search
Back to results

Photobiomodulation in Individuals With Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low level laser therapy
Placebo group
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, Photobiomodulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Individuals of both sexes;
  • Over 18 years of age;
  • With a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) for at least 2 years according to the criteria of the clinically stable Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD), free of disease exacerbation in the last 30 days;
  • Performing routine outpatient treatment with a pulmonologist;
  • Agreement to participate.

Exclusion Criteria:

  • Individuals with other comorbidities, such as: Acute Lung Disease, Congestive Heart Failure, Liver Failure, Pulmonary Thromboembolism, Acute Respiratory Distress Syndrome, Neoplasms, HIV Positive, Immunodeficiency, Blood Disorders, Septicemia or recent major surgery.
  • Patients with cystic fibrosis and Kartagner's syndrome.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Control group

    Laser group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Measure of functional capacity
    Walk test: In a flat hallway, it will be delimited by two cones and the patient will be guided to walk from one side to the other. The walking speed will be controlled by a "compact disc" that emits beeps (simple BIP) at regular intervals. The test will be interrupted by exhaustion or when the patient is unable to maintain the proposed speed.

    Secondary Outcome Measures

    TNF-α, IL-1β, IL-6, IL-8, IL-17, IL-10 e IFN-α
    Quantification of serum levels of interleukin will be performed using Human IL-10 and THF-alpha ELISA MAX (Biolegend) according to the manufacturer's instructions. Briefly, the plates will be coated with anti-IL-10 or anti-TNF-alpha capture monoclonal antibody for 18 h at 8 ° C, washed and then incubated with the reagent provided by the kit to block non-specific binding and to reduce background. Samples will be added to each well at room temperature for 2 h and after washing, the detection antibody solution will be added. The reactions will be revealed with the Avidin-HRP solution and the absorbance will be read at 450nm. They will be evaluated immediately after the end of treatment.
    Spirometry
    The spirometry test will be performed by a physiotherapist using a spirometer apparatus to perform spirometry before and after 20 minutes of bronchodilator administration. The technical procedures, the criteria of acceptability and reproducibility adopted will be those recommended by the Brazilian Consensus of Spirometry. All patients will perform the maneuvers after bronchodilator (salbutamol 400 μg inhalation). They will be evaluated immediately after the end of treatment.
    Quality of life assessment questionnaire
    Saint George's Respiratory Questionnaire (SGRQ): We apply questions related to daily life activities related to the quality of life of patients with COPD. They will be evaluated immediately after the end of treatment. The SGRQ addresses aspects related to three areas: symptoms, activity and psychosocial impacts that respiratory disease inflicts on the patient. Each domain has a maximum possible score; the points of each answer are summed and the total is referred to as a percentage of this maximum.

    Full Information

    First Posted
    April 25, 2019
    Last Updated
    July 4, 2019
    Sponsor
    University of Nove de Julho
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04010084
    Brief Title
    Photobiomodulation in Individuals With Chronic Obstructive Pulmonary Disease
    Official Title
    Effectiveness of Photobiomodulation in Individuals With Chronic Obstructive Pulmonary Disease - Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2019 (Anticipated)
    Primary Completion Date
    March 1, 2020 (Anticipated)
    Study Completion Date
    June 3, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Nove de Julho

