Chronic Obstructive Pulmonary DiseaseNCT01305668
Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Emphysema
An observational study of Chronic Obstructive Pulmonary Disease and Emphysema, run by Villa Pineta Hospital at 5 sites in Italy.
Trial summary
Chronic Obstructive Pulmonary Disease has two heterogeneous conditions (chronic bronchitis and pulmonary emphysema phenotypes) with a different clinical presentation. The phenotype evaluation in COPD patient (trough clinical, functional and radiographic parameters) could influence final results in pharmacologic and… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Emphysema
- How many people
- 100 participants
- Where
- 5 sitesItaly
- Study dates
- Aug 2011to Dec 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients with or without Emphysema phenotype
Who may be able to join
- COPD disease with any functional grade
- Adherence to participate to a pulmonary rehabilitation program
Who cannot join
- Recent acute exacerbation (4 weeks preceding enrollment)
- Acute severe concomitant cardiovascular diseases
- Concomitant neoplastic diseases
- NO-Adherence to participate to a pulmonary rehabilitation program
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Italy5 sites
Fondazione Maugeri IRCCS
Lumezzane, Brescia
Clinic Center
Naples
Villa Pineta Hospital
Pavullo nel Frignano, Modena, 41026
Ospedale San Raffaele
Velletri, Roma
Auxilium Vitae Rehabilitation Center
Volterra, Pisa
About this study
Official title: Effectiveness of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Emphysema Phenotype
Chronic Obstructive Pulmonary Disease has two heterogeneous conditions (chronic bronchitis and pulmonary emphysema phenotypes) with a different clinical presentation.
The phenotype evaluation in COPD patient (trough clinical, functional and radiographic parameters) could influence final results in pharmacologic and non-pharmacologic management of the disease.
The aim of our study is to investigate whether COPD patients with different disease phenotype (chronic bronchitis versus pulmonary emphysema) have a different response to PR.
- Conditions
- Chronic Obstructive Pulmonary Disease, Emphysema
- Keywords
- COPD, Emphysema phenotype
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema
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 |
|---|---|---|
| Emphysema phenotype | Not described | |
| No-Emphysema phenotype | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise tolerance
Change in Six minute walked distance (6MWD)
Measured: [Time Frame: Day 1 and 20 ]
Secondary outcomes (4)
Dyspnoea
Change in dyspnea grade by MRC
Measured: [ Time Frame: Day 1 and 20]
Symptoms on effort
Change in Dyspnoea and leg fatigue by Borg scale
Measured: [ Time Frame: Day 1 and 20]
Perceived Quality of life
Change in Saint George Respiratory Questionnarie (Italian version)
Measured: [ Time Frame: Day 1 and 20]
Global function
Change in the multidimensional BODE index (validated in COPD population)
Measured: [ Time Frame: Day 1 and 20]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Villa Pineta Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Clini Enrico, Villa Pineta Hospital
- Investigators
- Enrico M Clini, MD, Study director, Villa Pineta Hospital and University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305668
- Sponsor's protocol ID
- VP-01-2011
- Status last verified
- Dec 2014
- First submitted
- 28 Feb 2011
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease (COPD) Patients With Emphysema Phenotype
- ClinicalTrials.gov ID
- NCT01305668
- Acronym / sponsor ID
- VP-01-2011
- Conditions
- Chronic Obstructive Pulmonary Disease, Emphysema
- Keywords
- COPD, Emphysema phenotype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Villa Pineta HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Mar 2011 (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 has two heterogeneous conditions (chronic bronchitis and pulmonary emphysema phenotypes) with a different clinical presentation.
The phenotype evaluation in COPD patient (trough clinical, functional and radiographic parameters) could influence final results in pharmacologic and non-pharmacologic management of the disease.
The aim of our study is to investigate whether COPD patients with different disease phenotype (chronic bronchitis versus pulmonary emphysema) have a different response to PR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emphysema phenotype | – | – |
| No-Emphysema phenotype | – | – |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients with or without Emphysema phenotype
Key inclusion criteria (2 listed)
- COPD disease with any functional grade
- Adherence to participate to a pulmonary rehabilitation program
Key exclusion criteria (4 listed)
- Recent acute exacerbation (4 weeks preceding enrollment)
- Acute severe concomitant cardiovascular diseases
- Concomitant neoplastic diseases
- NO-Adherence to participate to a pulmonary rehabilitation program
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
Exercise tolerance
Time frame: [Time Frame: Day 1 and 20 ]
Change in Six minute walked distance (6MWD)
4 secondary outcomes
Dyspnoea
Time frame: [ Time Frame: Day 1 and 20]
Symptoms on effort
Time frame: [ Time Frame: Day 1 and 20]
Perceived Quality of life
Time frame: [ Time Frame: Day 1 and 20]
Global function
Time frame: [ Time Frame: Day 1 and 20]
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 10 Dec 2014.
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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.
Enrico M Clini, MD study director
Villa Pineta Hospital and University of Modena and Reggio Emilia
5 sites 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 and Emphysema, run by Villa Pineta Hospital at 5 sites 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 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Exercise tolerance (time frame: [Time Frame: Day 1 and 20 ]). 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 10 Dec 2014; AzTrials last refreshed its copy on 7 Nov 2026.