Chronic Obstructive Pulmonary DiseaseNCT01213693
Effects of Inhaled Corticosteroids on Sputum Bacterial Load in COPD
A study testing Salmeterol/Fluticasone combination and Salmeterol in people with Chronic Obstructive Pulmonary Disease, run by Università degli Studi di Ferrara at 1 site in Italy.
Trial summary
Exacerbations are important events in the natural history of chronic obstructive pulmonary disease (COPD). Beside the acute (and prolonged) clinical impact, there is evidence that exacerbations negatively affect the natural history of the disease; e.g. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Salmeterol/Fluticasone combination and Salmeterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- May 2009to Nov 2013
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sixty stable moderate COPD patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2) requiring regular treatment with long-acting bronchodilators, according to international guidelines.
- GOLD stage 2 COPD patients will be enrolled providing they were steroid-free for the last 4 months
Who cannot join
- Atopy
- Asthma
- Concomitant lung diseases (e.g. lung cancer)
- Acute infections of the respiratory tree in the previous 3 months including COPD exacerbation.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Research Centre on Asthma and COPD - Department of Clinical and Experimental Medicine - Section of Respiratory Disease - University of Ferrara
Ferrara, 44121
About this study
Official title: Long-term Effects of Inhaled Corticosteroids (ICS) Treatment on Sputum Bacterial and Viral Loads in Chronic Obstructive Pulmonary Disease (COPD) Patients
Exacerbations are important events in the natural history of chronic obstructive pulmonary disease (COPD). Beside the acute (and prolonged) clinical impact, there is evidence that exacerbations negatively affect the natural history of the disease; e.g. lung function decline is accelerated in patients with frequent exacerbations. Bacteria are considered the most relevant cause of exacerbations, but there is evidence that viral infections are equally contributing.
Either alone or in combination with viruses, airway bacterial load in stable COPD correlates with both the frequency of exacerbations and the decline in lung function.
Read more
A long-term clinical trial recently showed that the regular treatment with inhaled corticosteroids (ICS) increases the risk of infectious events such as pneumonia, whereas it reduces the frequency of acute COPD exacerbations in COPD.
In a recent study it was found that airway bacterial load increases over time (1 yr follow up) in stable COPD. In this study, virtually all patients (93%) were treated with ICS.
This study is designed to evaluate whether long-term (1 year) ICS treatment increases viral and/or bacterial load in the sputum of COPD patients.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Salmeterol/Fluticasone combination, Salmeterol
- Keywords
- COPD, Bacteria, Virus, Inhaled Corticosteroids
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmeterol/Fluticasone combinationDrug
Salmeterol/Fluticasone 50/500 mcg 1 inhalation bid
SalmeterolDrug
Salmeterol 50 mcg 1 inhalation bid
| Study group | Role | What they receive |
|---|---|---|
| ICS/LABA group | Experimental | Patients assigned to this arm will take bid 50/500 mcg fluticasone/salmeterol combination Receives: Drug: Salmeterol/Fluticasone combination |
| LABA group | Active comparator | Patients assigned to this arm will take bid 50 mcg salmeterol Receives: Drug: Salmeterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison between groups of bacterial load in sputum
The primary outcome will measure changes in sputum bacterial load of COPD patients treated with inhaled corticosteroids in combination with long acting beta-2 bronchodilators (ICS/LABA group) compared with COPD treated only with long acting beta-2 bronchodilators (LABA group)
Measured: 1 year
Secondary outcomes (4)
Correlations between clinical outcomes and sputum viral and/or bacterial load
To evaluate whether sputum viral and/or bacterial load correlate with symptoms and need for rescue medication in stabile COPD.
Measured: 1 year
Sputum viral and/or bacterial load and exacerbation rate
To evaluate whether changes in sputum viral and/or bacterial load (end of the study vs baseline) correlate with exacerbation rate in COPD patients
Measured: 1 year
Sputum viral and/or bacterial load and lung function
To evaluate correlations between changes in sputum viral and/or bacterial load and changes in lung function over 1 year.
Measured: 1 year
Airway inflammation and viral/bacterial load in COPD
To evaluate correlations between sputum inflammatory cell profiles and markers of airway inflammation (interleukin-6) and viral/bacterial load at stable stable conditions in COPD paetints.
