COPD (Chronic Obstructive Pulmonary Disease)COPDNCT07058259
Acupuncture for Persistent Dyspnea Despite Medical Treatment in COPD
A study testing Acupuncture and Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS) in people with COPD (Chronic Obstructive Pulmonary Disease) and Acupuncture, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Acupuncture
- What is being tested?
- Acupuncture and Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 15 Jan 2026
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University Faculty of Medicine
Istanbul, 34732
About this study
Official title: The Effect of Acupuncture in COPD Patients With Persistent Dyspnea Despite Medical Treatment
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.
Read the detailed description
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.
- Being tested
- Acupuncture, Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS)
- Keywords
- COPD, ACUPUNCTURE, dyspnea, chronic obstructive pulmonary disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureBehavioural
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
Also called Dual therapy (LAMA+LABA), Triple Therapy (LAMA+LABA+ICS)
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard COPD Pharmacological Treatment Group (Control) | Active comparator | 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. Receives: Drug: Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS) |
| Acupuncture + Standard COPD Pharmacological Treatment Group (Intervention) | Experimental | 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)
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. Receives: Behavioral: Acupuncture; Drug: Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Medical Research Council (mMRC) Dyspnea Scale
Change in dyspnea severity measured by the Modified Medical Research Council (mMRC) Dyspnea Scale from baseline to 6 weeks.
Measured: From baseline to the end of treatment at 6 weeks
Secondary outcomes (6)
COPD Assessment Test (CAT)
Change in COPD Assessment Test (CAT) score.The CAT score evaluates overall symptom burden and quality of life in COPD patients.
Measured: From baseline to the end of treatment at 6 weeks
Change in Forced Expiratory Volume in 1 Second (FEV1)
FEV1 will be measured via spirometry pre- and post-bronchodilator to assess lung function
Measured: From baseline to the end of treatment at 6 weeks
6-Minute Walk Test (6MWT)
Change in exercise capacity measured by the 6-Minute Walk Test (6MWT) distance
Measured: From baseline to the end of treatment at 6 weeks
Incremental Shuttle Walk Test (ISWT)
Change in exercise tolerance assessed by the Incremental Shuttle Walk Test (ISWT)
Measured: From baseline to the end of treatment at 6 weeks
Change in Forced Vital Capacity (FVC)
FVC will be measured via spirometry pre- and post-bronchodilator to assess pulmonary capacity.
Measured: From baseline to the end of treatment at 6 weeks
Change in FEV1/FVC Ratio
The FEV1/FVC ratio will be calculated from spirometry values to evaluate airway obstruction severity.
Measured: From baseline to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start15 Nov 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058259
- Sponsor's protocol ID
- MU Acupuncture and COPD
- Acronym
- COPD
- Status last verified
- Jun 2025
- First submitted
- 22 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupuncture in COPD Patients With Persistent Dyspnea Despite Medical Treatment
- ClinicalTrials.gov ID
- NCT07058259
- Acronym / sponsor ID
- COPD / MU Acupuncture and COPD
- Keywords
- COPD, ACUPUNCTURE, dyspnea, chronic obstructive pulmonary disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 10 Jul 2025 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard COPD Pharmacological Treatment Group (Control) | Active comparator | Drug: Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS)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. |
| Acupuncture + Standard COPD Pharmacological Treatment Group (Intervention) | Experimental | Behavioral: Acupuncture, Drug: Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS)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) 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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,
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 |
|---|---|---|
| AcupunctureAcupuncture 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. | Behavioural | Acupuncture + Standard COPD Pharmacological Treatment Group (Intervention) |
| Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS)Also: Dual therapy (LAMA+LABA), Triple Therapy (LAMA+LABA+ICS)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. | Drug | Acupuncture + Standard COPD Pharmacological Treatment Group (Intervention), Standard COPD Pharmacological Treatment Group (Control) |
Primary outcome
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.
6 secondary outcomes
COPD Assessment Test (CAT)
Time frame: From baseline to the end of treatment at 6 weeks
Change in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: From baseline to the end of treatment at 6 weeks
6-Minute Walk Test (6MWT)
Time frame: From baseline to the end of treatment at 6 weeks
Incremental Shuttle Walk Test (ISWT)
Time frame: From baseline to the end of treatment at 6 weeks
Change in Forced Vital Capacity (FVC)
Time frame: From baseline to the end of treatment at 6 weeks
Change in FEV1/FVC Ratio
Time frame: From baseline to the end of treatment at 6 weeks
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 10 Jul 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Standard COPD Pharmacological Therapy (LAMA + LABA or LAMA + LABA + ICS) in people with COPD (Chronic Obstructive Pulmonary Disease) and Acupuncture, run by Istanbul Medeniyet University 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 5 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2025. 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?
Modified Medical Research Council (mMRC) Dyspnea Scale (time frame: From baseline to the end of treatment at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2025.