Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bronchiectasis Effect in COPD Patients

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03670940
Recruitment Status : Completed
First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Ilknur Naz, Izmir Katip Celebi University

Brief Summary:
The etiology of bronchiectasis, known as permanent, abnormal, and localized development of bronchi, varies. However, most of them are responsible for infections during childhood. The prevalence of bronchiectasis is particularly high in advanced COPD patients. This phenomenon, called COPD-bronchiectasis overlap syndrome, affects the clinic of COPD patients negatively. In this study; bronchiectasis in respiratory function, exercise capacity, dyspnoea and quality of life in COPD patients.

Condition or disease
Bronchiectasis Copd

Detailed Description:

The etiology of bronchiectasis, known as permanent, abnormal, and localized development of bronchi, varies. However, most of them are responsible for infections during childhood. The prevalence of bronchiectasis is particularly high in advanced COPD patients. This phenomenon, called COPD-bronchiectasis overlap syndrome, affects the clinic of COPD patients negatively. In this study; bronchiectasis in respiratory function, exercise capacity, dyspnoea and quality of life in COPD patients.

Torax CTs of patients with COPD who are admitted to the outpatient clinic will be examined. There will be two groups, group 1 in patients with COPD accompanied by bronchiectasis and group 2 in COPD patients without bronchiectasis. In both groups, respiratory function tests, exercise capacities, dyspnea perceptions and quality of life will be evaluated. The data will be compared between the two groups.


Layout table for study information
Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effect of Bronchiectasis on Respiratory Functions, Exercise Capacity, Dyspnea Perception and Quality of Life in COPD Patients
Actual Study Start Date : January 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Group/Cohort
COPD patients
COPD patients without bronchiectasis
COPD and bronchiectasis patients
COPD patients with bronchiectasis



Primary Outcome Measures :
  1. Exercise capacity [ Time Frame: 15 minutes ]
    six minute walk test


Secondary Outcome Measures :
  1. Dyspnea Severity [ Time Frame: 5 minutes ]
    mMRC Dyspnea Scale (0: no dyspnea, 4: very severe dyspnea)

  2. Lung Function [ Time Frame: 20 minutes ]
    Respiratory Function Test

  3. Health Related Quality of Life [ Time Frame: 25 minutes ]
    St. George Respiratory Questionnaire (maximum score: 100, lower score means better quality of life)



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COPD patients with and without bronchiectasis.
Criteria

Inclusion Criteria:

  • above 18 years old
  • clinically stable

Exclusion Criteria:

  • other respiratory disease

Layout table for additonal information
Responsible Party: Ilknur Naz, Asst. Prof., Izmir Katip Celebi University
ClinicalTrials.gov Identifier: NCT03670940     History of Changes
Other Study ID Numbers: IKC
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases