Phenotyping Responses to Systemic Corticosteroids in the Management of Asthma Attacks

NCT05870215 | Completed

• 1 other identifier: 00001
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Exacerbations; Biomarkers; Eosinophils; Nitric oxide; Corticosteroids; Phenotypes; Treatable traits; Precision medicine

Outcome Measures

Primary Outcomes (1)

• Change in FEV1.

  Difference in FEV1 (% change and Litre change) before and after prednisone

  Baseline and 7 days.

Secondary Outcomes (5)

• Change in Visual analogue scale (VAS) dyspnea rating

  Baseline and 7 days.

• Change in asthma control questionnaire (ACQ-5)

  Baseline and 7 days.

• Change in FVC

  Baseline and 7 days.

• Change in FEV1/FVC

  Baseline and 7 days.

• Change in oscillometry R5-R20

  Baseline and 7 days

Study Arms (2)

Exacerbation patients

Age ≥12 years old with physician-diagnosed asthma since \>6 months experiencing an asthma attack with a patient and/or physician decision to initiate a burst of systemic corticosteroids (but not yet started), assessed within 24 hours on weekdays after a screening telephone call.

Other: Visit 1: Clinical exam and questionnaires; Other: Visit 1: Respiratory physiology; Other: Visit 1: Inflammometry; Other: Visit 2: Clinical exam and questionnaires; Other: Visit 2: Respiratory physiology; Other: Visit 2: Inflammometry; Other: Visit 3: e-mail

Healty controls

Age ≥12 years, non-atopic, non-smoking, with normal spirometry and no history of lung disease.

Other: Visit 1: Clinical exam and questionnaires; Other: Visit 1: Respiratory physiology; Other: Visit 1: Inflammometry

Interventions

Visit 1: Clinical exam and questionnaires OTHER

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.

Exacerbation patients; Healty controls

Visit 1: Respiratory physiology OTHER

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).

Exacerbation patients; Healty controls

Visit 1: Inflammometry OTHER

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

Exacerbation patients; Healty controls

Visit 2: Clinical exam and questionnaires OTHER

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.

Exacerbation patients

Visit 2: Respiratory physiology OTHER

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).

Exacerbation patients

Visit 2: Inflammometry OTHER

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)

Exacerbation patients

Visit 3: e-mail OTHER

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

Exacerbation patients

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients ≥12 years old with physician-diagnosed asthma since \>6 months experiencing an asthma attack with a patient and/or physician decision to initiate a burst of systemic corticosteroids (but not yet started) assessed within 24 hours on weekdays after a screening telephone call.

You may qualify if:

• Patients ≥12 years old with physician-diagnosed asthma for \>6 months
• Experiencing an asthma attack with a patient and/or physician's decision to initiate a burst of systemic corticosteroids (but not yet started)
• Assessed within 24 hours on weekdays after a screening telephone call.
• For healthy volunteers: Non-atopic, non-smoking subjects with normal spirometry and no history of lung disease

You may not qualify if:

• Asthma treated with a monoclonal antibody or maintenance oral glucocorticosteroids
• Current smoking
• SARS-CoV-2-positive event
• Significant overlapping cardiopulmonary disease (including chronic obstructive pulmonary disease, defined as age \>40 years old AND persistent airflow limitation with FEV1/FVC\<0.7 AND \>10 pack-year smoking history (or alpha-1-antitrypsin deficiency))
• Confounding immunological state
• Pregnancy
• Contraindication to oral corticosteroids use

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Sanofi-Regeneron: collaborator
• Réseau de Recherche en Santé Respiratoire du Québec: collaborator
• Association Pulmonaire du Quebec: collaborator
• BioMérieux: collaborator
• Fonds de la Recherche en Santé du Québec: collaborator

Study Sites (1)

Centre de Recherche du CHUS

Sherbrooke, Quebec, J1H5N4, Canada

Location

Related Publications (38)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma, whole blood Nasopharingeal swabs Nasosorption for NELF (nasal epithelial lining fluid) Sputum (±induced) Urine sample

MeSH Terms

Conditions

Asthma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Simon Couillard, MD, MSc.

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Pulmonologist, Researcher

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 23, 2023
• Study Start: September 1, 2022
• Primary Completion: April 18, 2024
• Study Completion: June 13, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

CA (1)