Actively Recruiting
Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomized Placebo-controlled Double-blind Study
Led by Wroclaw Medical University · Updated on 2025-01-28
67
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
Sponsors
W
Wroclaw Medical University
Lead Sponsor
A
ALL-MED Medical Research Institute, Wroclaw, Poland
Collaborating Sponsor
AI-Summary
What this Trial Is About
The main objective of the study is to measure and correlate clinical parameters suitable for the assessment of allergen immunotherapy (AIT) with an aluminum hydroxide-adsorbed preparation of house dust mite (Dermatophagoides pteronyssinus/ Dermatophagoides farinae) allergens in adults with moderate to severe allergic rhinitis/rhinoconjunctivitis with or without controlled allergic bronchial asthma caused by house dust mite (HDM) allergens. The assessment of clinical responses will be evaluated following an allergen challenge in allergen exposure chamber (AEC) before and during the course of AIT. Patients' response to therapy will be evaluated as well as in the AEC and by patient's personal environment (Diary).
CONDITIONS
Official Title
Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomized Placebo-controlled Double-blind Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent given before any trial activities
- Male or female outpatient aged 18 to 65 years
- Moderate to severe allergic rhinitis or rhinoconjunctivitis caused by house dust mite allergens confirmed by positive skin prick test and specific IgE
- Symptoms present for at least 2 years including October to February or year-round
- Persistent moderate to severe rhinitis symptoms for at least 4 consecutive weeks and 4 days per week, impacting daily activities or sleep
- Regular need for anti-symptomatic medication
- Previous anti-allergic medication use for at least 2 seasons
- No asthma diagnosis or well-controlled asthma according to guidelines at trial entry
You will not qualify if you...
- Unable to understand or comply with trial requirements
- Participation in another clinical trial within 30 days before consent
- Low adherence expected or unable to understand trial instructions
- Involved in trial planning or dependent on investigator
- Previously randomized in this trial
- Mentally disabled or institutionalized
- Pregnant, breastfeeding, or unwilling to use effective contraception if female with childbearing potential
- History of anaphylaxis after allergen immunotherapy injection
- Currently receiving or received allergen immunotherapy for house dust mite or unknown allergens within 5 years
- Symptoms from other perennial or seasonal allergens affecting assessment period except cat or dog allergens without direct contact
- Chronic or non-allergic respiratory symptoms
- Chronic rhinitis symptoms lasting 20 years or more
- Lung function below 70% predicted despite asthma treatment
- Uncontrolled or partly controlled asthma
- Asthma exacerbation in past 6 months requiring systemic steroids or hospitalization
- Severe acute or chronic diseases including infections, autoimmune or inflammatory diseases
- Severe psychiatric disorders or substance abuse
- Recurrent seizures or irreversible lung damage
- Laboratory abnormalities beyond normal reference ranges
- Use of beta-blockers or ACE inhibitors
- Contraindications for adrenaline use
- Use of anti-IgE, anti-IL4/IL13 antibodies, or other immunomodulatory drugs
- Long-term treatment with tranquilizers or psychoactive drugs
AI-Screening
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Trial Site Locations
Total: 1 location
1
ALL-MED Medical Research Institute
Wroclaw, DL, Poland, 53-201
Actively Recruiting
Research Team
M
Marek M Jutel, prof.
CONTACT
M
Magdalena E Zemelka-Wiacek, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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