We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acupuncture Treatment of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03398213
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment
COPD Exacerbation Other: Acupuncture Other: Sham procedure

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 as measured by validated diaries. Secondary outcomes will include duration of hospitalization and improvement of objective features (Forced Expiratory Volume in the first second (FEV1), oxygen saturation, respiratory rate, blood gases). Acupuncture-related side effects will be evaluated by the validated Acupuncture Adverse Events (AcupAE) questionnaire.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease With Acupuncture Compared With Sham-acupuncture During Hospitalization
Actual Study Start Date : November 25, 2017
Estimated Primary Completion Date : October 25, 2018
Estimated Study Completion Date : October 25, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Acupuncture
Acupuncture for treatment of COPD exacerbation + standard conventional care for COPD exacerbation
Other: Acupuncture
Acupuncture
Sham Comparator: Sham procedure
Ear stimulation with plaster + standard conventional care for COPD exacerbation
Other: Sham procedure
Ear stimulation with plaster
No Intervention: Standard care
Standard conventional care for COPD exacerbation


Outcome Measures

Primary Outcome Measures :
  1. Clinical improvement [ Time Frame: At baseline, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 of the study ]
    EXAcerbations of Chronic pulmonary disease Patient-Reported Outcome (EXACT-PRO) diary: this scale quantifies and measures symptoms of COPD exacerbation on a 0-56 scale (patients answer 14 questions rated from 0 to 4 each). The total value will be reported and higher values represent worse prognosis.


Secondary Outcome Measures :
  1. Duration of hospitalization [ Time Frame: Through study completion, an average of 1 week ]
    Days of hospitalization

  2. FEV1 [ Time Frame: Through study completion, an average of 1 week ]
    FEV1

  3. Carbon dioxide partial pressure (pCO2) [ Time Frame: At baseline, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 of the study ]
    pCO2

  4. Power of hydrogen (pH) [ Time Frame: At baseline, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 of the study ]
    pH

  5. Respiratory rate [ Time Frame: At baseline, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 of the study ]
    Respiratory rate

  6. Oxygen saturation [ Time Frame: At baseline, day 1, day 2, day 3, day 4, day 5, day 6 and day 7 of the study ]
    Oxygen saturation


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous diagnosis of COPD
  • Clinical diagnosis of acute exacerbation of COPD
  • Informed consent

Exclusion Criteria:

  • Hemodynamic instability
  • Platelet count < 20 x 10^9/L
  • International Normalized Ratio > 4.0
  • Partial Thromboplastin Time > 80 seconds
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398213


Contacts
Contact: Elad Schiff, M.D. 972-506267243 elad.schiff@b-zion.org.il
Contact: Ilana Levy, M.D. 972-525086128 ilana.e.levy@gmail.com

Locations
Israel
Bnai Zion Medical Center Recruiting
Haifa, Golomb 47, Israel, 3104802
Contact: Ilana Levy, M.D.    972-525086128    ilana.e.levy@gmail.com   
Bnai Zion Medical Center Recruiting
Haifa, Israel
Contact: ELAD SCHIFF    972506267243    ESCHIFF@BEZEQINT.NET   
Principal Investigator: ELAD SCHIFF, PI         
Sponsors and Collaborators
Bnai Zion Medical Center
Investigators
Principal Investigator: Elad Schiff, M.D. Bnai Zion Medical Center
More Information

Responsible Party: Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT03398213     History of Changes
Other Study ID Numbers: 0108-17-BNZ
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases