Phenotyping Responses to Systemic Corticosteroids in the Management of Asthma Attacks

Summary

This observational study compares the phenotypic variability (clinical and biological) in treatment response to systemic corticosteroids according to the blood eosinophil count and FeNO in physician-diagnosed ≥12-year-old asthmatics presenting with an asthma attack and healthy controls.

Multimodal clinical and translational assessments will be performed on 50 physician-diagnosed, ≥12-year-old asthma patients presenting with an asthma attack and 12 healthy controls. These will include a blood eosinophil count, FeNO, and testing for airway infection (conventional sputum cultures and POC nasopharyngeal swabs). People with asthma will be assessed on day 0 and after a 7-day corticosteroid course, with in-home monitoring performed in between.

Conditions

• Asthma

Interventions

OTHER

Visit 1: Clinical exam and questionnaires

Medical history and examination, including vital signs, inhaler technique and adherence check (using prescript refills via the Dossier Santé Québec and/or calls to the community pharmacy), 5-item Asthma Control Questionnaire (ACQ-5), dyspnea rated on the modified Medical Research Council scale (mMRC), visual analog scale (VAS) for six respiratory symptoms, Pittsburgh Vocal Cord Dysfunction Index, Nijmegen Questionnaire, Hospital Anxiety and Depression Scale.

OTHER

Visit 1: Respiratory physiology

FeNO measurement (NIOX VERO device), pre/post-bronchodilator oscillometry (Tremoflo), and spirometry (including forced expiratory volume in 1 second (FEV1) reversibility, FEV1/FVC, peak expiratory flow).

OTHER

Visit 1: Inflammometry

Nasosorption with nasal epithelial lining fluid (NELF), nasal swab for ultrarapid SARS-CoV2 molecular test (ID NOW), nasopharyngeal swab for rapid multiplex PCR viral (BIOFIRE), nasal cytology brushes, blood tests (complete blood count with differential, C-reactive protein, total and specific serum immunoglobulin E, biobank), capillary blood eosinophils (Sight OLO), urine sample (creatinine, biobank), chest x-ray

OTHER

Visit 2: Clinical exam and questionnaires

Medical history and examination, including vital signs, symptom scores (ACQ-5, mMRC), visual analog scale (VAS) for six respiratory symptoms, Hospital Anxiety and Depression Scale, satisfaction questionnaire about point-of-care biomarker measurements, satisfaction questionnaire about point-of-care biomarker measurements: letter and email sent to treating doctor.

OTHER

Visit 2: Respiratory physiology

FeNO measurement (NIOX VERO device), pre/post-bronchodilator oscillometry (Tremoflo), and spirometry (including forced expiratory volume in 1 second (FEV1) reversibility, FEV1/FVC, peak expiratory flow).

OTHER

Visit 2: Inflammometry

SARS-CoV2 Test (ID NOW), nasosorption, nasal cytology brushes, blood tests (complete blood count with differential, C-reactive protein, biobank), capillary blood eosinophils (Sight OLO), urine sample (creatinine, biobank)

OTHER

Visit 3: e-mail

ACQ-5, peak flow measurement, and questions about the patient's asthma management.

Sponsors & Collaborators

• Sanofi-Regeneron

  collaborator UNKNOWN

• Réseau de Recherche en Santé Respiratoire du Québec

  collaborator UNKNOWN

• Association Pulmonaire du Quebec

  collaborator OTHER

• BioMérieux

  collaborator INDUSTRY

• Fonds de la Recherche en Santé du Québec

  collaborator OTHER_GOV

• Université de Sherbrooke

  lead OTHER

Principal Investigators

• Simon Couillard, MD, MSc. · Université de Sherbrooke

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-01

Primary Completion

2024-04-18

Completion

2024-06-13

Countries

• Canada

Study Locations