Impact of Carrier Solutions for House Dust Mite Allergen on Allergic Reactions

NCT05245175 | Completed

• 1 other identifier: 22-05 SIMBA
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Allergic Rhinitis

Keywords

Allergen Challenge Chamber; House dust mite; Sodium chloride

Outcome Measures

Primary Outcomes (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.

  TNSS = Total Nasal Symptom Score (min = 0 = no symptoms; max = 12 = max symptoms)

  Day 1, Day 2, Day 3

Secondary Outcomes (2)

• Change of mean VAS of symptoms during challenge over 4 hours with either lactose or sodium chloride particles compared to challenges with clean air

  Day 1, Day 2, Day 3

• Difference in nasal secretion weight during challenge over 4 hours with either lactose or sodium chloride particles compared to challenges with clean air

  Day 1, Day 2, Day 3

Other Outcomes (2)

• Change of mean total nasal symptom score (TNSS) during challenge over 4 hours with either HDM allergen with lactose particles compared to challenges with HDM allergen with sodium chloride particles.

  Day 4, Day 11

• Change of nasal secretion weight during challenge over 4 hours with either HDM allergen with lactose particles compared to challenges with HDM allergen with sodium chloride particles

  Day 4, Day 11

Study Arms (5)

Sodium chloride particles

EXPERIMENTAL

Patients are exposed to sodium chloride particles alone for 4 hours in the Fraunhofer Allergen Challenge Chamber.

Other: Sodium chloride particles

Lactose particles

EXPERIMENTAL

Patients are exposed to lactose particles alone for 4 hours in the Fraunhofer Allergen Challenge Chamber.

Other: Lactose particles

Clean air

PLACEBO COMPARATOR

Patients are exposed to clean air for 4 hours in the Fraunhofer Allergen Challenge Chamber.

Other: Clean air

Sodium chloride particles with house dust mite

EXPERIMENTAL

Patients are exposed to sodium chloride particles coupled with D. pteronyssinus for 4 hours in the Fraunhofer Allergen Challenge Chamber.

Other: Sodium chloride particles with house dust mite

Lactose particles with house dust mite

EXPERIMENTAL

Patients are exposed to lactose particles coupled with D. pteronyssinus for 4 hours in the Fraunhofer Allergen Challenge Chamber.

Other: Lactose particles with house dust mite

Interventions

Sodium chloride particles OTHER

Patients are exposed to sodium chloride particles alone for 4 hours in the Fraunhofer Allergen Challenge Chamber.

Sodium chloride particles

Lactose particles OTHER

Patients are exposed to lactose particles alone for 4 hours in the Fraunhofer Allergen Challenge Chamber.

Lactose particles

Clean air OTHER

Patients are exposed to clean air for 4 hours in the Fraunhofer Allergen Challenge Chamber.

Clean air

Sodium chloride particles with house dust mite OTHER

Patients are exposed to sodium chloride particles coupled with D. pteronyssinus for 4 hours in the Fraunhofer Allergen Challenge Chamber.

Sodium chloride particles with house dust mite

Lactose particles with house dust mite OTHER

Patients are exposed to lactose particles coupled with D. pteronyssinus for 4 hours in the Fraunhofer Allergen Challenge Chamber.

Lactose particles with house dust mite

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to give written informed consent.
• Not pregnant, as confirmed by pregnancy test (see flow chart), and not nursing.
• Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meets clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit).
• Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first allergen challenge until at least 72 hours after the last allergen challenge -, implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
• 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.
• Smokers or non-smokers.

You may not qualify if:

• 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.
• Diastolic blood pressure above 95 mmHg.
• 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.
• Known or suspected clinically relevant intolerance to lactose .
• Asthma other than mild asthma which is treated with short acting beta-2-agonists only and which is controlled according to the current GINA guidelines.
• Participation in another clinical trial 30 days prior to enrollment.
• Donation of more than 400 ml of blood the preceding 2 months before screening.
• History of regular drug or alcohol abuse in the past 3 months.
• Risk of non-compliance with study procedures.
• Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.

Sponsors & Collaborators

• Fraunhofer-Institute of Toxicology and Experimental Medicine: lead

Study Sites (1)

Fraunhofer Institute for Toxicology and Experimental Medicine

Hanover, Lower Saxony, 30625, Germany

Location

Related Publications (1)

• Lueer K, Biller H, Casper A, Windt H, Mueller M, Badorrek P, Haefner D, Framke T, Koch A, Ziehr H, Krug N, Koch W, Hohlfeld JM. Safety, efficacy and repeatability of a novel house dust mite allergen challenge technique in the Fraunhofer allergen challenge chamber. Allergy. 2016 Dec;71(12):1693-1700. doi: 10.1111/all.12947. Epub 2016 Jun 23.

  PMID: 27255590 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Environment, Controlled; Antigens, Dermatophagoides

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Environment; Environment and Public Health; Antigens; Biological Factors

Study Officials

• Jens M Hohlfeld, Prof. Dr.

  Fraunhofer Institute for Toxicology and Experimental Medicine ITEM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are blinded to the sequence of exposures. Within the 2 blocks, the order of challenge atmospheres will be randomized.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Director of Airway Research

Model Details: 18 patients will be exposed 5 times in the Allergen Challenge Chamber. The 5 exposures are divided into 2 blocks. The first block consists of 3 challenges with sodium chloride particles, lactose particles, and clean air to address the primary and secondary objectives. The second block consists of 2 further challenges with D. pteronyssinus coupled with either sodium chloride particles or lactose particles to address exploratory objectives.

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 17, 2022
• Study Start: February 22, 2022
• Primary Completion: April 13, 2022
• Study Completion: April 13, 2022
• Last Updated: October 15, 2024

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)