Ongoing Clinical Trials for Hypersensitivity

This article provides information about 5 ongoing clinical trials investigating new treatments and diagnostic approaches for hypersensitivity reactions. These studies are testing various antihistamine medications, allergen extracts for skin testing, and new treatment formulations across Spain and Sweden.

Clinical trial locations

• Spain
  • Study comparing bilastine, ebastine, and desloratadine in preventing histamine-induced skin reactions in healthy volunteers
  • Study on Allergenic Extracts of Mites and Histamine Dihydrochloride for Allergy Patients
  • Study on the Effectiveness of Dermatophagoides Allergen Extracts and Histamine Dihydrochloride for Patients with Allergies
  • Study on the Effectiveness of Dermatophagoides Allergen Extracts for Allergy Patients Using Dermatophagoides Pteronyssinus and Dermatophagoides Farinae Solutions
• Sweden
  • Study on Dexamethasone Film for Patients with Acute Allergic Reactions

Study on the Effectiveness of Dermatophagoides Allergen Extracts for Allergy Patients Using Dermatophagoides Pteronyssinus and Dermatophagoides Farinae Solutions

This trial is investigating allergen extracts derived from dust mites to improve allergy testing methods. The study focuses on two specific types of dust mites that commonly cause allergic reactions in household environments.

Main inclusion criteria: Participants must be adults between 18 and 50 years old living in areas where these dust mites are common, such as the Mediterranean coast. You need to have a confirmed allergy to Dermatophagoides pteronyssinus, demonstrated through both a positive skin prick test and a positive specific IgE blood test. Your skin must also show an appropriate reaction to histamine testing, producing a wheal of at least 4 mm. All participants must understand the study requirements and provide informed consent.

Main exclusion criteria: People with known allergies to the test substances cannot participate. The study excludes those outside the specified age range and individuals considered part of vulnerable populations, such as pregnant women or those unable to provide proper consent.

Study focus: The trial uses skin-prick tests to standardize the biological response to dust mite allergen extracts. Researchers will measure the size of skin reactions (wheals) produced by different concentrations of the extracts compared to histamine and saline controls. The study is conducted in two phases: first determining the appropriate concentration of the Dermatophagoides pteronyssinus extract, then assessing how accurately the extract identifies people with and without allergies.

Investigational treatments: The study uses Dermatophagoides pteronyssinus extract and Dermatophagoides farinae extract, both derived from different species of dust mites. These extracts are being tested to determine the proper dosage that produces consistent and measurable allergic responses during skin testing.

Study comparing bilastine, ebastine, and desloratadine in preventing histamine-induced skin reactions in healthy volunteers

This study compares three different antihistamine medications to determine how quickly and effectively they prevent allergic skin reactions. The medications being tested all come in dissolving tablet form that can be placed on the tongue.

Main inclusion criteria: Healthy volunteers between 18 and 50 years old can participate. You must have normal medical examination results, including blood tests and vital signs. Your body mass index must be between 18.5 and 30.0 kg/m². Women of childbearing potential must use barrier contraception methods during the study. Your skin must show a specific range of reaction to histamine testing. You must avoid excessive sun exposure and procedures that could change your skin color before and during the study.

Main exclusion criteria: You cannot participate if you have a history of severe allergic reactions or anaphylaxis, are currently using antihistamine medications, or are allergic to any of the study drugs. Pregnant or breastfeeding women are excluded. People with significant medical conditions, particularly chronic respiratory or cardiovascular disease, liver or kidney problems, or mental health conditions cannot join. Recent participation in other clinical trials also excludes you from this study.

Study focus: The trial examines how quickly bilastine 20 mg, ebastine 10 mg, and desloratadine 5 mg begin working to prevent histamine-induced skin reactions. Each participant will receive all three medications and placebo at different times, with appropriate waiting periods between treatments. Researchers will measure the size of skin reactions and blood drug levels at multiple time points to understand the onset, duration, and strength of each medication’s effects.

Investigational treatments: The study tests three antihistamine medications: bilastine, ebastine, and desloratadine. All three medications work by blocking histamine receptors, thereby preventing allergic symptoms. They are provided as orodispersible tablets that dissolve quickly in the mouth without requiring water.

Study on Allergenic Extracts of Mites and Histamine Dihydrochloride for Allergy Patients

This trial examines allergen extracts from four different types of mites to improve and standardize allergy testing procedures. The study will help determine the biological potency of these extracts when used in skin-prick tests.

Main inclusion criteria: Adults between 18 and 65 years old who have a confirmed history of allergies can participate. You must show sensitivity to the specific allergens being tested, demonstrated by either a positive skin prick test (reaction at least 3 mm in size compared to negative control) or a specific IgE blood test result of 3.5 kUA/L or higher. These tests must have been performed within the last 18 months. Women of childbearing potential must have a negative pregnancy test. All participants must provide informed consent.

