Methacholine Challenge Testing: Comparison of FEV1 and IOS Parameters in Adult Asthma Patients

NCT06034145 | Unknown DMC

• 1 other identifier: Lungeklinikken_Elsinore
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

A classic methacholine challenge test is considered positive when forced expiratory volumen after one second (FEV1) decrease 20%. Impulse oscillometry (IOS) measures airway resistance and reactance, and seems more sensitive to changes in small airways. In adult asthma patients, we compare methacholine challenge test using both FEV1 and IOS.

Conditions

Bronchial Hyperreactivity

Keywords

asthma; oscillometry; spirometry; bronchial hyperreactivity

Outcome Measures

Primary Outcomes (7)

• ACQ-6

  Asthma Control Questionnaire (ACQ6) will be used in the 6 sub-score version omitting FEV1 % of predicted

  At entry (Cross sectional)

• Impulse Oscillometry

  Resistance at 5Hz (R5), R5-R20, reactance at 5Hz (X5), frequency response (Fres), areal under reactance curve (AX)

  At entry

• Demographic data

  General demographic data, including age, sex (male/female), body mass index (BMI) (kg/m2), and smoking history will be recorded.

  At entry

• Biomarker

  Serum eosinophils and hemoglobin will be measured

  At entry

• FeNO

  Measurement of Exhaled Nitric Oxide by NOBreath

  At entry

• Lung function and body box

  Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and the percentage of FEV1 in the estimated value will be measured at baseline and after methacholine test by Vyntus, Vyaire Medical. Body plethysmography with residual volumen (RV), total lung capacity (TLC), diffusion capacity of the lungs for carbon monoxide (DLCO), will be measured before methacholine test by Medical Electronic Construction (MEC).

  At entry

• Asthma medication

  Inhaled corticosteroids (ICS), long-acting beta2agonists (LABA), long-acting muscarinic antagonists (LAMA), Leukotriene antagonist, theophylline, and prednisolone - type and dose

  At entry

Study Arms (1)

Asthma

Asthma according to Gina Guidelines

Other: No intervention

Interventions

No intervention OTHER

No intervention

Asthma

Eligibility Criteria

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

Study Population

This is a cross-sectional analysis of a single-centered, observational study on adult (≥18 years old) patients referred with known asthma or asthma-like symptoms to a lung specialist clinic

You may qualify if:

• Doctor diagnosed asthma (based on symptoms and at least one positive asthma test within the last 5 years (AHR; reversibility to beta2-agonist, ICS, prednisolone; peak flow variation).
• Written informed consent.

You may not qualify if:

• patients aged less than 18 years old.
• patients with an exacerbation or lower airway infection within 1 months.
• Pulmonary function test: FEV1 (% pred.) \< 60%
• Not able to perform spirometry or body plethysmography.
• Cognitive disorders and not able to answer ACQ.
• Treated with biologics.
• Pregnancy or breastfeeding
• Short-acting beta-agonists 6 h, long-acting beta-agonists 2 days, short-acting anti-muscarinic agent 12 h, Long-acting anti-muscarinic agents 7 days, and Montelukast 3 days before methacholine challenge test (MCT).
• Comorbidity with significant influence on lung function and pulmonary symptoms eg. COPD, bronchiectasis, ischemic heart disease, heart failure, atrial fibrillation, uncontrolled hypertension (\>160/100 mmHg), lung cancer, lung resection, BMI\>40 kg/m2.

Sponsors & Collaborators

• Allergi- og Lungeklinikken, Elsinore: lead

MeSH Terms

Conditions

Bronchial Hyperreactivity; Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas Ringbæk, MSci

  Allergy and Lung Clinic Elsinore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Ringbæk, MSci

CONTACT

004521969087; thomasringbaek@gmail.com

Lars Frølund, MSci

CONTACT

004521777696; lars.froelund@dadlnet.dk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 14, 2023

Record last verified: 2023-09