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

The Influence on Airway Bacteria Colonization in Chronic Obstructive Pulmonary Disease by the Combination of Inhaled Corticosteroid and Long-acting β2 Agonist

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Bacterial Infections; Self-Assessment

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei, Taiwan, 220
    • Far Eastern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

COPD under ICS+LABA combination therapy and FEV1<80% and FEV1/FVC<70%

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
bacteria colonization in CAT less 20; the incidence of sputum potential pathogenic microoragnism in patients with CAT scores less than 20
the PPM in change of CAT >2; the change of potential pathogenic microorganism in CAT difference more than 2 while follow-up
the change of CAT<=2; the change of potential pathogenic microorganism in CAT difference less than or equal to 2 while follow-up
PPM in CAT>=20; the incidence of sputum potential pathogenic microoragnism in patients with CAT scores more than or equal to 20

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
potential pathogenic microorganisms colonization in view of CAT scores	Sputum bacterial cultures after sputum induction,and CAT at the start of the study and every three months until the end of the study period	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
the changes of PPM colonization in association with CAT changes during follow-up.	1 year

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital
• Investigators: Principal Investigator: Ping-huai Wang, M.D, Far Eastern Memorial Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: March 18, 2013
• First Submitted That Met QC Criteria: March 22, 2013
• First Posted (Estimate): March 27, 2013

Study Record Updates

• Last Update Posted (Estimate): March 27, 2013
• Last Update Submitted That Met QC Criteria: March 22, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Bacterial Infections and Mycoses; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Bacterial Infections
• Other Study ID Numbers: FEMH - 2011 - C25