Main exclusion criteria: People with allergies to the test substances cannot participate. The study has specific age restrictions and may exclude individuals based on certain gender-specific health issues. Vulnerable populations requiring special protection or care are not eligible.

Study focus: The study uses skin-prick testing to measure the biological activity of extracts from Dermatophagoides pteronyssinus, Dermatophagoides farinae, Blomia tropicalis, and Lepidoglyphus destructor mites. Researchers apply these extracts to the skin and measure the resulting wheal size to assess the potency of each extract in Histamine Equivalent Units. The study also monitors for any adverse reactions to ensure safety.

Investigational treatments: Four different mite allergen extracts are being tested: Dermatophagoides pteronyssinus extract, Dermatophagoides farinae extract, Blomia tropicalis extract, and Lepidoglyphus destructor extract. Each extract is evaluated for its ability to produce measurable skin reactions in allergic individuals.

Study on Dexamethasone Film for Patients with Acute Allergic Reactions

This trial evaluates patient satisfaction with a new formulation of dexamethasone that dissolves in the mouth, making it easier to take during acute allergic reactions.

Main inclusion criteria: You must be at least 18 years old and have previously experienced acute allergic reactions. To participate, you need to be currently prescribed betamethasone tablets for treating your allergic reactions. You must be willing and able to provide written informed consent, meaning you understand the study and agree to participate.

Main exclusion criteria: People experiencing an acute allergic reaction at the time of enrollment cannot participate. An acute allergic reaction is a sudden and severe response that can cause symptoms like swelling, difficulty breathing, or rashes.

Study focus: The study assesses patient satisfaction with Zeqmelit™ 6 mg mouth-dissolving film compared to usual treatment methods. Participants will use the medication when experiencing acute allergic reactions and provide feedback on their overall satisfaction, feelings of safety, perceived effectiveness, and ease of use. The study gathers real-world information about patient experiences with this new treatment formulation.

Investigational treatments: Zeqmelit™ is a 6 mg dexamethasone mouth-dissolving film designed to work quickly to relieve allergy symptoms such as itching, swelling, and difficulty breathing. The dissolving film format makes it easy to take without water, which can be particularly helpful during acute allergic reactions.

Study on the Effectiveness of Dermatophagoides Allergen Extracts and Histamine Dihydrochloride for Patients with Allergies

This trial aims to standardize the biological response to allergen extracts from two common dust mite species, helping to improve the accuracy and consistency of allergy testing.

Main inclusion criteria: Participants must be adults between 18 and 50 years old living in areas where Dermatophagoides pteronyssinus and Dermatophagoides farinae are common, such as humid, mild climates like the Mediterranean coast. You must have confirmed allergies to these dust mites, demonstrated by both a positive skin prick test (showing a reaction at least 3 mm larger than the negative control) and a positive specific IgE blood test (class 1 or higher). Your skin must also show an adequate reaction to histamine testing, producing a wheal of at least 4 mm. You must understand the study’s purpose and sign an informed consent form.

Main exclusion criteria: People with known allergies to the test substances cannot participate. Children under 3 years old and individuals considered part of vulnerable groups requiring extra care or protection are excluded from the study.

Study focus: The study uses skin-prick testing to determine how different concentrations of dust mite allergen extracts affect skin reactions. Researchers measure the size of wheals (raised areas on the skin) produced by the extracts and compare them to histamine and saline controls. This helps establish the dose-response relationship and standardize the biological activity of the extracts. The trial also monitors for any adverse reactions to assess safety.

Investigational treatments: The study tests Dermatophagoides pteronyssinus allergen extract and Dermatophagoides farinae allergen extract, both administered through intradermal injection. These extracts are being evaluated to establish standardized concentrations for reliable allergy testing and potential immunotherapy applications.

Summary

Currently, 5 clinical trials are investigating various aspects of hypersensitivity treatment and diagnosis. The majority of these studies are concentrated in Spain, with 4 trials examining allergen extracts for improved allergy testing and one trial comparing different antihistamine medications. Sweden hosts one trial focused on patient satisfaction with a new treatment formulation for acute allergic reactions.

A notable focus across multiple Spanish trials is the standardization of dust mite allergen extracts, particularly from Dermatophagoides pteronyssinus and Dermatophagoides farinae species. Three separate studies are working to establish reliable testing methods using these extracts, reflecting the importance of these allergens in the Mediterranean region. The antihistamine comparison study in Spain represents a different approach, examining how quickly bilastine, ebastine, and desloratadine begin working to prevent allergic reactions in healthy volunteers.

The Swedish trial takes a patient-centered approach, evaluating satisfaction with Zeqmelit™, a mouth-dissolving dexamethasone film designed for easier administration during acute allergic reactions. This study emphasizes the importance of treatment convenience and patient experience alongside clinical effectiveness.

These trials collectively address both diagnostic improvements through allergen extract standardization and therapeutic advances through new formulations and comparative effectiveness studies. The research may lead to more accurate allergy testing methods and better treatment options for people experiencing hypersensitivity reactions.