Bronchodilator Response in COPD and Asthma: Correlation Between Spirometry, IOS Indices, and Dyspnea Relief

NCT07364188 | Not Yet Recruiting

• 1 other identifier: F-25059703
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 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. 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. 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.

Conditions

Bronchodilation; Asthma Bronchiale; COPD; Spirometry; Impedance; Small Airways Disease

Keywords

asthma; COPD; Correlation; Bronchodilator response; MCID

Outcome Measures

Primary Outcomes (3)

• FEV1

  Forced expiratory volumen in one second, L and % predicted

  Before and 20 minuttes after inhaled Salbutamol 0.4 mg

• X5

  Reactance at 5 Hz; kPa/L/s

  Before and 20 minuttes after inhaled Salbutamol 0.4 mg

• Dyspnoea

  Visual analog scale (0-100); 0 means no dyspnoea, and 100 means maximum dyspnoea

  Before and 20 minuttes after inhaled Salbutamol 0.4 mg

Secondary Outcomes (8)

• R5

  Before and 20 minuttes after inhaled Salbutamol 0.4 mg

• R5-R20

  Before and 20 minuttes after inhaled Salbutamol 0.4 mg

• Fres

  Before and 20 minuttes after inhaled Salbutamol 0.4 mg

• AX

  Before and 20 minuttes after inhaled Salbutamol 0.4 mg

• Delta-X5

  Before and 20 minuttes after inhaled Salbutamol 0.4 mg

Study Arms (2)

Asthma

FEV1/Forced Vital Capacity (FVC) \<0.7 at baseline (7) Visual Analog Scale (VAS) dyspnea score ≥10 (0-100, 100 max) (25,26). Doctor diagnosed asthma Less than 10 packyears. Exclusion Criteria: * Patients aged less than 18 years old. * Not able to perform spirometry or impulse oscillometry. * Cognitive disorders and not able to answer Asthma Control Questionnaire (ACQ), VAS dyspnea score, and COPD Assessment Test (CAT) score (25-28). * Short-acting beta-agonists 6 h, long-acting beta-agonists 2 days, short-acting anti-muscarinic agent 12 h, Long-acting anti-muscarinic agents 2 days. * Comorbidities with significant influence on dyspnea eg. bronchiectasis, ILS, mb. Cordis, lung resection, anemia, and active malignant disease * BMI ≥40 kg/m2.

Diagnostic Test: Bronchodilator

COPD

FEV1/Forced Vital Capacity (FVC) \<0.7 at baseline (7) Visual Analog Scale (VAS) dyspnea score ≥10 (0-100, 100 max) (25,26). Doctor diagnosed COPD Smokers or ex-smokers with ≥10 packyears Exclusion Criteria: * Patients aged less than 18 years old. * Not able to perform spirometry or impulse oscillometry. * Cognitive disorders and not able to answer Asthma Control Questionnaire (ACQ), VAS dyspnea score, and COPD Assessment Test (CAT) score (25-28). * Short-acting beta-agonists 6 h, long-acting beta-agonists 2 days, short-acting anti-muscarinic agent 12 h, Long-acting anti-muscarinic agents 2 days. * Comorbidities with significant influence on dyspnea eg. bronchiectasis, ILS, mb. Cordis, lung resection, anemia, and active malignant disease * BMI ≥40 kg/m2.

Diagnostic Test: Bronchodilator

Interventions

Bronchodilator DIAGNOSTIC_TEST

Classic beta-2-reversibility test

Asthma; COPD

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

referred to Allergy and Lung Clinic Elsinore, Denmark for evaluation of Asthma and COPD (obstructive lung disease)

You may qualify if:

• Both asthma and COPD patients:
• Written informed consent.
• FEV1/Forced Vital Capacity (FVC) \<0.7 at baseline (7)
• Visual Analog Scale (VAS) dyspnea score ≥10 (0-100, 100 max) (25,26).
• Asthma: Doctor diagnosed asthma
• \. less than 10 packyears.
• COPD: Doctor diagnosed COPD with FEV1/FVC \<0.7 post-bronchodilation 1. Smokers or ex-smokers with ≥10 packyears

You may not qualify if:

• Patients aged less than 18 years old.
• Not able to perform spirometry or impulse oscillometry.
• Cognitive disorders and not able to answer Asthma Control Questionnaire (ACQ), VAS dyspnea score, and COPD Assessment Test (CAT) score (25-28).
• Short-acting beta-agonists 6 h, long-acting beta-agonists 2 days, short-acting anti-muscarinic agent 12 h, Long-acting anti-muscarinic agents 2 days.
• Comorbidities with significant influence on dyspnea eg. bronchiectasis, ILS, mb. Cordis, lung resection, anemia, and active malignant disease
• BMI ≥40 kg/m2.

Sponsors & Collaborators

• Allergi- og Lungeklinikken, Elsinore: lead

Related Publications (15)

• Halpin DMG. Bronchodilator Responsiveness in Asthma and Chronic Obstructive Pulmonary Disease: Time to Stop Chasing Shadows. Am J Respir Crit Care Med. 2024 Feb 15;209(4):349-351. doi: 10.1164/rccm.202312-2248ED. No abstract available.

  PMID: 38190497 BACKGROUND

• Sim YS, Lee JH, Lee WY, Suh DI, Oh YM, Yoon JS, Lee JH, Cho JH, Kwon CS, Chang JH. Spirometry and Bronchodilator Test. Tuberc Respir Dis (Seoul). 2017 Apr;80(2):105-112. doi: 10.4046/trd.2017.80.2.105. Epub 2017 Mar 31.

