COPD ExacerbationNCT07185581
Impulse Oscillometry in COPD Exacerbation
An observational study of COPD Exacerbation and COPD, run by Deniz Bilici at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate small airway function during ECOPD and recovery periods using IOS. In this prospective single-center study, patients with ECOPD underwent evaluation of their pulmonary functions using IOS and spirometry during exacerbation and recovery (6-12 weeks after exacerbation). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD Exacerbation, COPD
- What is being tested?
- Impulse Oscillometry
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 30 Sep 2024
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 41 patients who were consecutively admitted to the emergency department or pulmonology outpatient clinic of our hospital with a diagnosis of ECOPD, as defined by the GOLD 2023 Report 1 , were enrolled in the study.
Who may be able to join
- patients who were consecutively admitted to the emergency department or pulmonology outpatient clinic of our hospital with a diagnosis of ECOPD, as defined by the GOLD 2023 Report
Who cannot join
- Patients diagnosed with pneumonia, pulmonary embolism, heart failure, pleural effusion, or pneumothorax were excluded.
- Patients who were unable to perform spirometry during exacerbation or had a forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ratio of ≥ 0.70 were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Small Airway Function During COPD Exacerbation and Recovery Using Impulse Oscillometry (IOS) Device
This study aimed to evaluate small airway function during ECOPD and recovery periods using IOS. In this prospective single-center study, patients with ECOPD underwent evaluation of their pulmonary functions using IOS and spirometry during exacerbation and recovery (6-12 weeks after exacerbation). The patients were divided into two groups: mild exacerbations and (moderate and severe) exacerbations based on ROME criteria.A total of 41 patients were initially enrolled, with 38 completing the study. This study reveals that IOS can be easily used in ECOPD, and IOS parameters that reflect small airways (R5-R20, AX, and Fres) are correlated with FEV1% and the severity of dyspnea. Additionally, IOS parameters significantly improve during recovery, except for R20. Further research is necessary on its application in the functional assessment of patients with COPD exacerbations.
- Conditions
- COPD Exacerbation, COPD
- Being tested
- Impulse Oscillometry
- Keywords
- copd, exacerbation, ios, small airway
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impulse OscillometryDiagnostic test
Also called ios
Impulse Oscillometry (IOS) is a simple, non-invasive, effort-independent method that uses sound waves to detect airway changes quickly. It only requires the patient to breathe normally to assess lung function by measuring both resistance and reactance of the airways. 6,7 These features of IOS suggest it may be a useful test for assessing patient respiratory function during exacerbation periods when airway resistance, airflow limitation, and respiratory muscle weakness further impair breathing.
| Study group | Role | What they receive |
|---|---|---|
| mild exacerbations | Patients were divided into two groups: mild exacerbations (group 1) and moderate and severe exacerbations (group 2) based on ROME criteria. Receives: Diagnostic Test: Impulse Oscillometry | |
| moderate and severe exacerbations | Patients were divided into two groups: mild exacerbations (group 1) and moderate and severe exacerbations (group 2) based on ROME criteria. Receives: Diagnostic Test: Impulse Oscillometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological parameter of IOS in COPD exacerbation period
We investigated descriptive parameters of impulse oscillometry during copd exacerbation period to use in clinical setting in the future.
The parameters for assessing airway resistance, including resistance at 5 Hz (R5), which indicates total airway resistance; resistance at 20 Hz (R20), representing the resistance of large airways; and the difference between resistance at 5 Hz and 20 Hz ( R5-R20 ). The parameters that assess reactance are X5, which measures peripheral elastic resistance at 5 Hz; AX, the area under the reactance curve between 5 Hz and the resonant frequency, reflecting the elastic properties of the lung; and Fres, the oscillation frequency at which reactance is zero.
In the exacerbation of copd period FEV1% was correlated with all IOS parameters except R20, and BORG was correlated with IOS parameters except R20 and X5. Furthermore, IOS parameters reflecting the small airways (R5-R20, X5, AX, Fres) also showed strong intercorrelations.
