Bronchodilator
Diagnostic TestClassic beta-2-reversibility test
NCT Number: NCT07364188
A bronchodilator reversibility test is widely used in the diagnosis and management of obstructive lung diseases.
Bronchodilators relieve symptoms in asthma and COPD. Traditionally, their effectiveness has been assessed using spirometric indices, particularly FEV₁. However, changes in FEV₁ often do not correlate well with patients' subjective experience of dyspnoea relief or with changes in small airway function.
Impulse oscillometry (IOS) provides an effort-independent assessment of respiratory mechanics during tidal breathing and is more sensitive to small airway dysfunction than spirometry. Despite this, the clinical utility of IOS in routine COPD and asthma assessment remains underexplored, and its relationship to both spirometric response and symptom relief is not fully established, and the Minimal Clinically Important Difference (MCID) for IOS parameters has not been firmly established. Determining the MCID is essential for interpreting individual patient responses in a clinically meaningful way and for guiding treatment decisions in both research and practice.
Hypothesis & Aims
In patients with either asthma or COPD baseline values and bronchodilator responses are compared. More specifically, this study aims to:
1. assess baseline correlations: Evaluate the correlation between ΔX5-baseline (EFL expiratory flow limitation=small airway collapse during expiration), RV/TLC-baseline, X5-average at baseline, FEV1-baseline, VAS-dyspnea at baseline, and ACQ-6-baseline. 2. compare bronchodilator responses across methods: Examine the correlation between bronchodilator-induced changes in FEV₁ and IOS parameters (including both average and delta values) and explore their relationship with short-term changes in dyspnea. 3. establish clinical relevance: Determine the MCID for key IOS variables using both anchor-based and distribution-based approaches, anchored to perceived changes in lung symptoms.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Introduction and aims: see brief summary.
Method and Patients This is a real-life, cross-sectional analysis of a single-centered, observational study on 60 adult patients with clinical diagnosed asthma and 60 COPD patients, consecutively recruited between February 1, 2026, and June 30, 2027, and followed at least 6 months for diagnostic clarification.
Inclusion criteria
Both asthma and COPD patients:
Asthma: Doctor diagnosed asthma 1. less than 10 packyears.
COPD: Doctor diagnosed COPD with FEV1/FVC <0.7 post-bronchodilation
Exclusion criteria
It is a real-life study where most patients are followed up within 6 months. The diagnosis - asthma, COPD, or other condition - may change after follow-up (maximum 6 months after the index examination).
Minimal Clinical Important Difference
Anchor-Based Methods:
Distribution-Based Methods:
Brochodilator test and order of test To avoid or minimize the effect of deep inhalation on IOS, IOS was performed at least 15 minutes after spirometry and body box.
Patients were administered 4 doses of 0.1 mg Ventoline (salbutamol) via pressurized metered-dose inhaler and spacer (Aero Champer). Post-IOS and post-spirometry were performed 15-20 minutes after the bronchodilator inhalation
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Classic beta-2-reversibility test
Time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Forced expiratory volumen in one second, L and % predicted
Time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Reactance at 5 Hz; kPa/L/s
Time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Visual analog scale (0-100); 0 means no dyspnoea, and 100 means maximum dyspnoea
Time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Resistance at 5 Hz, kPa/L/s and % predicted
Time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Resistance in small airways, kPa/L/s
Time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Resonant frequency (stiffness), Hz
Time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Area of reactance, kPa/L
Time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Inspiratory - expiratory difference in X5, kPa/L/s
Time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Inspiratory - expiratory difference in R5 (total resitance), kPa/L/s
Time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Expiratory Flow at 25% to 75% during spirometry, L and % predicted
Time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
FEV1/forced expiratory capacity (FVC)
Contact information is provided by the study sponsor or research team.
Lars Frølund, MSci
CONTACT
Thomas J Ringbæk, MSci
CONTACT
Allergi- og Lungeklinikken, Elsinore
Network
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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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