COPD ExacerbationNCT03398213
Acupuncture Treatment of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
A study testing Acupuncture in people with COPD Exacerbation, run by Bnai Zion Medical Center at 2 sites in Israel.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a major health problem. Acute exacerbations are a health-care burden involving frequent hospitalizations and elevated costs. They have effective therapies with significant side effects. Acupuncture has been shown to reduce dyspnea and other COPD-related symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesIsrael
- Study dates
- 14 Jan 2018to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous diagnosis of COPD
- Clinical diagnosis of acute exacerbation of COPD
- Informed consent
Who cannot join
- Hemodynamic instability
- Platelet count < 20 x 10^9/L
- Expected respiratory deterioration requiring mechanical ventilation in the next 24 hours
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Bnai Zion Medical Center
Haifa, Golomb 47, 3104802
Bnai Zion Medical Center
Haifa
About this study
Official title: Acupuncture Efficacy in the Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease During Hospitalization: a Randomized Controlled Trial
Chronic obstructive pulmonary disease (COPD) is a major health problem. Acute exacerbations are a health-care burden involving frequent hospitalizations and elevated costs. They have effective therapies with significant side effects. Acupuncture has been shown to reduce dyspnea and other COPD-related symptoms. The investigators will compare the efficacy and safety of the addition of true acupuncture to usual care with both sham-acupressure added to usual care and usual care only for the treatment of acute exacerbations of COPD among inpatients.
Read the detailed description
This is an assessor-blinded randomized controlled trial in the setting of a tertiary academic medical center in Israel. Patients with clinical diagnosis of acute exacerbation of COPD will be randomized to either usual care only, usual care with true acupuncture or usual care with sham-acupressure. The primary outcome will be clinical improvement of dyspnea as measured by mBorg scale. Secondary outcomes included improvement of other patient-reported outcomes and physiologic features, as well as duration of hospitalization and treatment failure. Acupuncture-related side effects will be evaluated by the validated Acupuncture Adverse Events (AcupAE) questionnaire.
- Conditions
- COPD Exacerbation
- Being tested
- Acupuncture, Sham procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Acupuncture
Sham procedureOther
Ear stimulation with plaster
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation Receives: Other: Acupuncture |
| Sham procedure | Sham comparator | Ear stimulation with plaster + standard conventional care for COPD exacerbation Receives: Other: Sham procedure |
| Standard care | No intervention | Standard conventional care for COPD exacerbation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea Intensity
modified Borg (mBorg) scale, which is a validated scale that has been used to evaluate the degree of dyspnea (0- no dyspnea, to 10- worse dyspnea)
Measured: At baseline, day 1 after treatment, day 2 before treatment, day 2 after treatment, day 3 before treatment, day 3 after treatment, day 4 before treatment, and day 4 after treatment
Secondary outcomes (7)
Duration of Hospitalization
Days of hospitalization
Measured: Through study completion, an average of 1 week
Carbon Dioxide Partial Pressure (pCO2)
pCO2
Measured: Day 1, day 2, day 3, and day 4 of the study
Power of Hydrogen (pH)
pH
Measured: Day 1, day 2, day 3, and day 4 of the study
Respiratory Rate
Respiratory rate
Measured: At baseline, day 1 after treatment, day 2 before treatment, day 2 after treatment, day 3 before treatment, day 3 after treatment, day 4 before treatment, and day 4 after treatment
Oxygen Saturation
Oxygen saturation
Measured: Day 1, day 2, day 3, and day 4 of the study
Cough Intensity
Visual Analogue Scale (VAS) for cough (0- no cough, to 10- worse cough)
Measured: Day 1, day 2, day 3, and day 4 of the study
Sputum Intensity
Visual Analogue Scale (VAS) for sputum (0- no sputum, to 10- worse sputum)
Measured: Day 1, day 2, day 3, and day 4 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start14 Jan 2018
- Primary completion25 Dec 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Elad Schiff, M.D., Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398213
- Sponsor's protocol ID
- 0108-17-BNZ
- Status last verified
- Jun 2019
- First submitted
- 31 Dec 2017
- Last updated
- 21 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Levy I, Elimeleh Y, Gavrieli S, Attias S, Schiff A, Oliven A, Schiff E. Treatment of acute exacerbations of chronic obstructive pulmonary disease with acupuncture during hospitalization: a three-arm double-blinded randomized sham-controlled trial. Acupunct Med. 2022 Dec;40(6):505-515. doi: 10.1177/09645284221086293. Epub 2022 May 17.