Measured: from baseline
Secondary outcomes (2)
Comparison of parameter of IOS in COPD exacerbation period to stable period (approximately 6 weeks later)
Thirty-eight patients were re-evaluated during the recovery period. Significant improvements were observed in R5, R5-R20, AX, and Fres during recovery. No differences were observed in IOS parameters based on the severity of exacerbation.
Measured: 6 weeks later from the baseline
Comparison and correlations of IOS and pulmonary function test parameters in recovery period of COPD patient
We investigated correlation of IOS parameters such as R5, R5-R20, X5, AX, and Fres with pulmonary function test paramteres such as FEV1%, FVC%, FEV1/FVC We measured these parameters both in exacerbation and recovery periods of same patients and compared the results of two tests measurements
Measured: 6 weeks later from the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Mar 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Deniz Bilici
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Deniz Bilici, Istanbul Medeniyet University
- Investigators
- Esma Seda Akalın, MD, Principal investigator, Istanbul Medeniyet UniversityDeniz Koçak, Research Assistant, Principal investigator, Istanbul Medeniyet UniversityElif Hazal Karadağ, Research Assistant, Principal investigator, Istanbul Medeniyet UniversityBurcu Arpınar Yiğitbaş, Associate professor:, Principal investigator, Istanbul Medeniyet UniversityDeniz Bilici, MD, Principal investigator, Istanbul Medeniyet UniversityHandan Ankaralı, Professor, Principal investigator, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185581
- Sponsor's protocol ID
- 20.12.2023; 2023/0971
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All IPD used in the results publication
Publications
Anderson WJ, Lipworth BJ. Relationships between impulse oscillometry, spirometry and dyspnoea in COPD. J R Coll Physicians Edinb. 2012 Jun;42(2):111-5. doi: 10.4997/JRCPE.2012.204.
PubMed 22693693Haruna A, Oga T, Muro S, Ohara T, Sato S, Marumo S, Kinose D, Terada K, Nishioka M, Ogawa E, Hoshino Y, Hirai T, Chin K, Mishima M. Relationship between peripheral airway function and patient-reported outcomes in COPD: a cross-sectional study. BMC Pulm Med. 2010 Mar 7;10:10. doi: 10.1186/1471-2466-10-10.
PubMed 20205936Huang Y, Zhang X, Wang J, Bao W, Lv C, Zhang Y, Tian X, Zhou Y, Zhang M. Role of impulse oscillometry in chronic obstructive pulmonary disease and asthma-chronic obstructive pulmonary disease overlap. Clin Transl Allergy. 2025 Apr;15(4):e70057. doi: 10.1002/clt2.70057.
PubMed 40261129Gao L, Wang H, Wu Y, Wang T, Xiong S, Qiu R, Zhou H, Liu L, Jia H, Qin J, Xu D, Shen Y, Chen L, Wen FQ. Diagnostic value of impulse oscillometry in chronic obstructive pulmonary disease: a multicentre, retrospective, observational study. BMJ Open. 2024 Oct 8;14(10):e087687. doi: 10.1136/bmjopen-2024-087687.
PubMed 39384230Wei X, Shi Z, Cui Y, Mi J, Ma Z, Ren J, Li J, Xu S, Guo Y. Impulse oscillometry system as an alternative diagnostic method for chronic obstructive pulmonary disease. Medicine (Baltimore). 2017 Nov;96(46):e8543. doi: 10.1097/MD.0000000000008543.
PubMed 29145259Lu L, Peng J, Wu F, Yang H, Zheng Y, Deng Z, Zhao N, Dai C, Xiao S, Wen X, Xu J, Wu X, Zhou K, Ran P, Zhou Y. Clinical characteristics of airway impairment assessed by impulse oscillometry in patients with chronic obstructive pulmonary disease: findings from the ECOPD study in China. BMC Pulm Med. 2023 Feb 3;23(1):52. doi: 10.1186/s12890-023-02311-z.
PubMed 36737731Zheng S, Hu Y, Chen Z, Wang M, Liao W. Predicting asthma exacerbation by impulse oscillometry evaluation of small airway function and fractional exhaled nitric oxide in preschool children. Pediatr Pulmonol. 2020 Jul;55(7):1601-1607. doi: 10.1002/ppul.24790. Epub 2020 Apr 30.
PubMed 32353216Schulze J, Biedebach S, Christmann M, Herrmann E, Voss S, Zielen S. Impulse Oscillometry as a Predictor of Asthma Exacerbations in Young Children. Respiration. 2016;91(2):107-14. doi: 10.1159/000442448. Epub 2016 Jan 13.
PubMed 26756585Ling Y, Si M, Niu Y, Han Y, Xu Y. The predictive value of impulse oscillometry for asthma exacerbations in childhood: A systematic review and meta-analyses. Pediatr Pulmonol. 2021 Jul;56(7):1850-1856. doi: 10.1002/ppul.25374. Epub 2021 Mar 23.
PubMed 33756052Park H, Lee HJ, Lee HW, Park TY, Heo EY, Kim DK, Lee JK. Diagnosis and evaluation of small airway disease and COPD using impulse oscillometry. Sci Rep. 2024 Nov 14;14(1):28030. doi: 10.1038/s41598-024-79818-w.
PubMed 39543228Su ZQ, Guan WJ, Li SY, Ding M, Chen Y, Jiang M, Chen XB, Zhong CH, Tang CL, Zhong NS. Significances of spirometry and impulse oscillometry for detecting small airway disorders assessed with endobronchial optical coherence tomography in COPD. Int J Chron Obstruct Pulmon Dis. 2018 Oct 1;13:3031-3044. doi: 10.2147/COPD.S172639. eCollection 2018.
PubMed 30319251Duman D, Tasti OF, Merve Tepetam F. Assessment of small airway dysfunction by impulse oscillometry (IOS) in COPD and IPF patients. Eur Rev Med Pharmacol Sci. 2023 Apr;27(7):3033-3044. doi: 10.26355/eurrev_202304_31937.
PubMed 37070906Williamson PA, Clearie K, Menzies D, Vaidyanathan S, Lipworth BJ. Assessment of small-airways disease using alveolar nitric oxide and impulse oscillometry in asthma and COPD. Lung. 2011 Apr;189(2):121-9. doi: 10.1007/s00408-010-9275-y. Epub 2010 Dec 22.
PubMed 21174112Yanai M, Sekizawa K, Ohrui T, Sasaki H, Takishima T. Site of airway obstruction in pulmonary disease: direct measurement of intrabronchial pressure. J Appl Physiol (1985). 1992 Mar;72(3):1016-23. doi: 10.1152/jappl.1992.72.3.1016.
PubMed 1568955Hogg JC, Macklem PT, Thurlbeck WM. Site and nature of airway obstruction in chronic obstructive lung disease. N Engl J Med. 1968 Jun 20;278(25):1355-60. doi: 10.1056/NEJM196806202782501. No abstract available.
PubMed 5650164
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Small Airway Function During COPD Exacerbation and Recovery Using Impulse Oscillometry (IOS) Device
- ClinicalTrials.gov ID
- NCT07185581
- Acronym / sponsor ID
- 20.12.2023; 2023/0971
- Conditions
- COPD Exacerbation, COPD
- Keywords
- copd, exacerbation, ios, small airway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Deniz BiliciUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 22 Sep 2025 (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.
This study aimed to evaluate small airway function during ECOPD and recovery periods using IOS. In this prospective single-center study, patients with ECOPD underwent evaluation of their pulmonary functions using IOS and spirometry during exacerbation and recovery (6-12 weeks after exacerbation). The patients were divided into two groups: mild exacerbations and (moderate and severe) exacerbations based on ROME criteria.A total of 41 patients were initially enrolled, with 38 completing the study. This study reveals that IOS can be easily used in ECOPD, and IOS parameters that reflect small airways (R5-R20, AX, and Fres) are correlated with FEV1% and the severity of dyspnea. Additionally, IOS parameters significantly improve during recovery, except for R20. Further research is necessary on its application in the functional assessment of patients with COPD exacerbations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mild exacerbations | – | Diagnostic Test: Impulse OscillometryPatients were divided into two groups: mild exacerbations (group 1) and moderate and severe exacerbations (group 2) based on ROME criteria. |
| moderate and severe exacerbations | – | Diagnostic Test: Impulse OscillometryPatients were divided into two groups: mild exacerbations (group 1) and moderate and severe exacerbations (group 2) based on ROME criteria. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 41 patients who were consecutively admitted to the emergency department or pulmonology outpatient clinic of our hospital with a diagnosis of ECOPD, as defined by the GOLD 2023 Report 1 , were enrolled in the study.
Key inclusion criteria (1 listed)
- patients who were consecutively admitted to the emergency department or pulmonology outpatient clinic of our hospital with a diagnosis of ECOPD, as defined by the GOLD 2023 Report
Key exclusion criteria (2 listed)
- Patients diagnosed with pneumonia, pulmonary embolism, heart failure, pleural effusion, or pneumothorax were excluded.
- Patients who were unable to perform spirometry during exacerbation or had a forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ratio of ≥ 0.70 were also excluded.
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 |
|---|---|---|
| Impulse OscillometryAlso: iosImpulse Oscillometry (IOS) is a simple, non-invasive, effort-independent method that uses sound waves to detect airway changes quickly. It only requires the patient to breathe normally to assess lung function by measuring both resistance and reactance of the airways. 6,7 These features of IOS suggest it may be a useful test for assessing patient respiratory function during exacerbation periods when airway resistance, airflow limitation, and respiratory muscle weakness further impair breathing. | Diagnostic test | mild exacerbations, moderate and severe exacerbations |
Primary outcome
Physiological parameter of IOS in COPD exacerbation period
Time frame: from baseline
We investigated descriptive parameters of impulse oscillometry during copd exacerbation period to use in clinical setting in the future. The parameters for assessing airway resistance, including resistance at 5 Hz (R5), which indicates total airway resistance; resistance at 20 Hz (R20), representing the resistance of large airways; and the difference between resistance at 5 Hz and 20 Hz ( R5-R20 ). The parameters that assess reactance are X5, which measures peripheral elastic resistance at 5 Hz; AX, the area under the reactance curve between 5 Hz and the resonant frequency, reflecting the elastic properties of the lung; and Fres, the oscillation frequency at which reactance is zero. In the exacerbation of copd period FEV1% was correlated with all IOS parameters except R20, and BORG was correlated with IOS parameters except R20 and X5. Furthermore, IOS parameters reflecting the small airways (R5-R20, X5, AX, Fres) also showed strong intercorrelations.
2 secondary outcomes
Comparison of parameter of IOS in COPD exacerbation period to stable period (approximately 6 weeks later)
Time frame: 6 weeks later from the baseline
Comparison and correlations of IOS and pulmonary function test parameters in recovery period of COPD patient
Time frame: 6 weeks later from the baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Results publication: PubMed 22693693Anderson WJ, Lipworth BJ. Relationships between impulse oscillometry, spirometry and dyspnoea in COPD. J R Coll Physicians Edinb. 2012 Jun;42(2):111-5. doi: 10.4997/JRCPE.2012.204.
- Results publication: PubMed 20205936Haruna A, Oga T, Muro S, Ohara T, Sato S, Marumo S, Kinose D, Terada K, Nishioka M, Ogawa E, Hoshino Y, Hirai T, Chin K, Mishima M. Relationship between peripheral airway function and patient-reported outcomes in COPD: a cross-sectional study. BMC Pulm Med. 2010 Mar 7;10:10. doi: 10.1186/1471-2466-10-10.
- Results publication: PubMed 40261129Huang Y, Zhang X, Wang J, Bao W, Lv C, Zhang Y, Tian X, Zhou Y, Zhang M. Role of impulse oscillometry in chronic obstructive pulmonary disease and asthma-chronic obstructive pulmonary disease overlap. Clin Transl Allergy. 2025 Apr;15(4):e70057. doi: 10.1002/clt2.70057.
