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OpenTrials
Completed

NCT Number: NCT01819298

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

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. potential pathogenic microorganisms colonization in view of CAT scores

    Time frame: one year

    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

Secondary outcomes

  1. the changes of PPM colonization in association with CAT changes during follow-up.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 27, 2013
Registry last updated
Mar 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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