  PMID: 28416951 BACKGROUND

• Dean J, Kolsum U, Hitchen P, Gupta V, Singh D. Clinical characteristics of COPD patients with tidal expiratory flow limitation. Int J Chron Obstruct Pulmon Dis. 2017 May 22;12:1503-1506. doi: 10.2147/COPD.S137865. eCollection 2017.

  PMID: 28579768 BACKGROUND

• Paredi P, Goldman M, Alamen A, Ausin P, Usmani OS, Pride NB, Barnes PJ. Comparison of inspiratory and expiratory resistance and reactance in patients with asthma and chronic obstructive pulmonary disease. Thorax. 2010 Mar;65(3):263-7. doi: 10.1136/thx.2009.120790.

  PMID: 20335298 BACKGROUND

• Bloom DA, Kaplan DJ, Mojica E, Strauss EJ, Gonzalez-Lomas G, Campbell KA, Alaia MJ, Jazrawi LM. The Minimal Clinically Important Difference: A Review of Clinical Significance. Am J Sports Med. 2023 Feb;51(2):520-524. doi: 10.1177/03635465211053869. Epub 2021 Dec 2.

  PMID: 34854345 BACKGROUND

• Saadeh C, Saadeh C, Cross B, Gaylor M, Griffith M. Advantage of impulse oscillometry over spirometry to diagnose chronic obstructive pulmonary disease and monitor pulmonary responses to bronchodilators: An observational study. SAGE Open Med. 2015 Apr 6;3:2050312115578957. doi: 10.1177/2050312115578957. eCollection 2015.

  PMID: 26770777 BACKGROUND

• Cottee AM, Seccombe LM, Thamrin C, King GG, Peters MJ, Farah CS. Bronchodilator Response Assessed by the Forced Oscillation Technique Identifies Poor Asthma Control With Greater Sensitivity Than Spirometry. Chest. 2020 Jun;157(6):1435-1441. doi: 10.1016/j.chest.2019.12.035. Epub 2020 Jan 23.

  PMID: 31982392 BACKGROUND

• Greig R, Stewart K, Chan R, Lipworth B. Assessment of bronchodilator responsiveness using low-frequency impedance in type 2-high uncontrolled severe asthma. Ann Allergy Asthma Immunol. 2025 Feb;134(2):231-232. doi: 10.1016/j.anai.2024.10.011. Epub 2024 Oct 9. No abstract available.

  PMID: 39383941 BACKGROUND

• Kaminsky DA, Simpson SJ, Berger KI, Calverley P, de Melo PL, Dandurand R, Dellaca RL, Farah CS, Farre R, Hall GL, Ioan I, Irvin CG, Kaczka DW, King GG, Kurosawa H, Lombardi E, Maksym GN, Marchal F, Oostveen E, Oppenheimer BW, Robinson PD, van den Berge M, Thamrin C. Clinical significance and applications of oscillometry. Eur Respir Rev. 2022 Feb 9;31(163):210208. doi: 10.1183/16000617.0208-2021. Print 2022 Mar 31.

  PMID: 35140105 BACKGROUND

• King GG, Bates J, Berger KI, Calverley P, de Melo PL, Dellaca RL, Farre R, Hall GL, Ioan I, Irvin CG, Kaczka DW, Kaminsky DA, Kurosawa H, Lombardi E, Maksym GN, Marchal F, Oppenheimer BW, Simpson SJ, Thamrin C, van den Berge M, Oostveen E. Technical standards for respiratory oscillometry. Eur Respir J. 2020 Feb 27;55(2):1900753. doi: 10.1183/13993003.00753-2019. Print 2020 Feb.

  PMID: 31772002 BACKGROUND

• Tashkin DP, Celli B, Senn S, Burkhart D, Kesten S, Menjoge S, Decramer M; UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008 Oct 9;359(15):1543-54. doi: 10.1056/NEJMoa0805800. Epub 2008 Oct 5.

  PMID: 18836213 BACKGROUND

• Janson C, Malinovschi A, Amaral AFS, Accordini S, Bousquet J, Buist AS, Canonica GW, Dahlen B, Garcia-Aymerich J, Gnatiuc L, Kowalski ML, Patel J, Tan W, Toren K, Zuberbier T, Burney P, Jarvis D. Bronchodilator reversibility in asthma and COPD: findings from three large population studies. Eur Respir J. 2019 Sep 5;54(3):1900561. doi: 10.1183/13993003.00561-2019. Print 2019 Sep.

  PMID: 31221806 BACKGROUND

• Kaminsky DA. What Is a Significant Bronchodilator Response? Ann Am Thorac Soc. 2019 Dec;16(12):1495-1497. doi: 10.1513/AnnalsATS.201908-604ED. No abstract available.

  PMID: 31774318 BACKGROUND

• Beasley R, Hughes R, Agusti A, Calverley P, Chipps B, Del Olmo R, Papi A, Price D, Reddel H, Mullerova H, Rapsomaniki E. Prevalence, Diagnostic Utility and Associated Characteristics of Bronchodilator Responsiveness. Am J Respir Crit Care Med. 2024 Feb 15;209(4):390-401. doi: 10.1164/rccm.202308-1436OC.

  PMID: 38029294 BACKGROUND

• Chan R, Lipworth BJ. Oscillometry bronchodilator response in adult moderate to severe eosinophilic asthma patients: A prospective cohort study. Clin Exp Allergy. 2022 Sep;52(9):1118-1120. doi: 10.1111/cea.14185. Epub 2022 Jun 22. No abstract available.

  PMID: 35707948 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Thomas J Ringbæk, MSci

  Allergi og Lungeklinikken Helsingør

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas J Ringbæk, MSci

CONTACT

+4521969087; thomasringbaek@gmail.com

Lars Frølund, MSci

CONTACT

+4521777696; lars.froelund@dadlnet.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 23, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share