Impact of Carrier Solutions for House Dust Mite Allergen on Allergic Reactions (NCT05245175) | Clinical Trial Compass
CompletedNot Applicable
Impact of Carrier Solutions for House Dust Mite Allergen on Allergic Reactions
Germany19 participantsStarted 2022-02-22
Plain-language summary
Single-blind, within-block randomized, clean-air-controlled study to assess the effect of lactose and sodium chloride particles in patients with allergic rhinitis on nasal symptoms when challenged in the Fraunhofer Allergen Challenge Chamber
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Able and willing to give written informed consent.
✓. Male and female subjects, aged 18-65 years. Women will be considered for inclusion if they are:
✓. Body mass index between 18 and 32 kg/m2
✓. History of HDM-induced allergic rhinitis with or without conjunctivitis of 1 year or longer in duration at screening.
✓. Positive skin prick test responses (positive wheal diameter reaction of ≥ 3 mm larger than the negative control and wheal diameter \< 2 mm to the sodium chloride/diluent negative control) to D. pteronyssinus at screening or within the past 12 months (if performed and documented at the clinical unit).
✓. Serum specific IgE level (≥ 0.7 kU/L) to D. pteronyssinus at screening or within the past 12 months (if performed and documented at the clinical unit).
✓. FEV1 of 80% of predicted value or greater at screening. If subject fails to achieve this value, the assessment may be repeated 2 additional times.
✓. Total Nasal Symptom Score (TNSS) of ≤ 3 prior to entering the chamber at visit 2.
Exclusion criteria
✕. Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urine analysis, vital signs, lung function or ECG at screening visit , which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study.
✕
What they're measuring
1
Change of mean total nasal symptom score (TNSS) during challenge over 4 hours with either lactose or sodium chloride particles compared to challenges with clean air.
Timeframe: Day 1, Day 2, Day 3
Trial details
NCT IDNCT05245175
SponsorFraunhofer-Institute of Toxicology and Experimental Medicine
✕. Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
✕. History of an acute infection at screening that has not resolved four weeks prior to visit 2.
✕. Nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyps).
✕. Concomitant allergies to seasonal aeroallergens which are anticipated to be or become active (i.e., grass, trees, weeds, rye; defined as IgE ≥ 3.5 kU/L \[IgE samples drawn within 12 months prior to screening can be used to assess criteria as long as they are performed and documented at the clinical unit\]; OR symptomatic to aeroallergens within the past 2 years or within the past 2 allergy seasons; OR both) through the completion of the study.
✕. Concomitant allergy to an animal dander who has exposure on a regular basis to the respective animal dander.
✕. History of allergic reactions such as anaphylactic shock, exanthema generalized, angioedema or hypotension caused by HDM and/or any medical products (including vaccine) in the past.