Effectiveness of an Air Purifier on Asthmatic and Cat-allergic Subjects in the ALYATEC Environmental Exposure Chamber

NCT06691568 | Completed

• 1 other identifier: 664E-BP06-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the efficacy of air purifiers in reducing allergy symptoms in patients with a cat allergy. The main question it aims to answer is: If there is a reduction of early asthmatic response (EAR) compared to placebo. Participants were asked to remain in an exposure chamber for 2 hours while their symptoms were monitored.

Conditions

Cat Allergy

Keywords

Cat allergy; EAR; Asthma; Purifier

Outcome Measures

Primary Outcomes (1)

• To measure the efficacy of air purifier on reducing the frequency of early asthmatic response (EAR) during a 2-hour cat allergen exposure in ALYATEC EEC compared to placebo.

  Comparing the number of subjects with a drop in FEV1≥ 20% within the 2-hour exposure

  Within the 2 hour exposure period

Secondary Outcomes (2)

• To evaluate the efficacy of air purifier on time to induce EAR during a 2-hour cat allergen exposure in ALYATEC EEC compared to placebo

  Within the 2 hour exposure period

• To evaluate the efficacy of air purifier on allergic rhino-conjunctivitis symptoms during a 2-hour cat allergen exposure in ALYATEC EEC compared to a placebo

  Within the 2 hour exposure period

Other Outcomes (3)

• To evaluate the efficacy of air purifier on bronchial response severity during a 2-hour cat allergen exposure in ALYATEC EEC compared to placebo

  Within the 2 hour exposure period

• To evaluate the rescue treatments used after 2-hour cat allergen exposure with the air purifier compared to placebo

  Within the 2 hour exposure period

• To evaluate the efficacy of air purifier on allergic rhinitis symptoms during a 2-hour cat allergen exposure in ALYATEC EEC compared to a placebo

  Within the 2 hour exposure period

Study Arms (2)

Active

ACTIVE COMPARATOR

Purifiers were active during cat allergen exposure

Device: Air purifier

Placebo

PLACEBO COMPARATOR

Purifiers were inactive during cat allergen exposure

Device: Air purifier

Interventions

Air purifier DEVICE

Purifiers were turned on for the active group and off for the placebo

Active; Placebo

Eligibility Criteria

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

You may qualify if:

• Subjects who signed the written informed consent
• Men or women aged between 18- and 65-year-old
• Subjects covered by health social identification number
• Subjects able to understand and complete study-related procedures
• Subjects reported history of symptomatic cat allergen-triggered asthma (GINA1-2) with or without associated allergic rhinitis and/or conjunctivitis
• Positive skin prick test (SPT) with cat hair extract with mean wheal diameter ≥ 5 mm compared to negative control (NaCl reaction \< 2 mm)
• Subjects with FEV1≥70% predicted at screening and before allergen exposure,
• Subjects with at least one drop in FEV1 ≥ 20% within the 2- hours exposure at baseline (V2)
• Women of childbearing potential with a negative pregnancy test throughout the study period and highly effective contraception: oral contraceptives, condom with spermicide, intrauterine device, bilateral tubal ligation, vasectomized partner.

You may not qualify if:

• Allergen immunotherapy to cat allergen for more than 1 month in the 3 years prior to the screening visit
• Ongoing allergen immunotherapy to another allergen
• History of anaphylactic reactions to cat allergen exposure or cat allergen immunotherapy
• Nasal polyposis, deviation of nasal septum, or diagnosis of uncontrolled non- allergic rhinitis
• Subjects allergic to indoor environmental allergens (molds, house dust mite allergens) with obvious exposure to these allergens causing allergic symptoms
• No cat exposure at home for the past year and must continue having no exposure at home during the study; cat exposure outside of the home shall be avoided for at least one week prior to any Cat Allergen Challenge
• Subjects with pollen season allergies (birch, grass, ash) will not be able to participate in the study during the pollen season for these allergens
• Conjunctival diseases such as severe keratitis, or other ocular disorders, ocular pain and/or photophobia during pollen season
• Moderate to severe asthma GINA 3 to 5

Sponsors & Collaborators

• Dyson Technology Ltd: lead
• Alyatec: collaborator

Study Sites (1)

ALYATEC - Nouvel Hôpital Civil

Strasbourg, France

Location

MeSH Terms

Conditions

Asthma

Interventions

Air Filters

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: January 20, 2023
• Primary Completion: October 26, 2023
• Study Completion: October 26, 2023
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

FR (1)