assessing efficacy and safety of three different dosage regimens of grass pollen sublingual immunotherapy in adult patients suffering from grass pollen related rhinoconjunctivitis. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Allergic Rhinoconjunctivitis
- What is being tested?
- Oralgen and grass pollen extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 605 participants
- Where
- 40 sitesin 7 countries
- Study dates
- Dec 2006to Mar 2008
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- male or female aged 18-50
- patients with grass pollen related allergic rhinoconjunctivitis for at least 2 pollen seasons
- Positive skin prick test and IgE value of at least Class 2+
- RTSS of greater or equal to 14 during pollen season prior tot the start of the study
- Patients must be in general good health
- Patients with normal spirometry
Show all 9Show fewer
- Informed consent given and willing to comply with the protocol
- Female patients are eligible if they use an accepted contraceptive method
- Negative urine pregnancy test if female
Who cannot join
- Pregnancy, breast feeding
- Asthma requiring treatment other than beta-2 inhaled agonists
- patients who have taken oral steroids within 12 weeks before screening visit
- patients who have received desensitisation treatment for grass pollen
- treatment by immunotherapy with any other allergen within the previous 5 years
- patients who have suffered a lower respiratory tract infection within 4 weeks or an upper respiratory tract infection within 2 weeks of the screening visit
Show all 15Show fewer
- patients at risk of non-compliance
- participation in any other clinical study within the previous 3 months
- patients with a past or current disease, which may affect participation in or outcome of this study.
- patients treated with beta-blockers or under continuous corticotherapy
- allergic sensitivity to epithelial allergens the patients is exposed to
- positive skin prick test for environmental allergens and suffering from serious allergic symptoms due to exposure to these allergens during study period
- intention to subject the patient to surgery of the nasal cavity during current study
- Usual contraindications of immunotherapy
- a clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to tree pollen or weed pollen adjacent to the start of, and potentially overlapping the grass pollen season
Trial locations and contacts
40 sites in 7 countries.
40 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
Alergologicka ordinace
Kutná Hora
Alergologicka ambulance
Ostrava - Hrabuvka
Ambulance plicni a alergologicka
Ostrave - Hrabuvka
Alergologicka ambulance Okresni nemocnice Tabor
Tábor
Bulgaria6 sites
MHAT PLovdiv, ENT Clinic
Plovdiv
5th MHAT, ENT Clinic
Sofia
Military Medical Academy
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
Lithuania5 sites
Kaunas medical University hospital
Kaunas
Klaipeda Regional Hospital
Klaipėda
JSC Seimos gydytojas
Vilnius
Vilnius Central Outpatient Clinic
Vilnius
Vilnius university hospital, Santariskiu Clinic
Vilnius
Slovakia5 sites
Centrum imunologie a alergologie s.r.o
Bratislava
FNsP Nove Zamky, ambulancia TaRCh
Nové Zámky
Amb. klinickey imunologie a allergologie UTaRCH
Poprad
Ambulancia klinickej imunologie a alergologie
Trenčín
Medcentrum s.r.o.
Žilina
Netherlands4 sites
Ampha
's-Hertogenbosch
Ampha
De Bilt
Ampha
Hengelo
Menox
Nijmegen
About this study
Official title: A Randomised, DB, Plcb Controlled, Multicentre, Multinational Phase II/III Study to Assess the Efficacy and Safety of Three Different Dose Regimens of Oralgen Grass Pollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis
The study is assessing efficacy and safety of three different dosage regimens of grass pollen sublingual immunotherapy in adult patients suffering from grass pollen related rhinoconjunctivitis.
Read the detailed description
Patients with seasonal grass pollen related rhinoconjunctivitis will be randomized to one of four treatment groups at 41 centres in Europe. Each treatment group will consist of approximately 150 patients and 150 patients will be randomized to a placebo group. The study will consist of a screening phase, a treatment phase and a variable maintenance period.
- Conditions
- Allergic Rhinoconjunctivitis
- Being tested
- Oralgen, grass pollen extract
- Keywords
- randomised, double-blind, placebo-controlled, 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 grass pollen extract
Patients will receive drops of grass pollen immunotherapy sublingually
grass pollen extractDrug
Also called Placebo control
Patients will receive matching placebo sublingually
| Study group | Role | What they receive |
|---|---|---|
| grass pollen extract twice weekly | Active comparator | Current standard dose regimen of grass pollen immunotherapy (9,500 BU), given twice weekly. Note: patients in twice weekly dosing regimen will also receive placebo on days no active treatment is given. Receives: Drug: Oralgen |
| Grass pollen extract, daily | Active comparator | Grass pollen immunotherapy, 9,500 BU, given daily Receives: Drug: Oralgen |
| Increased dose of grass pollen extract | Active comparator | Increased dose of grass pollen immunotherapy, 19,000 BU, given daily Receives: Drug: Oralgen |
| Placebo control | Placebo comparator | Patients randomized to placebo will receive placebo daily. Receives: Drug: grass pollen extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS)
Measured: One year
Secondary outcomes (1)
Diarised Period RTSS on severity of rhinoconjunctivitis scores and rescue medication usage will be calculated to assess efficacy. Safety will be assessed through AE profile, the assessment of routine safety tests.
