Allergic Asthma, Allergic Conjunctivitis of Both Eyes, Allergic Rhinitis Due to Grass Pollen
Conditions
Keywords
Allergen immunotherapy, Allergic rhinoconjunctivitis, grass pollen allergy, intralymphatic immunotherapy, ILIT.NU
Brief summary
Investigation of the clinical efficacy of 3 intralymphatic injections with grass pollen extract into inguinal lymph nodes on combined symptom-medication scores during grass pollen season in grass pollen allergic patients compared to placebo
Detailed description
A double-blind, parallel group, placebo controlled multi-site trial of the clinical efficacy of 3 intralymphatic injections with a low dose of grass pollen extract into inguinal lymph nodes in grass pollen allergic subjects. Primary endpoint is the difference in combined symptom and medication score during grass pollen seasons following treatment compared with patients receiving placebo. Injections are giving ultrasound-guided with at least 4 weeks intervals. To increase trial retention, two studies within the trial are conducted: a feasibility study assessing the acceptability and feasibility of a digital intervention and its evaluation design. Outcomes include participant and stakeholder acceptability, reach, mechanisms of change to improve trial retention, utilization, unintended effects, software functionality, recruitment and retention rates, questionnaire suitability, randomization feasibility, power for a future definitive trial, and initial efficacy signals. Additionally, an evaluation study assesses the efficacy of the intervention.
Interventions
DRUGGrass pollen extract - Alutard Phleum pratense, ALK
injection in lymph node
Sponsors
University of Aarhus
University Hospital, Linkoeping
Aarhus University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The study is run in a double-blind design
Intervention model description
parallel group, double blind placebo controlled multi site
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* moderate-severe grass pollen allergic rhinoconjunctivitis * positive skin prick test for grass pollen extract
Exclusion criteria
* significant mugwort allergy * previous AIT for grass pollen allergy * uncontrolled non-allergic upper airways disease * uncontrolled asthma * planned depot steroid injections during season * uncontrolled autoimmune diseases * active malignancies * uncontrolled other severe condition, including psychiatric diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined symptom and medication score, cSMS | 2 years | daily combined symptom and medication scores during grass pollen seasons in 2022 and 2023 as compared to placebo. cSMS is a combined score of a symptom score, 0-3, where 0 indicates no symptoms and 3 indicates severe symptoms and meddication score 0-3 according to the us of reliever medication: 0: no medication, 1: antihistamine use, 2: local steroid use, 3: systemic steroid use. This results in a score ranging from 0 (no symptoms, no need for medications) to 6 (severe symptoms and need for maximum reliever medication |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| side-effects | 3 months | occurence of side-effects as compared to placebo |
| correlation of CSMS to pollen count | 2 years | correlate cSMS to daily pollen counts |
| combined symptom and medication score, cSMS | 2 years | change in the combined symptom and medication score from baseline |
| Rhinitis related quality of life, RQLQ | 2 years | changes on rhinitis related quality of life |
| Airwave oscillometry system(AOS), asthma | 2 years | Influence of ILIT on resistance in the lower airways measured by AOS |
Countries
Denmark, Sweden
Outcome results
None listed