Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:52 AM
Study NCT ID:
NCT07376161
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-02-25
First Post:
2026-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inflammation and Oxidative Stress in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Peripheral venous blood samples will be collected before and after the pulmonary rehabilitation program. Serum samples will be separated and stored for the analysis of inflammatory and oxidative stress biomarkers, including IL-6, TNF-α, IL-33, and NRF-2-related parameters. No DNA extraction or genetic testing will be performed.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}, 'targetDuration': '8 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-01-21', 'studyFirstSubmitQcDate': '2026-01-21', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Inflammatory and Oxidative Stress Biomarkers After Pulmonary Rehabilitation in COPD Patients', 'timeFrame': 'Baseline (before pulmonary rehabilitation) and after 8 weeks of pulmonary rehabilitation', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Association Between Changes in Inflammatory and Oxidative Stress Biomarkers and Clinical and Functional Outcomes After Pulmonary Rehabilitation', 'timeFrame': 'Baseline (before pulmonary rehabilitation) and after 8 weeks of pulmonary rehabilitation', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'Oxidative Stress', 'Inflamation', 'Pulmonary Rehabilitation'], 'conditions': ['Inflamation', 'COPD', 'Oxidative Stress', 'Pulmonary Rehabilitation']}, 'referencesModule': {'references': [{'pmid': '17671825', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '39631681', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '24127811', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '35731514', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '31479415', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '32709500', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '30322439', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '17376663', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '16040783', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '37818173', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '36225291', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '37517999', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '37371927', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '23994347', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '33946941', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '25378921', 'type': 'RESULT', 'citation': 'Domej W, Oettl K, Renner W. Oxidative stress and free radicals in COPD--implications and relevance for treatment. Int J Chron Obstruct Pulmon Dis. 2014 Oct 17;9:1207-24. doi: 10.2147/COPD.S51226. eCollection 2014.'}, {'pmid': '35624831', 'type': 'RESULT', 'citation': 'Barnes PJ. Oxidative Stress in Chronic Obstructive Pulmonary Disease. Antioxidants (Basel). 2022 May 13;11(5):965. doi: 10.3390/antiox11050965.'}, {'pmid': '30992736', 'type': 'RESULT', 'citation': 'Katerji M, Filippova M, Duerksen-Hughes P. Approaches and Methods to Measure Oxidative Stress in Clinical Samples: Research Applications in the Cancer Field. Oxid Med Cell Longev. 2019 Mar 12;2019:1279250. doi: 10.1155/2019/1279250. eCollection 2019.'}, {'pmid': '11359957', 'type': 'RESULT', 'citation': 'Noguera A, Batle S, Miralles C, Iglesias J, Busquets X, MacNee W, Agusti AG. Enhanced neutrophil response in chronic obstructive pulmonary disease. Thorax. 2001 Jun;56(6):432-7. doi: 10.1136/thorax.56.6.432.'}, {'pmid': '37286219', 'type': 'RESULT', 'citation': 'Troosters T, Janssens W, Demeyer H, Rabinovich RA. Pulmonary rehabilitation and physical interventions. Eur Respir Rev. 2023 Jun 7;32(168):220222. doi: 10.1183/16000617.0222-2022. Print 2023 Jun 30.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 40-80 years with a diagnosis of stable COPD\n* 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)\n* Former smokers with a smoking history of at least 10 pack-years\n* Clinically stable disease at the time of enrollment\n* Ability and willingness to participate in the pulmonary rehabilitation program\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Current smokers\n* History of acute COPD exacerbation or respiratory infection within the past 6 weeks\n* Presence of other chronic lung diseases (e.g., bronchiectasis, interstitial lung disease, asthma)\n* Active malignancy\n* Severe or uncontrolled cardiovascular disease, including recent acute myocardial infarction or malignant arrhythmias\n* Neurological, orthopedic, or psychiatric conditions that preclude objective functional assessment or participation in exercise training\n* Use of antioxidant or vitamin supplementation within the past 4 weeks\n* Determination by a cardiologist that participation in an exercise-based rehabilitation program is not medically appropriate'}, 'identificationModule': {'nctId': 'NCT07376161', 'briefTitle': 'Inflammation and Oxidative Stress in COPD', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medeniyet University'}, 'officialTitle': 'The Effect of Pulmonary Rehabilitation on Inflammation and Oxidative Stress in COPD', 'orgStudyIdInfo': {'id': '23.10.2025; 2025/0255'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pulmonary Rehabilitation', 'type': 'BEHAVIORAL', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34730', 'city': 'Istanbul', 'state': 'Kadikoy', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medeniyet University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'All IPD used in the results publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Esra Yazar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Pulmonary Medicine, Clinical Professor', 'investigatorFullName': 'Esra Yazar', 'investigatorAffiliation': 'Istanbul Medeniyet University'}}}}