Evaluation of tolerability and efficacy of subcutaneous cluster-immunotherapy in patients with allergic rhinitis / rhino-conjunctivitis due to grass polle

Phase 1

• Conditions: Allergic rhinitis / rhino-conjunctivitis; MedDRA version: 19.0Level: LLTClassification code 10001726Term: Allergic rhinitis due to pollenSystem Organ Class: 100000004870; MedDRA version: 19.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2010-022083-12-DE
• Lead Sponsor: ROXALL Medizin GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-28
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 <2 mm) and
- a clear positive result to the histamine control (wheal diameter =3 mm) and
- presence of specific IgE against timothy pollen (positive CAP EAST class II and above) and
- a positive reaction after nasal provocation with a timothy allergen concentration of <=1,666 BU/mL and
- anti-allergic or anti-asthmatic treatment during the previous grass pollen season
•An RRTSS during the previous pollen season of greater than or equal to nine
•Compliance and ability of the patient to follow the instructions of the study stuff for the nasal provocation test (NPT)
•Safety laboratory results within the normal range or out of normal range but considered as not clinically significant

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 87
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified