Chronic Obstructive Pulmonary Disease (COPD)NCT07396311
Fractional Exhaled Nitric Oxide and Exacerbations of COPD
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a heterogeneous condition with recurrent exacerbations despite guideline-based therapy. This prospective observational cohort study aims to evaluate whether baseline fractional exhaled nitric oxide (FeNO), a biomarker of type 2 airway inflammation, predicts future… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2026to 29 Feb 2028
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants are recruited from adult COPD patients receiving routine pulmonary care at a tertiary hospital outpatient clinic, including follow-up visits after exacerbations and referrals from primary or emergency care.
Who may be able to join
- Adults aged 40 years or older
- Diagnosis of chronic obstructive pulmonary disease (COPD) confirmed by post-bronchodilator spirometry (FEV₁/FVC < 0.70).
- History of cigarette smoking
- Receiving triple inhaler therapy (inhaled corticosteroid/long-acting beta-agonist/long-acting muscarinic antagonist) as part of routine clinical care, including:
- patients who have been previously escalated to triple inhaler therapy due to prior exacerbations and are already receiving triple therapy at the time of enrollment, and
- patients who are newly prescribed triple inhaler therapy at or immediately before enrollment because of a recent exacerbation.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Chang Gung Medical Foundation
Taoyuan, 333
Ting-Yu Lin, MD., 886-3-3281200 ext. 8468, h12519@cgmh.org.tw
About this study
Official title: Fractional Exhaled Nitric Oxide (FeNO) as a Predictor of Exacerbations in COPD Patients Initiated on Triple Inhaler Therapy: A Prospective Exploratory Cohort Study
Chronic obstructive pulmonary disease (COPD) is a heterogeneous condition with recurrent exacerbations despite guideline-based therapy. This prospective observational cohort study aims to evaluate whether baseline fractional exhaled nitric oxide (FeNO), a biomarker of type 2 airway inflammation, predicts future exacerbations and lung function decline in COPD patients initiated on triple inhaler therapy in routine clinical practice. The study will also explore the relationships between air pollution exposure, type 2 inflammatory biomarkers, and COPD outcomes.
Read the detailed description
This is a pragmatic, prospective, longitudinal observational cohort study conducted in patients with COPD who are initiated on triple inhaler therapy as part of routine clinical care. No investigational drugs, devices, or protocol-mandated interventions are administered. Biomarker measurements, including fractional exhaled nitric oxide (FeNO), are performed for research purposes only and do not influence clinical decision-making.
Participants will be followed for up to 12 months after enrollment with scheduled assessments of exacerbation events, lung function, symptom burden, and biomarkers. The total study duration is approximately 24 months, accounting for a 12-month enrollment period and completion of follow-up for the last enrolled participant. Environmental air pollution exposure will be estimated using a validated hybrid kriging/land-use regression model based on residential address.
- Being tested
- No intervention assigned
- Keywords
- COPD, FeNO, Triple Inhaler Therapy, Exacerbation, Air Pollution, Type 2 Inflammation
- 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.
No intervention assignedOther
No investigational intervention is assigned in this observational study. All treatments, including triple inhaler therapy, are prescribed at the discretion of the treating physicians as part of routine clinical care. The research team does not assign, modify, or mandate any therapeutic intervention.
| Study group | Role | What they receive |
|---|---|---|
| COPD Patients Initiated on Triple Inhaler Therapy | This cohort includes patients with chronic obstructive pulmonary disease (COPD) receiving triple inhaler therapy (inhaled corticosteroid/long-acting beta-agonist/long-acting muscarinic antagonist) as part of routine clinical care following one or more recent exacerbations. Eligible participants include both patients who have been escalated to triple therapy due to prior exacerbations and are already receiving triple therapy at enrollment, as well as patients who are newly prescribed triple therapy at or immediately before enrollment because of a recent exacerbation. All participants are followed prospectively for up to 12 months to assess exacerbations, lung function, symptoms, and inflammatory biomarkers. Baseline fractional exhaled nitric oxide (FeNO) is evaluated as a predictor of clinical outcomes. Receives: Other: No intervention assigned |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized rate of moderate-to-severe COPD exacerbations
Moderate exacerbations are defined as those requiring systemic corticosteroids, antibiotics, or both. Severe exacerbations are defined as those requiring hospitalization or emergency department visits lasting more than 24 hours.
Measured: Up to 12 months after enrollment
Secondary outcomes (2)
Change in lung function (FEV₁)
Rate of decline in pre-bronchodilator FEV₁
Measured: Up to 12 months after enrollment
Change in COPD Assessment Test (CAT) score
Change in symptom burden assessed by CAT
Measured: Up to 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ting-Yu Lin, MD., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396311
- Sponsor's protocol ID
- 2512090251
- Status last verified
- Jan 2026
- First submitted
- 1 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The study involves clinical and environmental data that may pose a risk of re-identification despite de-identification, and no data-sharing infrastructure is currently established.
Publications
Papi A, Romagnoli M, Baraldo S, Braccioni F, Guzzinati I, Saetta M, Ciaccia A, Fabbri LM. Partial reversibility of airflow limitation and increased exhaled NO and sputum eosinophilia in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2000 Nov;162(5):1773-7. doi: 10.1164/ajrccm.162.5.9910112.
PubMed 11069811Alcazar-Navarrete B, Ruiz Rodriguez O, Conde Baena P, Romero Palacios PJ, Agusti A. Persistently elevated exhaled nitric oxide fraction is associated with increased risk of exacerbation in COPD. Eur Respir J. 2018 Jan 18;51(1):1701457. doi: 10.1183/13993003.01457-2017. Print 2018 Jan.
PubMed 29348180Zhou A, Zhou Z, Deng D, Zhao Y, Duan J, Cheng W, Liu C, Chen P. The Value of FENO Measurement for Predicting Treatment Response in Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2020 Sep 24;15:2257-2266. doi: 10.2147/COPD.S263673. eCollection 2020.
PubMed 33061343Romero-Linares A, Alvarez-Muro L, Hammadi A, Hoyas-Sanchez C, Jimenez-Anton A, Almansa-Lopez A, Casares-Martin-Moreno L, Sanchez-Alvarez E, Murillo-Rodriguez A, Gomez-Mora M, Gomez-Pontes Cabrera T, Romero-Palacios PJ, Alcazar-Navarrete B. Short term exacerbation risk and exhaled nitric oxide in COPD. Respir Med. 2025 Jul;243:108134. doi: 10.1016/j.rmed.2025.108134. Epub 2025 Apr 30.
PubMed 40316031
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional Exhaled Nitric Oxide (FeNO) as a Predictor of Exacerbations in COPD Patients Initiated on Triple Inhaler Therapy: A Prospective Exploratory Cohort Study
- ClinicalTrials.gov ID
- NCT07396311
- Acronym / sponsor ID
- 2512090251
- Keywords
- COPD, FeNO, Triple Inhaler Therapy, Exacerbation, Air Pollution, Type 2 Inflammation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 9 Feb 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.
Chronic obstructive pulmonary disease (COPD) is a heterogeneous condition with recurrent exacerbations despite guideline-based therapy. This prospective observational cohort study aims to evaluate whether baseline fractional exhaled nitric oxide (FeNO), a biomarker of type 2 airway inflammation, predicts future exacerbations and lung function decline in COPD patients initiated on triple inhaler therapy in routine clinical practice. The study will also explore the relationships between air pollution exposure, type 2 inflammatory biomarkers, and COPD outcomes.
Detailed description
This is a pragmatic, prospective, longitudinal observational cohort study conducted in patients with COPD who are initiated on triple inhaler therapy as part of routine clinical care. No investigational drugs, devices, or protocol-mandated interventions are administered. Biomarker measurements, including fractional exhaled nitric oxide (FeNO), are performed for research purposes only and do not influence clinical decision-making.
Participants will be followed for up to 12 months after enrollment with scheduled assessments of exacerbation events, lung function, symptom burden, and biomarkers. The total study duration is approximately 24 months, accounting for a 12-month enrollment period and completion of follow-up for the last enrolled participant. Environmental air pollution exposure will be estimated using a validated hybrid kriging/land-use regression model based on residential address.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD Patients Initiated on Triple Inhaler Therapy | – | Other: No intervention assignedThis cohort includes patients with chronic obstructive pulmonary disease (COPD) receiving triple inhaler therapy (inhaled corticosteroid/long-acting beta-agonist/long-acting muscarinic antagonist) as part of routine clinical care following one or more recent exacerbations. Eligible participants include both patients who have been escalated to triple therapy due to prior exacerbations and are already receiving triple therapy at enrollment, as well as patients who are newly prescribed triple therapy at or immediately before enrollment because of a recent exacerbation. All participants are followed prospectively for up to 12 months to assess exacerbations, lung function, symptoms, and inflammatory biomarkers. Baseline fractional exhaled nitric oxide (FeNO) is evaluated as a predictor of clinical outcomes. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants are recruited from adult COPD patients receiving routine pulmonary care at a tertiary hospital outpatient clinic, including follow-up visits after exacerbations and referrals from primary or emergency care.
Key inclusion criteria (6 listed)
- Adults aged 40 years or older
- Diagnosis of chronic obstructive pulmonary disease (COPD) confirmed by post-bronchodilator spirometry (FEV₁/FVC < 0.70).
- History of cigarette smoking
- Receiving triple inhaler therapy (inhaled corticosteroid/long-acting beta-agonist/long-acting muscarinic antagonist) as part of routine clinical care, including:
- patients who have been previously escalated to triple inhaler therapy due to prior exacerbations and are already receiving triple therapy at the time of enrollment, and
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| No intervention assignedNo investigational intervention is assigned in this observational study. All treatments, including triple inhaler therapy, are prescribed at the discretion of the treating physicians as part of routine clinical care. The research team does not assign, modify, or mandate any therapeutic intervention. | Other | COPD Patients Initiated on Triple Inhaler Therapy |
Primary outcome
Annualized rate of moderate-to-severe COPD exacerbations
Time frame: Up to 12 months after enrollment
Moderate exacerbations are defined as those requiring systemic corticosteroids, antibiotics, or both. Severe exacerbations are defined as those requiring hospitalization or emergency department visits lasting more than 24 hours.
2 secondary outcomes
Change in lung function (FEV₁)
Time frame: Up to 12 months after enrollment
Change in COPD Assessment Test (CAT) score
Time frame: Up to 12 months after enrollment
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 9 Feb 2026.
- Background: PubMed 11069811Papi A, Romagnoli M, Baraldo S, Braccioni F, Guzzinati I, Saetta M, Ciaccia A, Fabbri LM. Partial reversibility of airflow limitation and increased exhaled NO and sputum eosinophilia in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2000 Nov;162(5):1773-7. doi: 10.1164/ajrccm.162.5.9910112.
- Background: PubMed 29348180Alcazar-Navarrete B, Ruiz Rodriguez O, Conde Baena P, Romero Palacios PJ, Agusti A. Persistently elevated exhaled nitric oxide fraction is associated with increased risk of exacerbation in COPD. Eur Respir J. 2018 Jan 18;51(1):1701457. doi: 10.1183/13993003.01457-2017. Print 2018 Jan.
- Background: PubMed 33061343Zhou A, Zhou Z, Deng D, Zhao Y, Duan J, Cheng W, Liu C, Chen P. The Value of FENO Measurement for Predicting Treatment Response in Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2020 Sep 24;15:2257-2266. doi: 10.2147/COPD.S263673. eCollection 2020.
- Background: PubMed 40316031Romero-Linares A, Alvarez-Muro L, Hammadi A, Hoyas-Sanchez C, Jimenez-Anton A, Almansa-Lopez A, Casares-Martin-Moreno L, Sanchez-Alvarez E, Murillo-Rodriguez A, Gomez-Mora M, Gomez-Pontes Cabrera T, Romero-Palacios PJ, Alcazar-Navarrete B. Short term exacerbation risk and exhaled nitric oxide in COPD. Respir Med. 2025 Jul;243:108134. doi: 10.1016/j.rmed.2025.108134. Epub 2025 Apr 30.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The study involves clinical and environmental data that may pose a risk of re-identification despite de-identification, and no data-sharing infrastructure is currently established.
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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.
Ting-Yu Lin, MD. principal investigator
Chang Gung Memorial Hospital
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 Chronic Obstructive Pulmonary Disease (COPD), run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 6 inclusion and 1 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 9 Feb 2026. 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 Taiwan. 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?
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 Ting-Yu Lin, MD (+886-3-3281200 ext. 8468, h12519@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized rate of moderate-to-severe COPD exacerbations (time frame: Up to 12 months after enrollment). 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 NCT07396311, which also lists 4 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 9 Feb 2026.