Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-01-01 @ 5:03 PM
Study NCT ID:
NCT07058259
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-10
First Post:
2025-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture for Persistent Dyspnea Despite Medical Treatment in COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004417', 'term': 'Dyspnea'}], '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'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'C084098', 'term': 'laminin A'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2025-06-22', 'studyFirstSubmitQcDate': '2025-06-30', 'lastUpdatePostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modified Medical Research Council (mMRC) Dyspnea Scale', 'timeFrame': 'From baseline to the end of treatment at 6 weeks', 'description': 'Change in dyspnea severity measured by the Modified Medical Research Council (mMRC) Dyspnea Scale from baseline to 6 weeks.'}], 'secondaryOutcomes': [{'measure': 'COPD Assessment Test (CAT)', 'timeFrame': 'From baseline to the end of treatment at 6 weeks', 'description': 'Change in COPD Assessment Test (CAT) score.The CAT score evaluates overall symptom burden and quality of life in COPD patients.'}, {'measure': 'Change in Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'From baseline to the end of treatment at 6 weeks', 'description': 'FEV1 will be measured via spirometry pre- and post-bronchodilator to assess lung function'}, {'measure': '6-Minute Walk Test (6MWT)', 'timeFrame': 'From baseline to the end of treatment at 6 weeks', 'description': 'Change in exercise capacity measured by the 6-Minute Walk Test (6MWT) distance'}, {'measure': 'Incremental Shuttle Walk Test (ISWT)', 'timeFrame': 'From baseline to the end of treatment at 6 weeks', 'description': 'Change in exercise tolerance assessed by the Incremental Shuttle Walk Test (ISWT)'}, {'measure': 'Change in Forced Vital Capacity (FVC)', 'timeFrame': 'From baseline to the end of treatment at 6 weeks', 'description': 'FVC will be measured via spirometry pre- and post-bronchodilator to assess pulmonary capacity.'}, {'measure': 'Change in FEV1/FVC Ratio', 'timeFrame': 'From baseline to the end of treatment at 6 weeks', 'description': 'The FEV1/FVC ratio will be calculated from spirometry values to evaluate airway obstruction severity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'ACUPUNCTURE', 'dyspnea', 'chronic obstructive pulmonary disease'], 'conditions': ['COPD (Chronic Obstructive Pulmonary Disease)', 'Acupuncture']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aims to evaluate the effectiveness of acupuncture as an adjunctive non-pharmacological therapy in patients with stable COPD who continue to experience dyspnea despite optimal medical treatment.', 'detailedDescription': 'A total of 60 patients diagnosed with COPD will be randomly assigned to either a control group receiving standard pharmacological treatment or an intervention group receiving standard treatment plus acupuncture. The intervention group will undergo 10 acupuncture sessions (twice weekly for 5 weeks) using predefined acupuncture points based on previous COPD studies.\n\nPrimary outcomes include changes in dyspnea severity measured by the Modified Medical Research Council (mMRC) Dyspnea Scale, the COPD Assessment Test (CAT), and the Borg scale. Secondary outcomes include changes in pulmonary function (FEV1, FVC, FEV1/FVC) and functional exercise capacity assessed by the 6-Minute Walk Test (6MWT) and Incremental Shuttle Walk Test (ISWT). Spirometry and exercise testing will be performed pre- and post-intervention. The study will help determine whether acupuncture provides statistically and clinically meaningful improvements in symptom burden and exercise tolerance in COPD management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteers aged between 40 and 80 years, who are communicative and cooperative,\n* Diagnosed with COPD for at least 3 months,\n* Receiving dual or triple regular pharmacological therapy for at least 3 months,\n* Post-bronchodilator FEV1/FVC \\<70% and predicted FEV1 \\<80% on spirometry, mMRC (Modified Medical Research Council) dyspnea score of 2 or higher,\n* COPD Assessment Test (CAT) score of 10 or higher.