AzTrials
AzTrials

InflamationNCT07376161

Inflammation and Oxidative Stress in COPD

An observational study of Inflamation and COPD, run by Esra Yazar at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide, characterized by persistent airflow limitation, chronic inflammation, and increased oxidative stress. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Inflamation, COPD, Oxidative Stress
What is being tested?
Pulmonary Rehabilitation
How many people
27 participants
Where
1 siteTurkey (Türkiye)
Study dates
6 Jan 2026to 1 May 2026
How long will I take part?
8 Weeks
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients aged 40 to 80 years with a diagnosis of stable COPD, defined according to the GOLD criteria (FEV₁/FVC < 70% and FEV₁ < 70% predicted), who are former smokers with a smoking history of at least 10 pack-years, and who are referred to the pulmonary rehabilitation program of our institution, will be consecutively enrolled in the study.

Who may be able to join

  • Adults aged 40-80 years with a diagnosis of stable COPD
  • Airflow limitation defined according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria (forced expiratory volume in 1 second / forced vital capacity [FEV₁/FVC] < 70% and forced expiratory volume in 1 second [FEV₁] < 70% predicted)
  • Former smokers with a smoking history of at least 10 pack-years
  • Clinically stable disease at the time of enrollment
  • Ability and willingness to participate in the pulmonary rehabilitation program
  • Provision of written informed consent

Who cannot join

  • Current smokers
  • History of acute COPD exacerbation or respiratory infection within the past 6 weeks
  • Presence of other chronic lung diseases (e.g., bronchiectasis, interstitial lung disease, asthma)
  • Active malignancy
  • Severe or uncontrolled cardiovascular disease, including recent acute myocardial infarction or malignant arrhythmias
  • Neurological, orthopedic, or psychiatric conditions that preclude objective functional assessment or participation in exercise training
  • Use of antioxidant or vitamin supplementation within the past 4 weeks
  • Determination by a cardiologist that participation in an exercise-based rehabilitation program is not medically appropriate

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Istanbul Medeniyet University

    Istanbul, Kadikoy, 34730

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Pulmonary Rehabilitation on Inflammation and Oxidative Stress in COPD

Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide, characterized by persistent airflow limitation, chronic inflammation, and increased oxidative stress. Despite optimal pharmacological treatment, many patients continue to experience symptoms, reduced exercise capacity, and frequent exacerbations. Pulmonary rehabilitation (PR) is an evidence-based, non-pharmacological intervention that improves symptoms, functional capacity, quality of life, and survival in patients with COPD; however, its biological effects on inflammatory and oxidative stress pathways remain insufficiently defined.

This study aims to evaluate the effects of pulmonary rehabilitation on systemic inflammation and oxidative stress in patients with stable COPD. Serum levels of pro-inflammatory cytokines (interleukin-6 [IL-6], tumor necrosis factor alpha [TNF-α]) and the epithelial alarmin interleukin-33 (IL-33), which is released in response to airway epithelial injury, as well as nuclear factor erythroid 2-related factor 2 (NRF-2) gene and/or protein expression as a key regulator of antioxidant defense, will be measured before and after a standardized pulmonary rehabilitation program. By assessing changes in these biomarkers, this study seeks to determine whether pulmonary rehabilitation exerts disease-modifying effects beyond symptomatic improvement and functional outcomes.

The findings are expected to provide novel insights into the biological mechanisms of pulmonary rehabilitation and to support its role as a targeted, cost-effective intervention in the comprehensive management of COPD.

Being tested
Pulmonary Rehabilitation
Keywords
COPD, Oxidative Stress, Inflamation, Pulmonary Rehabilitation
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.

  • Pulmonary RehabilitationBehavioural

    Participants will undergo a standardized, supervised pulmonary rehabilitation program consisting of exercise training, breathing exercises, and patient education. The program will include aerobic exercise training (treadmill or cycle ergometer), strength training of upper and lower limb muscles, and respiratory muscle training, conducted under the supervision of a multidisciplinary rehabilitation team. Sessions will be performed multiple times per week over a predefined program duration. The intervention will be applied in addition to standard pharmacological treatment, with no changes to maintenance medications during the study period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Inflammatory and Oxidative Stress Biomarkers After Pulmonary Rehabilitation in COPD Patients

    The primary outcome measure is the change in serum levels of inflammatory and oxidative stress biomarkers following the pulmonary rehabilitation program in patients with stable COPD. Serum concentrations of IL-6, TNF-α, and IL-33, as well as NRF-2 gene and/or protein expression, will be measured before and after the intervention to evaluate the biological effects of pulmonary rehabilitation on systemic inflammation and oxidative stress.

    Measured: Baseline (before pulmonary rehabilitation) and after 8 weeks of pulmonary rehabilitation

Secondary outcomes (1)
  1. Association Between Changes in Inflammatory and Oxidative Stress Biomarkers and Clinical and Functional Outcomes After Pulmonary Rehabilitation

    The secondary outcome measure is the relationship between levels and changes in inflammatory and oxidative stress biomarkers and changes in clinical and functional parameters following pulmonary rehabilitation in patients with stable COPD. Changes in serum IL-6, TNF-α, IL-33, and NRF-2-related parameters will be correlated with post-rehabilitation changes in dyspnea severity, exercise capacity, and health-related quality of life measures.

    Measured: Baseline (before pulmonary rehabilitation) and after 8 weeks of pulmonary rehabilitation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2026
  2. Study start6 Jan 2026
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 May 2026 (estimated)

Resources

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
27 participants (estimated)
Target duration
8 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT07376161
Sponsor's protocol ID
23.10.2025; 2025/0255
Status last verified
Feb 2026
First submitted
21 Jan 2026
Last updated
25 Feb 2026
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

  • Joppa P, Petrasova D, Stancak B, Dorkova Z, Tkacova R. Oxidative stress in patients with COPD and pulmonary hypertension. Wien Klin Wochenschr. 2007;119(13-14):428-34. doi: 10.1007/s00508-007-0819-y.

