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Active, Not Recruiting

NCT Number: NCT07058259

Acupuncture for Persistent Dyspnea Despite Medical Treatment in COPD

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

COPD (Chronic Obstructive Pulmonary Disease) Acupuncture Chronic Disease Disease Attributes Dyspnea Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medeniyet University Faculty of Medicine

Istanbul, 34732, Turkey (Türkiye)

About this study

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.

Primary 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Volunteers aged between 40 and 80 years, who are communicative and cooperative,
  • Diagnosed with COPD for at least 3 months,
  • Receiving dual or triple regular pharmacological therapy for at least 3 months,
  • Post-bronchodilator FEV1/FVC <70% and predicted FEV1 <80% on spirometry, mMRC (Modified Medical Research Council) dyspnea score of 2 or higher,
  • COPD Assessment Test (CAT) score of 10 or higher.

Exclusion criteria

  • Patients who do not consent to participate in the study,
  • Patients with communication difficulties or with visual, walking, or hearing impairments,
  • Patients currently experiencing a COPD exacerbation or with a history of exacerbation within the past month,
  • Patients with Stage 1 COPD (FEV1 ≥ 80%),
  • COPD patients receiving monotherapy,
  • Patients with mMRC score <2 and CAT score <10,
  • 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,
  • Patients receiving long-term oxygen therapy (LTOT),
  • COPD patients who have experienced more than two exacerbations in the past year.

Withdrawal Criteria:

  • Patients who are unable to complete acupuncture sessions or follow-up assessments in the control group for any reason,
  • Patients who experience an exacerbation during the study (they will be reassessed one month after recovery and may be re-included if eligible),
  • Patients who miss more than two acupuncture sessions.

Treatment and study plan

Acupuncture

Behavioral

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.

Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS)

Drug

Patients in this group receive standard pharmacological treatment for COPD according to current clinical guidelines. Treatment includes either dual or triple inhaler therapy:

Dual 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.

Triple Therapy (LABA + LAMA + ICS): Patients receive the above combination of LABA and LAMA plus an inhaled corticosteroid (ICS) such as Budesonide, Fluticasone, or Beclometasone.

These 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.

Other names: Dual therapy (LAMA+LABA), Triple Therapy (LAMA+LABA+ICS)

Primary outcomes

  1. Modified Medical Research Council (mMRC) Dyspnea Scale

    Time frame: From baseline to the end of treatment at 6 weeks

    Change in dyspnea severity measured by the Modified Medical Research Council (mMRC) Dyspnea Scale from baseline to 6 weeks.

Secondary outcomes

  1. COPD Assessment Test (CAT)

    Time frame: From baseline to the end of treatment at 6 weeks

    Change in COPD Assessment Test (CAT) score.The CAT score evaluates overall symptom burden and quality of life in COPD patients.

  2. Change in Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: From baseline to the end of treatment at 6 weeks

    FEV1 will be measured via spirometry pre- and post-bronchodilator to assess lung function

  3. 6-Minute Walk Test (6MWT)

    Time frame: From baseline to the end of treatment at 6 weeks

    Change in exercise capacity measured by the 6-Minute Walk Test (6MWT) distance

  4. Incremental Shuttle Walk Test (ISWT)

    Time frame: From baseline to the end of treatment at 6 weeks

    Change in exercise tolerance assessed by the Incremental Shuttle Walk Test (ISWT)

  5. Change in Forced Vital Capacity (FVC)

    Time frame: From baseline to the end of treatment at 6 weeks

    FVC will be measured via spirometry pre- and post-bronchodilator to assess pulmonary capacity.

  6. Change in FEV1/FVC Ratio

    Time frame: From baseline to the end of treatment at 6 weeks

    The FEV1/FVC ratio will be calculated from spirometry values to evaluate airway obstruction severity.

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

The Effect of Acupuncture in COPD Patients With Persistent Dyspnea Despite Medical Treatment

Acronym: COPD

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 10, 2025
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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