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Grass/Olive Immunotherapy for Rhinitis and Asthma (GOES)
EU CTIS ID: 2025-521709-42-00
What this study is testing
Assessment of the clinical efficacy of grass and olive AIT, evaluated by the combined symptom and medication score (0-6 collected through a mobile App) during the peak of grass and olive pollination compared with placebo after at least 8 injections of treatment.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants aged ≥6 years of age at the time of signing consent or assent.
- Participants suffering from moderate or severe allergic rhinoconjunctivitis
- Asthmatic participants must be, in the investigator’s judgement, with controlled disease according to Global Initiative on Asthma (GINA) guidelines, no severe asthma exacerbations in the previous pollen season, and have a forced expiratory volume in 1 second (FEV1) ≥70% at the time of immunotherapy administration
- Participants/legal representatives who have understood and signed the informed consent or informed assent (see Section 10.1.4).
- Participants or guardians need to have a mobile phone which can support the cSMS App and access to internet and/or mobile service.
- Participants who are able to remain at their usual place of residence for the majority of the pollen season.
You likely can't join if
- Previous treatment with any type of AIT in the previous 5 years.
- Any contraindication for treatment with SC allergen specific immunotherapy according to information of product use.
- Participants who have required systemic corticosteroids in the 12 weeks prior to the inclusion (screening) in the study.
- Participants who have previously suffered a serious secondary reaction during the skin prick test (SRs after skin prick test [SPT], which can be classified using World Allergy Organisation 2010 (WAO-2010) reactions and serious according to regulatory definition of serious adverse reaction [SAR]).
- Participants clinically unstable at the time of the inclusion (screening) in the study (acute asthmatic exacerbation, respiratory infection, febrile fever, acute urticaria, etc); rescreening is permitted (see Section 5.4).
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
See the full eligibility criteria
Who can join
- Participants aged ≥6 years of age at the time of signing consent or assent.
- Participants suffering from moderate or severe allergic rhinoconjunctivitis
- Asthmatic participants must be, in the investigator’s judgement, with controlled disease according to Global Initiative on Asthma (GINA) guidelines, no severe asthma exacerbations in the previous pollen season, and have a forced expiratory volume in 1 second (FEV1) ≥70% at the time of immunotherapy administration
- Participants/legal representatives who have understood and signed the informed consent or informed assent (see Section 10.1.4).
- Participants or guardians need to have a mobile phone which can support the cSMS App and access to internet and/or mobile service.
- Participants who are able to remain at their usual place of residence for the majority of the pollen season.
- Participants are capable of complying with the study protocol.
- Preexisting stable disease is allowed unless otherwise specified in the exclusion criteria in Section 5.2, as established by medical history and physical examination and as determined by the investigator. Preexisting stable disease is defined as not requiring significant change in therapy or hospitalisation for worsening disease during the 28 days before enrolment.
- Agree to actively stay in contact with the study site for the duration of the study for the participant’s own safety.
What rules you out
- Previous treatment with any type of AIT in the previous 5 years.
- Any contraindication for treatment with SC allergen specific immunotherapy according to information of product use.
- Participants who have required systemic corticosteroids in the 12 weeks prior to the inclusion (screening) in the study.
- Participants who have previously suffered a serious secondary reaction during the skin prick test (SRs after skin prick test [SPT], which can be classified using World Allergy Organisation 2010 (WAO-2010) reactions and serious according to regulatory definition of serious adverse reaction [SAR]).
- Participants clinically unstable at the time of the inclusion (screening) in the study (acute asthmatic exacerbation, respiratory infection, febrile fever, acute urticaria, etc); rescreening is permitted (see Section 5.4).
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
- Participants with investigator-determined chronic urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin tests will be performed, or a history of hereditary angiooedema.
- Participants with any condition that represents an absolute contraindication to the administration of adrenaline (heart disease, etc).
- Participants undergoing immunosuppressive treatment (except topical immunosuppressants).
- Participants with any other disease not associated with the moderate or severe rhinoconjunctivitis or asthma, but of potential severity and that could interfere with the treatment and follow-up (epilepsy, psychomotor deterioration, malformations, multi-operated, kidney diseases, etc).
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Sensitisation to Alternaria alternata
- Participants whose status prevents them from providing cooperation and/or who presents with severe psychiatric disorders
- Participants with known allergy to other vaccine components different from grass or olive allergen extract.
- Participants with chronic lower airway diseases other than asthma such as emphysema or bronchiectasis.
- Direct relatives of the investigator
- Sensitisation to dust mites
- Sensitisation to epithelia if the participant lives or has frequent contact with animals.
- Sensitisation to other co-seasonal allergens
- Participants receiving treatment with biologics
- Uncontrolled asthma at the time of immunotherapy administration, according to the GINA guidelines or unstable asthma
- Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy. Female participants of childbearing potential may be enrolled in the study, if the participant: -has practiced adequate contraception for 1 month prior to study intervention administration, and -has a negative pregnancy test on the first day of study intervention administration, and -has agreed to continue adequate contraception during the entire study treatment period (see Section 10.3).
- Lactating.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.