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Completed

NCT Number: NCT03928561

Efficacy of Air Cleaners in Asthmatics Allergic to Cat in ALYATEC Environmental Exposure Chamber

The aim of this study is to determine the efficacy of Rowenta® "Intense Pure Air XL" air cleaner on the early and late bronchial response, in cat-allergic asthmatic patients during an allergen exposure in ALYATEC environmental chamber (EEC)

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alyatec

Strasbourg, Bas-Rhin, 67000, France

About this study

A monocentric, double-blind, placebo-controlled, cross-over study conducted outside of the pollen season. The study lasts 3 months for each patient, which includes a screening period, two exposure visits in the Alyatec Environmental Exposure Chamber (EEC) with active or placebo air cleaners, and a follow-up visit.

Patients with early asthmatic reaction during baseline exposure are randomly allocated to one of two sequences: active air cleaners /placebo or placebo/active air cleaners. Randomization is balanced (1:1) between the two sequences. There is a 3-week wash-out period between the two exposures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Controlled intermittent asthma (step 1 treatment, according to GINA Guideline 2016) with or without association with cat allergy related rhino-conjunctivitis;
  • Sensitization to cat allergen extract as defined by skin prick test for cat extract with a wheal diameter of ≥3 mm greater than negative control (ALK, HØrsholm, Denmark) and specific IgE anti Fel d 1 ≥ 0.7 kU/L ( ImmunoCAP, Thermofisher, Uppsala, Sweden);
  • FEV1 ≥ 70% of the predicted value;
  • No cat exposure at home or outside of the home during the study;
  • Positive methacholine challenge test performed using an AeroDoseur DTF-Atomisor ATO-AD 12 (Saint-Etienne, France);
  • Early asthmatic response during baseline cat allergen exposure.

Exclusion criteria

  • Uncontrolled asthma, asthma control test inferior to 20 within the 4 weeks preceding the study.
  • Uncontrolled asthma 2 weeks after stopping LABA treatment.
  • LABA treatment within the 2 weeks preceding the study.
  • Severe asthma (> GINA 2)
  • Subject lives with a cat
  • Cat desensibilisation within the 6 previous months.
  • Active smoker

Treatment and study plan

Active intense Pure Air XL air cleaner

Device

Cat allergen is nebulized in the EEC. When the concentration is stable, air cleaners are switched on. The number of air cleaners placed in the EEC is defined according to the volume of the EEC and the air renewal. Patients are exposed to cat allergen in the presence of active air cleaners in the EEC

Placebo Intense Pure Air XL air cleaner

Device

Cat allergen is nebulized in the EEC. When the concentration is stable, placebo air cleaners are switched on. The placebo effect is obtained thanks to the removal of air cleaners filters prior to the exposure. The number of placebo air cleaners placed in the EEC is defined according to the volume of the EEC and the air renewal. Patients are exposed to cat allergen in the presence of placebo air cleaners in the EEC.

Primary outcomes

  1. Frequency of early asthmatic response

    Time frame: Week 9

    In subjects exposed in the EEC to an average cat allergen concentration of 40 ng/m3 (Feld1) in presence of an active air cleaner compared to a placebo.

    Early asthmatic response is defined by a drop of at least 20% compared to baseline FEV1.

Secondary outcomes

  1. Frequency of late asthmatic response

    Time frame: Week 9

    Late asthmatic response is defined by a 15% drop of FEV1 compared to baseline FEV1 between 1h and 6h after the end of the allergen exposure.

  2. Severity of early and/or late asthmatic response

    Time frame: Week 9

    Evaluated by the maximum percentage of drop in FEV1. It was measured in subjects exposed to cat allergen with active air cleaners compared to placebo air cleaners.

  3. Difference of asthma symptoms during exposure to cat allergen with active air cleaners versus placebo.

    Time frame: Week 9

    The intensity of asthma symptoms is assessed using the visual analogue scale (VAS). The VAS is based on one question which allows to evaluate the symptoms on a scale from 0 to 10. 0 means no symptoms (best condition) and 10 means high symptoms (worse condition).

  4. Difference of rhinitis symptoms during exposure to cat allergen with active air cleaners versus placebo.

    Time frame: Week 9

    The intensity of rhinitis symptoms is assessed using the TNSS (Total Nasal Symptom Score) nasal self-assessment questionnaire. The score of the TNSS varies from 0 (no symptoms) to 12 (high symptoms).

  5. Difference of rhinitis symptoms during exposure to cat allergen with active air cleaners versus placebo.

    Time frame: Week 9

    The intensity of rhinitis symptoms is assessed using the visual analogue scale (VAS). The VAS is based on one question which allows to evaluate the symptoms on a scale from 0 to 10. 0 means no symptoms (best condition) and 10 means high symptoms (worse condition). A difference of 23 mm between two assessments done before and after exposure is considered as clinically significant.

  6. Difference of conjunctivitis symptoms during exposure to cat allergen with active air cleaners versus placebo.

    Time frame: Week 9

    The intensity of conjunctivitis symptoms is assessed using the TOSS (Total Ocular Symptom Score) conjunctival self-assessment questionnaire. It varies between 0 (no symptoms) and 6 (high symptoms).

  7. Difference of conjunctivitis symptoms during exposure to cat allergen with active air cleaners versus placebo.

    Time frame: Week 9

    The intensity of conjunctivitis symptoms is assessed using the visual analogue scale (conjunctivitis VAS). The VAS is based on one question which allows to evaluate the symptoms on a scale from 0 (no symptoms) to 10 (high symptoms).

  8. Difference of conjunctivitis symptoms during exposure to cat allergen with active air cleaners versus placebo.

    Time frame: Week 9

    The intensity of conjunctivitis symptoms is assessed using Abelson's Score. Abelson's score varies from 0 (no symptoms) to 13 (higher symptoms). A positive conjunctival response is defined by Albelson's Score evaluated by physician above or equal to 5 during allergen exposure.

Sponsors and collaborators

Lead sponsor

Alyatec

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 26, 2019
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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