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Predicting Risk Factors for Exacerbation of Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT03450603
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
Exacerbations of chronic obstructive pulmonary disease (COPD) are unfavourable events in the course of disease for most COPD patients. Published evidence indicates a significant impact of exacerbations, especially if frequent, on patients' health-related quality of life (HRQL), disease progression, mortality, health care utilisation and costs. However, the severity,evolution and outcome of an exacerbation may differ significantly between patients - some patients will recover completely in a short period of time while others may die. The identification of risk factors for an adverse outcome could help in distinguishing patients who require more intense management in order to prevent failures, achieve satisfactory recovery and reduce the negative clinical and socioeconomic impact of exacerbations.

Condition or disease
Chronic Obstructive Pulmonary Disease

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: It is Crucial to Identify Predicting Risk Factors for Exacerbation of Chronic Obstructive Pulmonary Disease in Order to Provide Adequate Intensive Therapy and Closer Follow-up
Actual Study Start Date : December 10, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort
stable COPD
Chronic obstructive pulmonary disease (COPD) was confirmed if the patient had a baseline post-bronchodilator FEV1 less than 80% of the reference value and forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) quotient of less than 70%.Select patients with COPD without acute attack within three months.
exacerbation of COPD
Exacerbation was defined as an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough, and/or sputum that was beyond normal day to day variations and may have warranted a change in regular medication in a patient with underlying COPD.



Primary Outcome Measures :
  1. Number of participants with acute exacerbations of chronic obstructive pulmonary disease [ Time Frame: one year ]
    Acute exacerbations of chronic obstructive pulmonary disease is defined as an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough, and/or sputum that is beyond normal day to day variations and may have warranted a change in regular medication in a patient with underlying COPD.


Biospecimen Retention:   Samples With DNA
Investigators will collect the fasting venous blood . White blood cell,C-reactive protein, interleukin-6, -8, -10 and tumor necrosis factor-a will be determined.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female subjects aged >40 years,baseline post-bronchodilator FEV1 less than 80% of the reference value and FEV1/FVC of less than or equal to 0.7, when clinically stable or Exacerbation; current,ex-smokers or no smokers. Exclusion Criteria:Participants had COPD complicated by a comorbidity such as pneumothorax, pulmonary embolism, lung cancer, or left cardiac insufficiency. Other exclusion criteria included a diagnosis of asthma, extensive bronchiectasis, sequelae of tuberculosis, interstitial lung disease, or restrictive disease.
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Chronic obstructive pulmonary disease
  • aged >= 40 years

Exclusion Criteria:

  • spirometry can not be completed because of various reasons
  • asthma
  • pulmonary embolism
  • lung cancer
  • sequelae of tuberculosis
  • extensive bronchiectasis
  • interstitial lung disease
  • left cardiac insufficiency

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): NCT03450603


Contacts
Contact: Yue Zhang +86-21-25077373 zhangyue01@xinhuamed.com.cn

Locations
China
Department of Respiratory Medicine, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, China, 200092
Contact: Yue Zhang    +86-21-25077373    zhangyue01@xinhuamed.com.cn   
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03450603     History of Changes
Other Study ID Numbers: XH-17-019
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: December 2017

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