PubMed 35579025
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Efficacy in the Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease During Hospitalization: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03398213
- Acronym / sponsor ID
- 0108-17-BNZ
- Conditions
- COPD Exacerbation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 14 Jan 2018 (actual)
- Primary completion
- 25 Dec 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 12 Jan 2018 (actual)
- Results
- Posted 11 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic obstructive pulmonary disease (COPD) is a major health problem. Acute exacerbations are a health-care burden involving frequent hospitalizations and elevated costs. They have effective therapies with significant side effects. Acupuncture has been shown to reduce dyspnea and other COPD-related symptoms. The investigators will compare the efficacy and safety of the addition of true acupuncture to usual care with both sham-acupressure added to usual care and usual care only for the treatment of acute exacerbations of COPD among inpatients.
Detailed description
This is an assessor-blinded randomized controlled trial in the setting of a tertiary academic medical center in Israel. Patients with clinical diagnosis of acute exacerbation of COPD will be randomized to either usual care only, usual care with true acupuncture or usual care with sham-acupressure. The primary outcome will be clinical improvement of dyspnea as measured by mBorg scale. Secondary outcomes included improvement of other patient-reported outcomes and physiologic features, as well as duration of hospitalization and treatment failure. Acupuncture-related side effects will be evaluated by the validated Acupuncture Adverse Events (AcupAE) questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Other: AcupunctureAcupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation |
| Sham procedure | Sham comparator | Other: Sham procedureEar stimulation with plaster + standard conventional care for COPD exacerbation |
| Standard care | No intervention | –Standard conventional care for COPD exacerbation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Previous diagnosis of COPD
- Clinical diagnosis of acute exacerbation of COPD
- Informed consent
Key exclusion criteria (3 listed)
- Hemodynamic instability
- Platelet count < 20 x 10^9/L
- Expected respiratory deterioration requiring mechanical ventilation in the next 24 hours
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 | Other | Acupuncture |
| Sham procedureEar stimulation with plaster | Other | Sham procedure |
Primary outcome
Dyspnea Intensity
Time frame: At baseline, day 1 after treatment, day 2 before treatment, day 2 after treatment, day 3 before treatment, day 3 after treatment, day 4 before treatment, and day 4 after treatment
modified Borg (mBorg) scale, which is a validated scale that has been used to evaluate the degree of dyspnea (0- no dyspnea, to 10- worse dyspnea)
7 secondary outcomes
Duration of Hospitalization
Time frame: Through study completion, an average of 1 week
Carbon Dioxide Partial Pressure (pCO2)
Time frame: Day 1, day 2, day 3, and day 4 of the study
Power of Hydrogen (pH)
Time frame: Day 1, day 2, day 3, and day 4 of the study
Respiratory Rate
Time frame: At baseline, day 1 after treatment, day 2 before treatment, day 2 after treatment, day 3 before treatment, day 3 after treatment, day 4 before treatment, and day 4 after treatment
Oxygen Saturation
Time frame: Day 1, day 2, day 3, and day 4 of the study
Cough Intensity
Time frame: Day 1, day 2, day 3, and day 4 of the study
Sputum Intensity
Time frame: Day 1, day 2, day 3, and day 4 of the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35579025Levy I, Elimeleh Y, Gavrieli S, Attias S, Schiff A, Oliven A, Schiff E. Treatment of acute exacerbations of chronic obstructive pulmonary disease with acupuncture during hospitalization: a three-arm double-blinded randomized sham-controlled trial. Acupunct Med. 2022 Dec;40(6):505-515. doi: 10.1177/09645284221086293. Epub 2022 May 17.
- 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.
Elad Schiff, M.D. principal investigator
Bnai Zion Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with COPD Exacerbation, run by Bnai Zion Medical Center at 2 sites in Israel.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 11 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dyspnea Intensity (time frame: At baseline, day 1 after treatment, day 2 before treatment, day 2 after treatment, day 3 before treatment, day 3 after treatment, day 4 before treatment, and day 4 after treatment). 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 NCT03398213, which also lists 1 linked publication.
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 21 Aug 2020.