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 posted4 Dec 2007 (estimated)
- Study startDec 2006
- Primary completionOct 2007
- Study completionMar 2008
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artu Biologicals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Folkert R Roossien, Study director, Artu-Biologicals Europe B.V., the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567346
- Sponsor's protocol ID
- AB0602
- Other IDs
- 2006-001548-30
- Status last verified
- May 2010
- First submitted
- 3 Dec 2007
- Last updated
- 5 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
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, Multinational Phase II/III Study to Assess the Efficacy and Safety of Three Different Dose Regimens of Oralgen Grass Pollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT00567346
- Acronym / sponsor ID
- AB0602
- Conditions
- Allergic Rhinoconjunctivitis
- Keywords
- randomised, double-blind, placebo-controlled, efficacy and safety, Oralgen® Grass Pollen, allergic rhinoconjunctivitis, Allergy, Rhinoconjunctivitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- Artu BiologicalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 4 Dec 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.
The study is assessing efficacy and safety of three different dosage regimens of grass pollen sublingual immunotherapy in adult patients suffering from grass pollen related rhinoconjunctivitis.
Detailed description
Patients with seasonal grass pollen related rhinoconjunctivitis will be randomized to one of four treatment groups at 41 centres in Europe. Each treatment group will consist of approximately 150 patients and 150 patients will be randomized to a placebo group. The study will consist of a screening phase, a treatment phase and a variable maintenance period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| grass pollen extract twice weekly | Active comparator | Drug: OralgenCurrent standard dose regimen of grass pollen immunotherapy (9,500 BU), given twice weekly. Note: patients in twice weekly dosing regimen will also receive placebo on days no active treatment is given. |
| Grass pollen extract, daily | Active comparator | Drug: OralgenGrass pollen immunotherapy, 9,500 BU, given daily |
| Increased dose of grass pollen extract | Active comparator | Drug: OralgenIncreased dose of grass pollen immunotherapy, 19,000 BU, given daily |
| Placebo control | Placebo comparator | Drug: grass pollen extractPatients randomized to placebo will receive placebo daily. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- male or female aged 18-50
- patients with grass pollen related allergic rhinoconjunctivitis for at least 2 pollen seasons
- Positive skin prick test and IgE value of at least Class 2+
- RTSS of greater or equal to 14 during pollen season prior tot the start of the study
- Patients must be in general good health
Key exclusion criteria (15 listed)
- Pregnancy, breast feeding
- Asthma requiring treatment other than beta-2 inhaled agonists
- patients who have taken oral steroids within 12 weeks before screening visit
- patients who have received desensitisation treatment for grass pollen
- treatment by immunotherapy with any other allergen within the previous 5 years
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: grass pollen extractPatients will receive drops of grass pollen immunotherapy sublingually | Drug | Grass pollen extract, daily, Increased dose of grass pollen extract, grass pollen extract twice weekly |
| grass pollen extractAlso: Placebo controlPatients will receive matching placebo sublingually | Drug | Placebo control |
Primary outcome
Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS)
Time frame: One year
1 secondary outcome
Diarised Period RTSS on severity of rhinoconjunctivitis scores and rescue medication usage will be calculated to assess efficacy. Safety will be assessed through AE profile, the assessment of routine safety tests.
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
Allergic Rhinoconjunctivitis
Recruiting
Creating A Risk Assessment Tool for Thunderstorm Asthma: the CARISTA Study
Allergic Asthma, Thunderstorm Asthma
RecruitingPhase 3
Efficacy and Safety of SLIT in Patients With Rhinitis/RC With/Without Mild-moderate Asthma, Due to Dpt and/or Df
Rhinitis, Rhinoconjunctivitis
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.
Folkert R Roossien study director
Artu-Biologicals Europe B.V., the Netherlands
40 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 and grass pollen extract in people with Allergic Rhinoconjunctivitis, run by Artu Biologicals at 40 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 9 inclusion and 15 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 40 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?
Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS) (time frame: One year). 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.