Bacterial InfectionsNCT01819298
Bacterial Colonization in COPD in View of CAT Under ICS+LABA Therapy
An observational study of Bacterial Infections and Chronic Obstructive Pulmonary Disease, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bacterial Infections, Chronic Obstructive Pulmonary Disease, Self-Assessment
- How many people
- 17 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD under ICS+LABA combination therapy and FEV1<80% and FEV1/FVC<70%
Who may be able to join
- 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
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Medical subject headings
- Bacterial Infections, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Secondary outcomes (1)
the changes of PPM colonization in association with CAT changes during follow-up.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startMar 2011
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping-Huai Wang, Far Eastern Memorial Hospital
- Investigators
- Ping-huai Wang, M.D, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819298
- Sponsor's protocol ID
- FEMH - 2011 - C25
- Status last verified
- Mar 2013
- First submitted
- 18 Mar 2013
- Last updated
- 27 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence on Airway Bacteria Colonization in Chronic Obstructive Pulmonary Disease by the Combination of Inhaled Corticosteroid and Long-acting β2 Agonist
- ClinicalTrials.gov ID
- NCT01819298
- Acronym / sponsor ID
- FEMH - 2011 - C25
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD under ICS+LABA combination therapy and FEV1<80% and FEV1/FVC<70%
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
the changes of PPM colonization in association with CAT changes during follow-up.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping-huai Wang, M.D principal investigator
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infections and Chronic Obstructive Pulmonary Disease, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
potential pathogenic microorganisms colonization in view of CAT scores (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2013.