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 posted4 Oct 2010 (estimated)
- Study startMay 2009
- Primary completionMay 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Alberto Papi, MD, Università degli Studi di Ferrara
- Investigators
- Alberto Papi, MD, Principal investigator, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213693
- Sponsor's protocol ID
- LTEICSBV01
- Status last verified
- Apr 2016
- First submitted
- 1 Oct 2010
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Contoli M, Pauletti A, Rossi MR, Spanevello A, Casolari P, Marcellini A, Forini G, Gnesini G, Marku B, Barnes N, Rizzi A, Curradi G, Caramori G, Morelli P, Papi A. Long-term effects of inhaled corticosteroids on sputum bacterial and viral loads in COPD. Eur Respir J. 2017 Oct 5;50(4):1700451. doi: 10.1183/13993003.00451-2017. Print 2017 Oct.
PubMed 28982774
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Inhaled Corticosteroids (ICS) Treatment on Sputum Bacterial and Viral Loads in Chronic Obstructive Pulmonary Disease (COPD) Patients
- ClinicalTrials.gov ID
- NCT01213693
- Acronym / sponsor ID
- LTEICSBV01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Bacteria, Virus, Inhaled Corticosteroids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- May 2009
- Primary completion
- May 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 4 Oct 2010 (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.
Exacerbations are important events in the natural history of chronic obstructive pulmonary disease (COPD). Beside the acute (and prolonged) clinical impact, there is evidence that exacerbations negatively affect the natural history of the disease; e.g. lung function decline is accelerated in patients with frequent exacerbations. Bacteria are considered the most relevant cause of exacerbations, but there is evidence that viral infections are equally contributing.
Either alone or in combination with viruses, airway bacterial load in stable COPD correlates with both the frequency of exacerbations and the decline in lung function.
A long-term clinical trial recently showed that the regular treatment with inhaled corticosteroids (ICS) increases the risk of infectious events such as pneumonia, whereas it reduces the frequency of acute COPD exacerbations in COPD.
In a recent study it was found that airway bacterial load increases over time (1 yr follow up) in stable COPD. In this study, virtually all patients (93%) were treated with ICS.
This study is designed to evaluate whether long-term (1 year) ICS treatment increases viral and/or bacterial load in the sputum of COPD patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICS/LABA group | Experimental | Drug: Salmeterol/Fluticasone combinationPatients assigned to this arm will take bid 50/500 mcg fluticasone/salmeterol combination |
| LABA group | Active comparator | Drug: SalmeterolPatients assigned to this arm will take bid 50 mcg salmeterol |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sixty stable moderate COPD patients (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2) requiring regular treatment with long-acting bronchodilators, according to international guidelines.
- GOLD stage 2 COPD patients will be enrolled providing they were steroid-free for the last 4 months
Key exclusion criteria (4 listed)
- Atopy
- Asthma
- Concomitant lung diseases (e.g. lung cancer)
- Acute infections of the respiratory tree in the previous 3 months including COPD exacerbation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salmeterol/Fluticasone combinationSalmeterol/Fluticasone 50/500 mcg 1 inhalation bid | Drug | ICS/LABA group |
| SalmeterolSalmeterol 50 mcg 1 inhalation bid | Drug | LABA group |
Primary outcome
comparison between groups of bacterial load in sputum
Time frame: 1 year
The primary outcome will measure changes in sputum bacterial load of COPD patients treated with inhaled corticosteroids in combination with long acting beta-2 bronchodilators (ICS/LABA group) compared with COPD treated only with long acting beta-2 bronchodilators (LABA group)
4 secondary outcomes
Correlations between clinical outcomes and sputum viral and/or bacterial load
Time frame: 1 year
Sputum viral and/or bacterial load and exacerbation rate
Time frame: 1 year
Sputum viral and/or bacterial load and lung function
Time frame: 1 year
Airway inflammation and viral/bacterial load in COPD
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 8 Apr 2016.
- Derived from this study: PubMed 28982774Contoli M, Pauletti A, Rossi MR, Spanevello A, Casolari P, Marcellini A, Forini G, Gnesini G, Marku B, Barnes N, Rizzi A, Curradi G, Caramori G, Morelli P, Papi A. Long-term effects of inhaled corticosteroids on sputum bacterial and viral loads in COPD. Eur Respir J. 2017 Oct 5;50(4):1700451. doi: 10.1183/13993003.00451-2017. Print 2017 Oct.
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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.
Alberto Papi, MD principal investigator
Università degli Studi di Ferrara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salmeterol/Fluticasone combination and Salmeterol in people with Chronic Obstructive Pulmonary Disease, run by Università degli Studi di Ferrara at 1 site in Italy.
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 2 inclusion and 4 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 8 Apr 2016. 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 Italy. 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?
comparison between groups of bacterial load in sputum (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01213693, which also lists 1 linked publication.
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 8 Apr 2016.