Effects of Tregalizumab on Allergen-induced Airway Responses and Airway Inflammation in Asthmatic… (NCT04673591) | Clinical Trial Compass
CompletedPhase 2
Effects of Tregalizumab on Allergen-induced Airway Responses and Airway Inflammation in Asthmatic Patients
Germany42 participantsStarted 2020-12-09
Plain-language summary
The study will be conducted as a randomized, double-blind, placebo-controlled, single-center study in adult patients with mild controlled allergic asthma and house dust mite allergy.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Willing and able to give written informed consent.
✓. Male or female subject aged 18 to 65 years (both inclusive).
✓. Established diagnosis of mild controlled allergic asthma (GINA 2019) and history of allergic bronchial asthma for at least 1 year.
✓. BMI of 18.0 to 30.0 (both inclusive).
✓. Non-smoker (all substances).
✓. Specific IgE to HDM (Dermatophagoides farinae) ≥ class 2 in radioallergosorbent test (RAST).
✓. BHR (i.e., a decrease in FEV1 of at least 20%) measured by methacholine challenge.
✓. FEV1 ≥ 75% of predicted value (according to height, weight and sex).
Exclusion criteria
✕. Severe, unstable bronchial asthma.
✕. Exacerbation of asthma ≤ 4 weeks prior to screening.
✕. Treatment with parenteral and oral corticosteroids 6 weeks prior to screening and during the study.
✕. Treatment with inhaled corticosteroids, methylxanthines (e.g., theophyllin), anticholinergics (e.g., ipratropium bromide), leukotriene modifiers (e.g., montelukast), tiotropium bromide, cromolyn or nedocromil within 2 weeks prior to screening and during the study.
✕
What they're measuring
1
Baseline-corrected late asthmatic response measured by the area under the curve for the forced expiratory volume (FEV1) at 4 to 7 hours after bronchial allergen provocation