Asthma BronchialeNCT07364188
Bronchodilator Response in COPD and Asthma: Correlation Between Spirometry, IOS Indices, and Dyspnea Relief
An observational study of Asthma Bronchiale and COPD, run by Allergi- og Lungeklinikken, Elsinore.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma Bronchiale, COPD, Bronchodilation
- What is being tested?
- Bronchodilator
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: referred to Allergy and Lung Clinic Elsinore, Denmark for evaluation of Asthma and COPD (obstructive lung disease)
Who may be able to join
- 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
- 1. less than 10 packyears.
- COPD: Doctor diagnosed COPD with FEV1/FVC <0.7 post-bronchodilation 1. Smokers or ex-smokers with ≥10 packyears
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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:
- 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.
- 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.
- 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.
Read the detailed description
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:
- Written informed consent.
- FEV1/Forced Vital Capacity (FVC) <0.7 at baseline )
- Visual Analog Scale (VAS) dyspnea score ≥10 (0-100, 100 max).
Asthma: Doctor diagnosed asthma 1. less than 10 packyears.
COPD: Doctor diagnosed COPD with FEV1/FVC <0.7 post-bronchodilation
- 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.
- 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.
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:
- The receiver operating characteristic (ROC) curve-based method determines the minimum clinically important difference (MCID) by identifying the value that maximizes the Youden Index. This index is calculated as the maximum sum of sensitivity and specificity. Using data from patients who rate themselves "a little better" and patients who rate themselves "no change"
- The social comparison approach provides the MCID as the mean of two differences: the difference of mean score between patients who rate themselves as "a little worse" and patients who rate themselves "no change".
- Within-patients score change MCID is the mean delta score of patients who rate themselves "a little better".
- The methods of 95% limits of upper agreement: MCID is the mean delta score -1.96 standard error of the delta score of the patients who answered "no change"
Distribution-Based Methods:
- MCID defined as standard error of measurement (SEM) evaluated on the baseline values from patients who rated themselves "no change".
- MCID defined as 0.5 SD of delta score from patients who answered "a little better"
- MCID is defined as 1.96 × √2 × SEM, assessed on baseline values from patients who reported "no change", which represents the smallest change in a measurement that can be considered a "real" change, rather than just random measurement error.
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
- Conditions
- Asthma Bronchiale, COPD, Bronchodilation, Spirometry, Impedance, Small Airways Disease
- Being tested
- Bronchodilator
- Keywords
- asthma, COPD, Correlation, Bronchodilator response, MCID
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchodilatorDiagnostic test
Classic beta-2-reversibility test
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Bronchodilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
Forced expiratory volumen in one second, L and % predicted
Measured: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
X5
Reactance at 5 Hz; kPa/L/s
Measured: 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
Measured: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Secondary outcomes (8)
R5
Resistance at 5 Hz, kPa/L/s and % predicted
Measured: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
R5-R20
Resistance in small airways, kPa/L/s
Measured: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Fres
Resonant frequency (stiffness), Hz
Measured: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
AX
Area of reactance, kPa/L
Measured: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Delta-X5
Inspiratory - expiratory difference in X5, kPa/L/s
Measured: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Delta R5
Inspiratory - expiratory difference in R5 (total resitance), kPa/L/s
Measured: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
FEF 25-75
Expiratory Flow at 25% to 75% during spirometry, L and % predicted
Measured: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
FEV1/FVC-ratio
FEV1/forced expiratory capacity (FVC)
Measured: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Asthma BronchialeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allergi- og Lungeklinikken, Elsinore
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Thomas J Ringbæk, MSci, Principal investigator, Allergi og Lungeklinikken Helsingør
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364188
- Sponsor's protocol ID
- F-25059703
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I have not applied for permission to share data with others.
Publications
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.
PubMed 38190497Sim 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.
PubMed 28416951Dean 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.
PubMed 28579768Paredi 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.
PubMed 20335298Bloom 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.
PubMed 34854345Saadeh 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.
PubMed 26770777Cottee 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.
PubMed 31982392Greig 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.
PubMed 39383941Kaminsky 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.
PubMed 35140105King 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.