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Chronic obstructive pulmonary disease (COPD) is among the most common chronic respiratory diseases (CKD). Millions of people of all ages suffer from these diseases. COPD is between the fifth and sixth of the leading causes of death in Brazil. It generates an inflammatory pulmonary response that is softened by non-curative treatments and that present serious side effects. Low intensity laser (LBI) or laser therapy has been used for about 50 years to help the healing process, revealing efficient anti-inflammatory and analgesic responses, as well as experimental models of acute and chronic inflammation. However, little is known about its response in inflammatory lung diseases, especially COPD. Some reports indicate that laser therapy may interfere positively by relieving clinical signs, the onset, and the final symptoms of pulmonary inflammation. The present project aims to study the effects of LBI on Chronic Obstructive Pulmonary Disease in patients with pulmonary processes, determine their mechanisms of action and evaluate its effect on patients' functional capacity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease
    Keywords
    Chronic Obstructive Pulmonary Disease, Photobiomodulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    the participant will be randomized through a raffle without knowing which group has the active intervention or placebo.
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Title
    Laser group
    Arm Type
    Active Comparator
    Intervention Type
    Radiation
    Intervention Name(s)
    Low level laser therapy
    Intervention Description
    The irradiation will be applied transcutaneously in the sublingual region (3 points on the left side and 3 points on the right side), irradiated for 30 seconds and the total treatment time will be 3 minutes. The group will receive irradiation with a DMC-branded laser EC device, with combined wavelength (660 and 780 nm), 1J of energy per point and output power of 35 mW. A disposable plastic material covering the application pen will be used for hygiene reasons. The treatment will be performed twice weekly for a total of 4 consecutive weeks of treatment, and after completion, the patients will be reassessed of all the complementary tests that have been requested.
    Intervention Type
    Procedure
    Intervention Name(s)
    Placebo group
    Intervention Description
    The irradiation will be applied transcutaneously in the sublingual region (3 points on the left side and 3 points on the right side), irradiated for 30 seconds and the total treatment time will be 3 minutes. The group will receive placebo (with switched-off) irradiation of the DMC-brand laser therapy EC model, with combined wavelength (660 and 780 nm), 1J of energy per point and output power of 35 mW. A disposable plastic material covering the application pen will be used for hygiene reasons. The treatment will be performed twice weekly for a total of 4 consecutive weeks of treatment, and after completion, the patients will be reassessed of all the complementary tests that have been requested.
    Primary Outcome Measure Information:
    Title
    Measure of functional capacity
    Description
    Walk test: In a flat hallway, it will be delimited by two cones and the patient will be guided to walk from one side to the other. The walking speed will be controlled by a "compact disc" that emits beeps (simple BIP) at regular intervals. The test will be interrupted by exhaustion or when the patient is unable to maintain the proposed speed.
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    TNF-α, IL-1β, IL-6, IL-8, IL-17, IL-10 e IFN-α
    Description
    Quantification of serum levels of interleukin will be performed using Human IL-10 and THF-alpha ELISA MAX (Biolegend) according to the manufacturer's instructions. Briefly, the plates will be coated with anti-IL-10 or anti-TNF-alpha capture monoclonal antibody for 18 h at 8 ° C, washed and then incubated with the reagent provided by the kit to block non-specific binding and to reduce background. Samples will be added to each well at room temperature for 2 h and after washing, the detection antibody solution will be added. The reactions will be revealed with the Avidin-HRP solution and the absorbance will be read at 450nm. They will be evaluated immediately after the end of treatment.
    Time Frame
    4 weeks
    Title
    Spirometry
    Description
    The spirometry test will be performed by a physiotherapist using a spirometer apparatus to perform spirometry before and after 20 minutes of bronchodilator administration. The technical procedures, the criteria of acceptability and reproducibility adopted will be those recommended by the Brazilian Consensus of Spirometry. All patients will perform the maneuvers after bronchodilator (salbutamol 400 μg inhalation). They will be evaluated immediately after the end of treatment.
    Time Frame
    4 weeks
    Title
    Quality of life assessment questionnaire
    Description
    Saint George's Respiratory Questionnaire (SGRQ): We apply questions related to daily life activities related to the quality of life of patients with COPD. They will be evaluated immediately after the end of treatment. The SGRQ addresses aspects related to three areas: symptoms, activity and psychosocial impacts that respiratory disease inflicts on the patient. Each domain has a maximum possible score; the points of each answer are summed and the total is referred to as a percentage of this maximum.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Individuals of both sexes; Over 18 years of age; With a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) for at least 2 years according to the criteria of the clinically stable Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD), free of disease exacerbation in the last 30 days; Performing routine outpatient treatment with a pulmonologist; Agreement to participate. Exclusion Criteria: Individuals with other comorbidities, such as: Acute Lung Disease, Congestive Heart Failure, Liver Failure, Pulmonary Thromboembolism, Acute Respiratory Distress Syndrome, Neoplasms, HIV Positive, Immunodeficiency, Blood Disorders, Septicemia or recent major surgery. Patients with cystic fibrosis and Kartagner's syndrome.

    12. IPD Sharing Statement

    Learn more about this trial

    Photobiomodulation in Individuals With Chronic Obstructive Pulmonary Disease

    We'll reach out to this number within 24 hrs