    PubMed 17671825
  • Celli BR, Anzueto A, Singh D, Hanania NA, Fabbri L, Martinez FJ, Soler X, Djandji M, Jacob-Nara JA, Rowe PJ, Deniz Y, Radwan A. The Emerging Role of Alarmin-Targeting Biologics in the Treatment of Patients With COPD. Chest. 2025 May;167(5):1346-1355. doi: 10.1016/j.chest.2024.09.049. Epub 2024 Dec 2.

    PubMed 39631681
  • Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.

    PubMed 24127811
  • Mosher CL, Nanna MG, Jawitz OK, Raman V, Farrow NE, Aleem S, Casaburi R, MacIntyre NR, Palmer SM, Myers ER. Cost-effectiveness of Pulmonary Rehabilitation Among US Adults With Chronic Obstructive Pulmonary Disease. JAMA Netw Open. 2022 Jun 1;5(6):e2218189. doi: 10.1001/jamanetworkopen.2022.18189.

    PubMed 35731514
  • Pehlivan E, Yazar E, Balci A, Kilic L. Comparison of Compliance Rates and Treatment Efficiency in Home-Based with Hospital-Based Pulmonary Rehabilitation in COPD. Turk Thorac J. 2019 Jul 1;20(3):192-197. doi: 10.5152/TurkThoracJ.2019.18060. Print 2019 Jul.

    PubMed 31479415
  • Pehlivan E, Yazar E, Balci A, Turan D, Demirkol B, Cetinkaya E. A comparative study of the effectiveness of hospital-based versus home-based pulmonary rehabilitation in candidates for bronchoscopic lung volume reduction. Heart Lung. 2020 Nov-Dec;49(6):959-964. doi: 10.1016/j.hrtlng.2020.06.011. Epub 2020 Jul 21.

    PubMed 32709500
  • Ozmen I, Yildirim E, Ozturk M, Ocakli B, Yildiz R, Aydin R, Karakis M, Yilmaz O, Aksoy E. Pulmonary Rehabilitation Reduces Emergency Admission and Hospitalization Rates of Patients with Chronic Respiratory Diseases. Turk Thorac J. 2018 Sep 13;19(4):170-175. doi: 10.5152/TurkThoracJ.2018.17089. Print 2018 Oct.

    PubMed 30322439
  • Pinho RA, Chiesa D, Mezzomo KM, Andrades ME, Bonatto F, Gelain D, Dal Pizzol F, Knorst MM, Moreira JC. Oxidative stress in chronic obstructive pulmonary disease patients submitted to a rehabilitation program. Respir Med. 2007 Aug;101(8):1830-5. doi: 10.1016/j.rmed.2007.02.004. Epub 2007 Mar 26.

    PubMed 17376663
  • Mercken EM, Hageman GJ, Schols AM, Akkermans MA, Bast A, Wouters EF. Rehabilitation decreases exercise-induced oxidative stress in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 Oct 15;172(8):994-1001. doi: 10.1164/rccm.200411-1580OC. Epub 2005 Jul 22.

    PubMed 16040783
  • Beykumul A, Ersoy Y, Gulbas G, Neselioglu S. Can Blood Biomarkers Be Used to Assess Oxidative Stress in COPD Patients After Pulmonary Rehabilitation. Int J Chron Obstruct Pulmon Dis. 2023 Oct 5;18:2179-2186. doi: 10.2147/COPD.S400415. eCollection 2023.

    PubMed 37818173
  • Zhao X, Zhang Q, Zheng R. The interplay between oxidative stress and autophagy in chronic obstructive pulmonary disease. Front Physiol. 2022 Sep 26;13:1004275. doi: 10.3389/fphys.2022.1004275. eCollection 2022.

    PubMed 36225291
  • Cazzola M, Page CP, Wedzicha JA, Celli BR, Anzueto A, Matera MG. Use of thiols and implications for the use of inhaled corticosteroids in the presence of oxidative stress in COPD. Respir Res. 2023 Jul 31;24(1):194. doi: 10.1186/s12931-023-02500-8.

    PubMed 37517999
  • Miklos Z, Horvath I. The Role of Oxidative Stress and Antioxidants in Cardiovascular Comorbidities in COPD. Antioxidants (Basel). 2023 May 31;12(6):1196. doi: 10.3390/antiox12061196.

    PubMed 37371927
  • Stockley JA, Walton GM, Lord JM, Sapey E. Aberrant neutrophil functions in stable chronic obstructive pulmonary disease: the neutrophil as an immunotherapeutic target. Int Immunopharmacol. 2013 Dec;17(4):1211-7. doi: 10.1016/j.intimp.2013.05.035. Epub 2013 Aug 27.

    PubMed 23994347
  • Zinellu E, Zinellu A, Fois AG, Pau MC, Scano V, Piras B, Carru C, Pirina P. Oxidative Stress Biomarkers in Chronic Obstructive Pulmonary Disease Exacerbations: A Systematic Review. Antioxidants (Basel). 2021 Apr 29;10(5):710. doi: 10.3390/antiox10050710.

    PubMed 33946941

Questions about this trial

What is this clinical trial studying?

An observational study of Inflamation and COPD, run by Esra Yazar 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 6 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 25 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 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?

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?

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?

Change in Inflammatory and Oxidative Stress Biomarkers After Pulmonary Rehabilitation in COPD Patients (time frame: Baseline (before pulmonary rehabilitation) and after 8 weeks of pulmonary rehabilitation). 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 NCT07376161, which also lists 20 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 25 Feb 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in