\n\nExclusion Criteria:\n\n* Patients who do not consent to participate in the study,\n* Patients with communication difficulties or with visual, walking, or hearing impairments,\n* Patients currently experiencing a COPD exacerbation or with a history of exacerbation within the past month,\n* Patients with Stage 1 COPD (FEV1 ≥ 80%),\n* COPD patients receiving monotherapy,\n* Patients with mMRC score \\<2 and CAT score \\<10,\n* Patients with unstable angina, acute myocardial infarction (within 3-5 days), uncontrolled arrhythmia, active endocarditis, acute myocarditis/pericarditis, symptomatic severe aortic stenosis, lower extremity DVT, uncontrolled asthma/COPD, pulmonary edema, oxygen saturation (SpO₂) ≤ 90%, acute respiratory failure, or suspected dissecting aneurysm,\n* Patients receiving long-term oxygen therapy (LTOT),\n* COPD patients who have experienced more than two exacerbations in the past year.\n\nWithdrawal Criteria:\n\n* Patients who are unable to complete acupuncture sessions or follow-up assessments in the control group for any reason,\n* Patients who experience an exacerbation during the study (they will be reassessed one month after recovery and may be re-included if eligible),\n* Patients who miss more than two acupuncture sessions.'}, 'identificationModule': {'nctId': 'NCT07058259', 'acronym': 'COPD', 'briefTitle': 'Acupuncture for Persistent Dyspnea Despite Medical Treatment in COPD', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Medeniyet University'}, 'officialTitle': 'The Effect of Acupuncture in COPD Patients With Persistent Dyspnea Despite Medical Treatment', 'orgStudyIdInfo': {'id': 'MU Acupuncture and COPD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard COPD Pharmacological Treatment Group (Control)', 'description': 'Drug: Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS) Patients receive standard pharmacological treatment for COPD according to current clinical guidelines without acupuncture. This will serve as a control group.', 'interventionNames': ['Drug: Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS)']}, {'type': 'EXPERIMENTAL', 'label': 'Acupuncture + Standard COPD Pharmacological Treatment Group (Intervention)', 'description': 'Participants in this group will receive standard pharmacological treatment for COPD in addition to acupuncture therapy. - Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS)\n\nAcupuncture will be administered twice weekly for 5 weeks (10 sessions total) at predefined bilateral acupoints: LU1, LU9, LI18, ST36, GB12, BL13, BL20, and BL23. Single-use, sterile 25 mm × 0.25 mm needles will be inserted at each point for 20 minutes per session.', 'interventionNames': ['Behavioral: Acupuncture', 'Drug: Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS)']}], 'interventions': [{'name': 'Acupuncture', 'type': 'BEHAVIORAL', 'description': 'Acupuncture will be administered twice weekly for 5 weeks (10 sessions total) at predefined bilateral acupoints: LU1, LU9, LI18, ST36, GB12, BL13, BL20, and BL23. Single-use, sterile 25 mm × 0.25 mm needles will be inserted at each point for 20 minutes per session.', 'armGroupLabels': ['Acupuncture + Standard COPD Pharmacological Treatment Group (Intervention)']}, {'name': 'Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS)', 'type': 'DRUG', 'otherNames': ['Dual therapy (LAMA+LABA)', 'Triple Therapy (LAMA+LABA+ICS)'], 'description': 'Patients in this group receive standard pharmacological treatment for COPD according to current clinical guidelines. Treatment includes either dual or triple inhaler therapy:\n\nDual Therapy (LABA + LAMA): Patients receive a long-acting beta-agonist (LABA) such as Formoterol, Salmeterol, Olodaterol, Vilanterol, or Indacaterol, in combination with a long-acting muscarinic antagonist (LAMA) such as Tiotropium bromide, Umeclidinium, or Glycopyrronium.\n\nTriple Therapy (LABA + LAMA + ICS): Patients receive the above combination of LABA and LAMA plus an inhaled corticosteroid (ICS) such as Budesonide, Fluticasone, or Beclometasone.\n\nThese medications may be administered either as fixed-dose combination inhalers or as separate inhalers, depending on patient needs and physician discretion. The treatment regimen is individualized based on clinical condition, prior therapy, and symptom severity.', 'armGroupLabels': ['Acupuncture + Standard COPD Pharmacological Treatment Group (Intervention)', 'Standard COPD Pharmacological Treatment Group (Control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34732', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medeniyet University Faculty of Medicine', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Medeniyet University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Specialist of PMR,Principal Investigator', 'investigatorFullName': 'Bilinç Doğruöz Karatekin', 'investigatorAffiliation': 'Istanbul Medeniyet University'}}}}