This clinical trial will evaluate the benefit of subcutaneous cluster immunotherapy with cluster-allergoid CLUSTOID® over placebo in patients with allergic rhinoconjunctivits.
Conditions
Interventions
Product Name: CLUSTOID
Pharmaceutical Form: Suspension for injection
Sponsors
ROXALL Medizin GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients aged 18–75 with allergic rhinitis and/or allergic rhinoconjunctivitis with or without seasonal mild or moderate allergic asthma (GINA I and GINA II). • Positive clinical history of grass pollen. • Clinical sensitization to grass with or without additional sensitization to rye pollen. • Compliance and ability of the patient to complete a Diary Card • Signed and dated patient´s informed consent form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Previous immunotherapy with grass or rye pollen extracts within the last 3 years, • Predominant perennial allergic rhinitis, • Predominant perennial allergic asthma, • Simultaneous participation in other clinical trials, • Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance), • Active tuberculosis, • Auto-immune disorders, • Severe chronic-inflammatory diseases, • Malignancy, • Alcohol abuse, • Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection, • Irreversible secondary disorders at the target organ (e.g. emphysema, bronchoectasis), • Patients treated with ?-blockers and/or other contra-indicated drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of a subcutaneous cluster immunotherapy with cluster-allergoid CLUSTOID® on a total combined score (TCS), taking into account a rhinoconjunctivitis total symptom score (RTSS) of the six rhinoconjunctivitis symptoms sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes and a total rescue medication score (TRMS), considering the use of cromone eye drops, oral antihistamines, nasal corticosteroids and leukotriene antagonists.;Secondary Objective: To assess the efficacy of a subcutaneous cluster immunotherapy with cluster-allergoid CLUSTOID® on the rhinoconjunctivitis symptom scores (RSS) sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes for the peak of the grass and rye pollen season and the global evaluation carried out by the patient for the total grass and rye pollen season and to document and assess the safety of the treatment. ;Primary end point(s): The efficacy is to be evaluated by assessing the mean in the total combined score (TCS), taking into account the RTSS and the TMRS, during the peak pollen season. | — |
Countries
Germany
Outcome results
None listed