免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / The Effect of Bronchiectasis on the Exacerbation and Mortality in COPD
The Effect of Bronchiectasis on the Exacerbation and Mortality in COPD
Study Description
Brief Summary:
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the airways and lungs that develops against harmful particles or gases with exacerbations. Coexistence of bronchiectasis with COPD may lead to worsening of the functional parameters as well as alteration of the microbiological pattern in exacerbations and may negatively affect the exacerbation result parameters.
| Condition or disease | Intervention/treatment |
|---|---|
| Bronchiectasis Chronic Obstructive Pulmonary Disease | Other: No intervention |
Detailed Description:
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the airways and lungs that develops against harmful particles or gases with exacerbations. COPD exacerbations are characterized by worsening of dyspnea, coughing and expectoration. Exacerbations requiring hospitalization are the main cause of morbidity and mortality in COPD. Bronchiectasis is the irreversible extension of the bronchi. Usually follows with chronic sputum cough, airway obstruction and recurrent infection episodes. The association of bronchiectasis and COPD has long been known and its incidence is in the range of 30-50%. Coexistence of bronchiectasis with COPD may lead to worsening of the functional parameters as well as alteration of the microbiological pattern in exacerbations and may negatively affect the exacerbation result parameters.
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 122 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | The Effect of Bronchiectasis on the Exacerbation and Mortality of Chronic Obstructive Pulmonary Disease |
| Actual Study Start Date : | January 25, 2010 |
| Actual Primary Completion Date : | December 25, 2014 |
| Actual Study Completion Date : | January 25, 2017 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
COPD exacerbation without Bronchiectasis
COPD patients who have been in exacerbation period and have no bronchiectasis
|
Other: No intervention |
|
COPD exacerbation with Bronchiectasis
COPD patients who have been in exacerbation period and have bronchiectasis
|
Other: No intervention |
Outcome Measures
Primary Outcome Measures :
- Charlson Comorbidity Index [ Time Frame: 1 hour ]Comorbidity scores
Secondary Outcome Measures :
- Spirometry [ Time Frame: 1 hour ]Pulmonary function measurement
Eligibility Criteria
| Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patient with COPD exacerbation
Criteria
Inclusion Criteria:
- Patients who underwent thoracic tomography in the last year according to index exacerbation date were included in the study
Exclusion Criteria:
- Cases that mimic COPD exacerbation (pneumonia, pulmonary thromboembolism, pulmonary congestion, pneumothorax, pleural effusion, lung malignancy, asthma, asthma-COPD overlap syndrome) and patients admitted to the intensive care unit were excluded from the study.
Contacts and Locations
Sponsors and Collaborators
Ministry of Health, Turkey
Investigators
| Study Chair: | Nurdan Kokturk, Professor | Gazi University Faculty of Medicine |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 13, 2019 | ||||
| First Posted Date | May 15, 2019 | ||||
| Last Update Posted Date | May 17, 2019 | ||||
| Actual Study Start Date | January 25, 2010 | ||||
| Actual Primary Completion Date | December 25, 2014 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Charlson Comorbidity Index [ Time Frame: 1 hour ] Comorbidity scores
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
Spirometry [ Time Frame: 1 hour ] Pulmonary function measurement
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | The Effect of Bronchiectasis on the Exacerbation and Mortality in COPD | ||||
| Official Title | The Effect of Bronchiectasis on the Exacerbation and Mortality of Chronic Obstructive Pulmonary Disease | ||||
| Brief Summary | Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the airways and lungs that develops against harmful particles or gases with exacerbations. Coexistence of bronchiectasis with COPD may lead to worsening of the functional parameters as well as alteration of the microbiological pattern in exacerbations and may negatively affect the exacerbation result parameters. | ||||
| Detailed Description | Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease of the airways and lungs that develops against harmful particles or gases with exacerbations. COPD exacerbations are characterized by worsening of dyspnea, coughing and expectoration. Exacerbations requiring hospitalization are the main cause of morbidity and mortality in COPD. Bronchiectasis is the irreversible extension of the bronchi. Usually follows with chronic sputum cough, airway obstruction and recurrent infection episodes. The association of bronchiectasis and COPD has long been known and its incidence is in the range of 30-50%. Coexistence of bronchiectasis with COPD may lead to worsening of the functional parameters as well as alteration of the microbiological pattern in exacerbations and may negatively affect the exacerbation result parameters. | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patient with COPD exacerbation | ||||
| Condition |
|
||||
| Intervention | Other: No intervention | ||||
| Study Groups/Cohorts |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
122 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | January 25, 2017 | ||||
| Actual Primary Completion Date | December 25, 2014 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| Ages | 40 Years to 70 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03950531 | ||||
| Other Study ID Numbers | 123678 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement |
|
||||
| Responsible Party | Zeynep FENDOGLU, Ministry of Health, Turkey | ||||
| Study Sponsor | Ministry of Health, Turkey | ||||
| Collaborators | Not Provided | ||||
| Investigators |
|
||||
| PRS Account | Ministry of Health, Turkey | ||||
| Verification Date | May 2019 | ||||
