Allergic rhinitis / rhino-conjunctivitis MedDRA version: 19.0 Level: LLT Classification code 10001726 Term: Allergic rhinitis due to pollen System Organ Class: 100000004870 MedDRA version: 19.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853
Conditions
Interventions
Product Name: CLUSTOID Wiesenlieschgras
Product Code: CLUSTOID Wiesenlieschgras
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: CLUSTOID Wiesenlieschgras
Other descriptive name: Mod
Sponsors
ROXALL Medizin GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Signed and dated patient's informed consent obtained prior to any study specific examination •Female or male patients aged 18–75 with allergic rhinitis and/or allergic rhinoconjunctivitis with or without seasonal controlled allergic asthma [The Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2010, http://www.ginasthma.org] •Clinically relevant allergy to grass pollen for at least 2 consecutive years •The sensitization to other aero-allergens and/or to mites, cats and dogs, has to be considered as not clinically relevant or that the allergic symptoms do not interfere with the study •Positive clinical history of grass pollen, verified by: - positive screening skin prick test (SPT) against timothy pollen (wheal diameter =3 mm) and - a clear negative result to the negative control (max. wheal diameter =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: •Previous immunotherapy with grass pollen extracts from the homologous group of grass and cereal pollen according to Annex 1 in the Guideline on allergen products: production and quality issues (EMEA/CHMP/BWP/304831/2007) within the last 5 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 judgment (e.g. expected poor compliance) •Active tuberculosis •Patients with hypersensitivity to excipients of the investigational medicinal product •Any significant abnormal laboratory parameters or alteration in the vital signs that could increase the risk for the study patient •Diseases of the immune system including autoimmune and immune deficiencies •Immunosuppressive therapy •Severe chronic inflammatory diseases •Acute or chronic inflammatory or infectious airway diseases including recurrent acute or chronic sinusitis •Malignancy during the previous 5 years •Alcohol, drug, or medication abuse within the past year •Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection •Irreversible secondary disorders at the target organs (e.g. emphysema, bronchoectasis) •Systemic and local (eyedrops) treatment with beta-blockers •Use of tranquillizers or psychoactive drugs within 1 week prior to Visit 1 •Use of systemic corticosteroids within 3 months prior to Visit 1 •Immunization with vaccines within 7 days prior to Visit 1 •Patients treated with other contra-indicated drugs (cf. section 11.2) •Partly controlled or uncontrolled asthma according to the Global Initiative for Asthma (GINA) Guideline, e.g. PEF or FEV1-value <80% of the predicted normal values calcula-ted by regression formulas (ERS EGKS 1993) according to: www.vitalograph.de/spirometry_normal_values_guidelines.php •Inflammation and infect of the target organs (e.g. nose, eyes, lung) •Contra-indication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension, hyperthyroidism) •Completed or ongoing long-term treatment with tranquilizer or psycho active drugs •Completed or ongoing treatment with anti-IgE-antibody •Suspected inability to understand instructions/ study documents •Severe psychiatric, psychological, or neurological disorders •Patients being in any relationship or dependence with the Sponsor and/or investigator •Nursing (lactating) women or a positive pregnancy test at Visit 1 •Patients who are not contractually capable •Persons who are jurisdictional or governmentally institutionalized
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objective: to assess the tolerability and safety of the treatment using four different concentrations for subcutaneous immunotherapy with cluster-allergoid CLUSTOID® Wiesenlieschgras.;Timepoint(s) of evaluation of this end point: 6 month after start of the study.;Main Objective: Primary objective: to assess the efficacy of four different concentrations for subcutaneous immunotherapy with cluster-allergoid CLUSTOID® Wiesenlieschgras by means of the threshold concentration that is needed to provoke an allergic response after titrated nasal provocation with increasing concentrations of an allergen extract of Phleum pratense.;Primary end point(s): The primary objective is to assess the efficacy of four different concentrations for subcutaneous immunotherapy with cluster-allergoid CLUSTOID® Wiesenlieschgras by means of determining the threshold concentration that is needed to provoke a positive allergic response after nasal provocation with escalating concentrations of an allergen extract of Phleum pratense. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objective is to assess the tolerability and safety of four different concentrations for subcutaneous immunotherapy with cluster allergoid CLUSTOID® Wiesenlieschgras.;Timepoint(s) of evaluation of this end point: 6 month after start of the study. | — |
Countries
Germany
Contacts
Public ContactROXALL Medizin GmbH
ROXALL Medizin GmbH
Outcome results
None listed