- Results publication: PubMed 39384230Gao L, Wang H, Wu Y, Wang T, Xiong S, Qiu R, Zhou H, Liu L, Jia H, Qin J, Xu D, Shen Y, Chen L, Wen FQ. Diagnostic value of impulse oscillometry in chronic obstructive pulmonary disease: a multicentre, retrospective, observational study. BMJ Open. 2024 Oct 8;14(10):e087687. doi: 10.1136/bmjopen-2024-087687.
- Results publication: PubMed 29145259Wei X, Shi Z, Cui Y, Mi J, Ma Z, Ren J, Li J, Xu S, Guo Y. Impulse oscillometry system as an alternative diagnostic method for chronic obstructive pulmonary disease. Medicine (Baltimore). 2017 Nov;96(46):e8543. doi: 10.1097/MD.0000000000008543.
- Results publication: PubMed 36737731Lu L, Peng J, Wu F, Yang H, Zheng Y, Deng Z, Zhao N, Dai C, Xiao S, Wen X, Xu J, Wu X, Zhou K, Ran P, Zhou Y. Clinical characteristics of airway impairment assessed by impulse oscillometry in patients with chronic obstructive pulmonary disease: findings from the ECOPD study in China. BMC Pulm Med. 2023 Feb 3;23(1):52. doi: 10.1186/s12890-023-02311-z.
- Results publication: PubMed 32353216Zheng S, Hu Y, Chen Z, Wang M, Liao W. Predicting asthma exacerbation by impulse oscillometry evaluation of small airway function and fractional exhaled nitric oxide in preschool children. Pediatr Pulmonol. 2020 Jul;55(7):1601-1607. doi: 10.1002/ppul.24790. Epub 2020 Apr 30.
- Results publication: PubMed 26756585Schulze J, Biedebach S, Christmann M, Herrmann E, Voss S, Zielen S. Impulse Oscillometry as a Predictor of Asthma Exacerbations in Young Children. Respiration. 2016;91(2):107-14. doi: 10.1159/000442448. Epub 2016 Jan 13.
- Results publication: PubMed 33756052Ling Y, Si M, Niu Y, Han Y, Xu Y. The predictive value of impulse oscillometry for asthma exacerbations in childhood: A systematic review and meta-analyses. Pediatr Pulmonol. 2021 Jul;56(7):1850-1856. doi: 10.1002/ppul.25374. Epub 2021 Mar 23.
- Results publication: PubMed 39543228Park H, Lee HJ, Lee HW, Park TY, Heo EY, Kim DK, Lee JK. Diagnosis and evaluation of small airway disease and COPD using impulse oscillometry. Sci Rep. 2024 Nov 14;14(1):28030. doi: 10.1038/s41598-024-79818-w.
- Results publication: PubMed 30319251Su ZQ, Guan WJ, Li SY, Ding M, Chen Y, Jiang M, Chen XB, Zhong CH, Tang CL, Zhong NS. Significances of spirometry and impulse oscillometry for detecting small airway disorders assessed with endobronchial optical coherence tomography in COPD. Int J Chron Obstruct Pulmon Dis. 2018 Oct 1;13:3031-3044. doi: 10.2147/COPD.S172639. eCollection 2018.
- Results publication: PubMed 37070906Duman D, Tasti OF, Merve Tepetam F. Assessment of small airway dysfunction by impulse oscillometry (IOS) in COPD and IPF patients. Eur Rev Med Pharmacol Sci. 2023 Apr;27(7):3033-3044. doi: 10.26355/eurrev_202304_31937.
- Individual participant dataSharing planned: Undecided. All IPD used in the results publication
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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. This study is not recruiting at the moment.
Esma Seda Akalın, MD principal investigator
Istanbul Medeniyet University
Deniz Koçak, Research Assistant principal investigator
Istanbul Medeniyet University
Elif Hazal Karadağ, Research Assistant principal investigator
Istanbul Medeniyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation and COPD, run by Deniz Bilici at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological parameter of IOS in COPD exacerbation period (time frame: from baseline). 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 NCT07185581, which also lists 32 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 22 Sep 2025.