Chronic Obstructive Pulmonary DiseaseNCT01216592
Airway Inflammation, Symptoms and Lung Function in COPD
An observational study of Chronic Obstructive Pulmonary Disease, run by Università degli Studi di Ferrara at 1 site in Italy.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease with high prevalence worldwide and with relevant impact on patient-related quality of life, morbidity and mortality. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- COPD treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2009to Jul 2011
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Moderate to severe COPD patients (according to GOLD guidelines) will be enrolled in the study
Who may be able to join
- Post-bronchodilator FEV1/FVC ratio < 70%
- Post-bronchodilator FEV1 < 80%
- Smokers or ex-smoker with pack/years > 15
Who cannot join
- Atopy
- Asthma
- Concomitant lung diseases (e.g. lung cancer)
- Acute infections of the respiratory tree in the previous 2 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: Correlations Between Airway Inflammation, Symptoms and Lung Functions in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease with high prevalence worldwide and with relevant impact on patient-related quality of life, morbidity and mortality. There is evidence that airway inflammation correlates with the severity of the disease and that airway inflammation is further enhanced during exacerbation. However, it is unknown whether daily fluctuation of symptoms or changes in lung function is paralleled by changes in airway inflammation.
Read the detailed description
Patients will undergo a visit every 7 days during one month (5 visits in total). At each visit airway inflammation (exhaled NO, sputum inflammatory cell count) and lung function will be performed. At home patients will be asked to fill a daily diary for symptom assessment.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- COPD treatment
- Keywords
- COPD, Airway inflammation, Symptoms, Lung function, Correlation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPD treatmentOther
Patients, will be asked to continue their previous medication (GOLD guidelines) during the study. No interventional change in COPD treatment will be performed during the study.
| Study group | Role | What they receive |
|---|---|---|
| COPD | Not described Receives: Other: COPD treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between changes in airway inflammation and symptom score
Correlation between changes in airway inflammation and symptom score will be evaluated
Measured: 1 month,
Secondary outcomes (3)
Correlation between changes in airway inflammation and lung function
Correlation between changes in airway inflammation and lung function will be evaluated
Measured: 1 month
Correlations between airway inflammation and symptom scores
Correlation between markers of airway inflammation and symptom score will be performed
Measured: 1 month
Correlations between airway inflammation and lung function
Correlation between markers of airway inflammation and lung function will be assessed
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startJan 2009
- Primary completionJan 2011
- Study completionJul 2011
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Alberto Papi, Università degli Studi di Ferrara
- Investigators
- Alberto Papi, MD, Principal investigator, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216592
- Sponsor's protocol ID
- ISLCOPD01
- Status last verified
- Dec 2011
- First submitted
- 6 Oct 2010
- Last updated
- 6 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Contoli M, Baraldo S, Conti V, Gnesini G, Marku B, Casolari P, Scrigner P, Morelli P, Saetta M, Spanevello A, Papi A. Airway inflammatory profile is correlated with symptoms in stable COPD: A longitudinal proof-of-concept cohort study. Respirology. 2020 Jan;25(1):80-88. doi: 10.1111/resp.13607. Epub 2019 Jun 28.
PubMed 31251440
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlations Between Airway Inflammation, Symptoms and Lung Functions in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01216592
- Acronym / sponsor ID
- ISLCOPD01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Airway inflammation, Symptoms, Lung function, Correlation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 7 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.
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease with high prevalence worldwide and with relevant impact on patient-related quality of life, morbidity and mortality. There is evidence that airway inflammation correlates with the severity of the disease and that airway inflammation is further enhanced during exacerbation. However, it is unknown whether daily fluctuation of symptoms or changes in lung function is paralleled by changes in airway inflammation.
Detailed description
Patients will undergo a visit every 7 days during one month (5 visits in total). At each visit airway inflammation (exhaled NO, sputum inflammatory cell count) and lung function will be performed. At home patients will be asked to fill a daily diary for symptom assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD | – | Other: COPD treatment |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Moderate to severe COPD patients (according to GOLD guidelines) will be enrolled in the study
Key inclusion criteria (3 listed)
- Post-bronchodilator FEV1/FVC ratio < 70%
- Post-bronchodilator FEV1 < 80%
- Smokers or ex-smoker with pack/years > 15
Key exclusion criteria (4 listed)
- Atopy
- Asthma
- Concomitant lung diseases (e.g. lung cancer)
- Acute infections of the respiratory tree in the previous 2 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 |
|---|---|---|
| COPD treatmentPatients, will be asked to continue their previous medication (GOLD guidelines) during the study. No interventional change in COPD treatment will be performed during the study. | Other | COPD |
Primary outcome
Correlation between changes in airway inflammation and symptom score
Time frame: 1 month,
Correlation between changes in airway inflammation and symptom score will be evaluated
3 secondary outcomes
Correlation between changes in airway inflammation and lung function
Time frame: 1 month
Correlations between airway inflammation and symptom scores
Time frame: 1 month
Correlations between airway inflammation and lung function
Time frame: 1 month
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 6 Dec 2011.
- Derived from this study: PubMed 31251440Contoli M, Baraldo S, Conti V, Gnesini G, Marku B, Casolari P, Scrigner P, Morelli P, Saetta M, Spanevello A, Papi A. Airway inflammatory profile is correlated with symptoms in stable COPD: A longitudinal proof-of-concept cohort study. Respirology. 2020 Jan;25(1):80-88. doi: 10.1111/resp.13607. Epub 2019 Jun 28.
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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?
An observational study of 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 3 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 6 Dec 2011. 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?
Correlation between changes in airway inflammation and symptom score (time frame: 1 month,). 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 NCT01216592, 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 6 Dec 2011; AzTrials last refreshed its copy on 30 Oct 2026.