PubMed 31772002Tashkin 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.
PubMed 18836213Janson 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.
PubMed 31221806Kaminsky 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.
PubMed 31774318Beasley 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.
PubMed 38029294Chan 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.
PubMed 35707948
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchodilator Response in COPD and Asthma: Correlation Between Spirometry, IOS Indices, and Dyspnea Relief
- ClinicalTrials.gov ID
- NCT07364188
- Acronym / sponsor ID
- F-25059703
- Conditions
- Asthma Bronchiale, COPD, Bronchodilation, Spirometry, Impedance, Small Airways Disease
- Keywords
- asthma, COPD, Correlation, Bronchodilator response, MCID
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Allergi- og Lungeklinikken, ElsinoreResearch network
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Detailed description
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:
- Written informed consent.
- FEV1/Forced Vital Capacity (FVC) <0.7 at baseline )
- Visual Analog Scale (VAS) dyspnea score ≥10 (0-100, 100 max).
Asthma: Doctor diagnosed asthma 1. less than 10 packyears.
COPD: Doctor diagnosed COPD with FEV1/FVC <0.7 post-bronchodilation
- 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.
- 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.
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:
- The receiver operating characteristic (ROC) curve-based method determines the minimum clinically important difference (MCID) by identifying the value that maximizes the Youden Index. This index is calculated as the maximum sum of sensitivity and specificity. Using data from patients who rate themselves "a little better" and patients who rate themselves "no change"
- The social comparison approach provides the MCID as the mean of two differences: the difference of mean score between patients who rate themselves as "a little worse" and patients who rate themselves "no change".
- Within-patients score change MCID is the mean delta score of patients who rate themselves "a little better".
- The methods of 95% limits of upper agreement: MCID is the mean delta score -1.96 standard error of the delta score of the patients who answered "no change"
Distribution-Based Methods:
- MCID defined as standard error of measurement (SEM) evaluated on the baseline values from patients who rated themselves "no change".
- MCID defined as 0.5 SD of delta score from patients who answered "a little better"
- MCID is defined as 1.96 × √2 × SEM, assessed on baseline values from patients who reported "no change", which represents the smallest change in a measurement that can be considered a "real" change, rather than just random measurement error.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | Diagnostic Test: BronchodilatorFEV1/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. |
| COPD | – | Diagnostic Test: BronchodilatorFEV1/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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- referred to Allergy and Lung Clinic Elsinore, Denmark for evaluation of Asthma and COPD (obstructive lung disease)
Key inclusion criteria (7 listed)
- 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 1. Smokers or ex-smokers with ≥10 packyears
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BronchodilatorClassic beta-2-reversibility test | Diagnostic test | Asthma, COPD |
Primary outcome
FEV1
Time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Forced expiratory volumen in one second, L and % predicted
X5
Time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Reactance at 5 Hz; kPa/L/s
Dyspnoea
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
8 secondary outcomes
R5
Time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
R5-R20
Time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Fres
Time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
AX
Time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Delta-X5
Time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Delta R5
Time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
FEF 25-75
Time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
FEV1/FVC-ratio
Time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Background: PubMed 38190497Halpin 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.
- Background: PubMed 28416951Sim 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.
- Background: PubMed 28579768Dean 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.
- Background: PubMed 20335298Paredi 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.
- Background: PubMed 34854345Bloom 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.
- Background: PubMed 26770777Saadeh 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.
- Background: PubMed 31982392Cottee 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.
- Background: PubMed 39383941Greig 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.
- Background: PubMed 35140105Kaminsky 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.
- Background: PubMed 31772002King 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.
- Background: PubMed 18836213Tashkin 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.
- Background: PubMed 31221806Janson 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.
- Individual participant dataSharing planned: No. I have not applied for permission to share data with others.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas J Ringbæk, MSci principal investigator
Allergi og Lungeklinikken Helsingør
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma Bronchiale and COPD, run by Allergi- og Lungeklinikken, Elsinore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas J Ringbæk, MSci (+4521969087, thomasringbaek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1 (time frame: Before and 20 minuttes after inhaled Salbutamol 0.4 mg). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07364188, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.