Allergic rhinitis MedDRA version: 21.1 Level: PT Classification code 10039085 Term: Rhinitis allergic System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: PT Classification code 10010744 Term: Conjunctivitis allergic System Organ Class: 10015919 - Eye disorders MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Alutard SQ phleum pratense (ALK 225)
Product Name: Alutard SQ phleum pratense (ALK 225)
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injecti
Sponsors
Aarhus Universitet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients have seasonal grass pollen induced rhino conjunctivitis during the two most recent seasons and a positive skin prick test resulting in a wheal diameter = 3 mm to ALK Soluprick Grass 225. The latter is important as it predicts that the patients IgE recognises allergens found in ALKs preparation for treatment, a crucial condition for treatment success. Patients are adults; more than 18 years old on the day of first treatment, Patients must be comfortable with digital data entry and have accepted and digitally approved the informed consent document. Patient have to have sufficient symptoms during the grass pollen season to allow us to record an effect of the treatment; we will evaluate question 1 – 6 and 18 – 22 of their RHINE III and the sum of the retrospective RTSS questionnaires from the pre-screening tools to assess the severity of grass pollen dependent rhinoconjunctivitis and to identify or predict possible grass pollen dependent asthma affecting patients. For inclusion, patients have to have a retrospective RTSS score >7 on a scale of 0 – 18 (most severe). We will select patients with the highest RTSS score. 90% of patients included for the baseline year will be included in the treatment study. 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 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 11
Exclusion criteria
Exclusion criteria: pregnancy 1 previous allergen immunotherapy for grass pollen allergy 2 Significant allergic sensitisation to mugwort (Artemisia vulgaris) or sensitisation with persistent exposure to pet animal allergens that results in allergic symptoms 3 Known or suspected allergy to additives to the study product; allergy to aluminium hydroxide or phenol 4 Depot steroid injection for treatment of allergic rhinoconjunctivitis 5 Upper airway disease (non-allergic sinusitis, nasal polyps) 6 uncontrolled asthma or severe asthma with post bronchodilator FEV1<70% of expected, decided by the investigator 7 Pulmonary disease, perennial or seasonal with daily use of more than 800 microgram inhaled budesonide/ day (or equivalent) or treatment with omalizumab or other biologics for allergy or asthma. 8 Pulmonary disease with post bronchodilator FEV1 < 70 % of predicted 9 Allergic reaction within the last 4 days or anaphylaxis last month before ILIT injections 10 severe Autoimmune or collagen disease 11 Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with beta-blockers) 12 Known cardiovascular disease, i.e. not even NYHA class I. 13 Use of ACE-blockers. If ACE-blockers are used, they should be withdrawn after discussion with the Principal Investigator 2 weeks before first injection and until after the last injection 14 Recent or on-going hepatic or renal disease 15 All malignant diseases 16 Immuno- or chemotherapy during the last 15 years, 17 Increased bleeding tendency 18 Any other than study medication with an effect of interfering with the immune response 19 Chronic obstructive or restrictive lung disease 20 Skin diseases with barrier defect in the inguinal areas 21 Alcohol or drug abuse 22 Participation in another clinical study from visit 1-8.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the trial is to provide statistically significant data supporting the safety and clinical efficacy of intralymphatic immunotherapy compared to placebo in relieving medication use and symptoms during the grass pollen seaso;Secondary Objective: A second aim is to determine whether ILIT limits grass pollen allergic asthma of treated patients by asking asthma related questions and measuring airway reactivity by acoustic oscillometry. ;Primary end point(s): The primary endpoint is a reduction of more than 20% in the annual median combined symptom medication score (cSMS) on a scale from 0 – 6, suggested by EAACI, over the allergen season defined by EAACI in patients treated with Alutard compared with patients treated with placebo.;Timepoint(s) of evaluation of this end point: Change in parameters from the pollen season before treatment to the season after treatment and the second season after treatment. Change in parameters between groups in the grass pollen season after treatment, as well as in the second season after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Effect of treatment quality (nr of successful injections) on treatment effect in cSMS the importance of patient engagement for quality of cSMS data cSMS can also be interpreted also as Well days and Hell days , and as response to Log10 of daily grass pollen counts The predictive ability of the skin prick test as a ratio of the histamine positive control (Cha) for cSMS 1 Effect of treatment with ILIT on patients with asthma as assessed with ACT and with AOS In patients without asthma we will monitor small airway changes with AOS ;Timepoint(s) of evaluation of this end point: Change in parameters from the pollen season before treatment to the season after treatment and the second season after treatment. | — |
Countries
Denmark, Sweden
Contacts
Public ContactHans Jürgen Hoffmann
Aarhus University, Department of Clinical Medicine
Outcome results
None listed