Bacterial Colonization in COPD in View of CAT Under ICS+LABA Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-06-30

Brief Summary

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Patients with COPD (chronic obstructive pulmonary disease) suffer from episodes of acute exacerbations leading to additional morbidity and mortality, and also a further decline in lung function. It has been well-established that bacterial colonization is prevalent in COPD, especially in moderate to severe COPD, and airway bacterial colonization is known to play an important role in the development of pneumonia and exacerbations. On the other way, inhaled corticosteroid (ICS) and long acting β2 agonist (LABA) were recommended in the treatment of moderate to severe COPD. Though there were some evidences that ICS had some protective effects on airway mucosa against bacteria invasion, the locally immunosuppressive effects of ICS is still a concern. Indeed, the incidence of pneumonia was higher than the control group, not only in the Towards a Revolution in COPD Health (TORCH) study but also in various studies and meta-analyses.We hypothesized that airway bacteria colonization is associated with disease severity, and that disease status can be identified by CAT (COPD assessment test)scores and changes of CAT scores. We therefore conducted this prospective, observational study in which CAT scores and sputum cultures were assessed in moderate to severe COPD patients with the combination therapy of ICS and LABA every three months during the study period. The primary end-point is the condition of potential pathogenic microorganisms (PPM) colonization in view of CAT scores. The second end-point was the changes of PPM colonization in association with CAT changes during follow-up. By the mean of CAT follow-up, it could possibly provide a surrogate about the risk of exacerbation and pneumonia under the combination therapy of ICS and LABA.

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Detailed Description

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Conditions

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Bacterial Infections Chronic Obstructive Pulmonary Disease Self-Assessment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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bacteria colonization in CAT less 20

the incidence of sputum potential pathogenic microoragnism in patients with CAT scores less than 20

No interventions assigned to this group

the PPM in change of CAT >2

the change of potential pathogenic microorganism in CAT difference more than 2 while follow-up

No interventions assigned to this group

the change of CAT<=2

the change of potential pathogenic microorganism in CAT difference less than or equal to 2 while follow-up

No interventions assigned to this group

PPM in CAT>=20

the incidence of sputum potential pathogenic microoragnism in patients with CAT scores more than or equal to 20

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* spirometry showed obstructive ventilatory defect (a ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) of less than 0.7) and FEV1 less than 80% of predicted value and patients receiving the combination therapy of ICS and LABA

Exclusion Criteria

* (1) use of antibiotics or corticosteroids within eight weeks before study entry; (2) pneumoconiosis; (3) apparent inactive tuberculosis fibrosis (fibrosis involved in more than one third of one lung field as determined by chest radiography); and (4) asthma and atopic history.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No