EmphysemaNCT02008162
Bronchoreversibility and Radiologic Morphology of Emphysema
An observational study of Emphysema and COPD, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
To assess response to bronchodilation with tiotropium plus salbutamol in patients with severe emphysema and analyze relationships between bronchoreversibility response and semiquantitative computed-tomography based emphysema severity measures. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- What is being tested?
- Bronchodilators
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2009to Dec 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe heterogeneous emphysema selected as potential candidtes for lung volume reduction surgery
Who may be able to join
- Radiologic evidence of severe heterogeneous emphysema
- GOLD COPD class III-IV
- No other significant pulmonary comorbidity
- Quit smoking since at least 4 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Tor Vergata
Rome, 00133
Eugenio Pompeo, MD, +393496154524, pompeo@med.uniroma2.it
Eugenio Pompeo, MD
About this study
Official title: Response to Bronchodilation With Tiotropium Plus Salbutamol Correlates With Radiologic Morphology of the Lung in COPD of the Emphysematous Phenotype
To assess response to bronchodilation with tiotropium plus salbutamol in patients with severe emphysema and analyze relationships between bronchoreversibility response and semiquantitative computed-tomography based emphysema severity measures.
- Being tested
- Bronchodilators
- Keywords
- Emphysema, COPD, bronchoreversibility, ventilatory obstruction, lung volume reduction surgery, LVRS
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchodilatorsDrug
Also called Albuterol, Tiotropium bromide
Administration of both albuterol and tiotropium bromide after a 48h period of washout from all bronchodilators, followed by spirometry and plethysmography
| Study group | Role | What they receive |
|---|---|---|
| Bronchodilators | Patients with severe heterogeneous emphysema selected as potential candidtes for lung volume reduction surgery.
Bronchodilators employed for the study include albuterol 200µg and tiotropium bromide 18 µg administered by puffs following a first spirometry and plethysmography performed after a washout period of 48h from all bronchodilators and subsequently repeated within 30 min after bronchodilators administration. Receives: Drug: Bronchodilators |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-bronchodilator FEV1 change
Assessed by spirometry carried out before and after administration of bronchodilators
Measured: 1 h
post-bronchodilator change in FVC
Assessed by spirometry carried out before and after administration of bronchodilators
Measured: 1h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startNov 2009
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmphysemaStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugenio Pompeo, University of Rome Tor Vergata
- Investigators
- Eugenio Pompeo, MD, Principal investigator, Tor Vergata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008162
- Sponsor's protocol ID
- BREPTV-108.7
- Status last verified
- Dec 2013
- First submitted
- 6 Dec 2013
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to Bronchodilation With Tiotropium Plus Salbutamol Correlates With Radiologic Morphology of the Lung in COPD of the Emphysematous Phenotype
- ClinicalTrials.gov ID
- NCT02008162
- Acronym / sponsor ID
- BREPTV-108.7
- Keywords
- Emphysema, COPD, bronchoreversibility, ventilatory obstruction, lung volume reduction surgery, LVRS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2013 (actual)
- First posted
- 11 Dec 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.
To assess response to bronchodilation with tiotropium plus salbutamol in patients with severe emphysema and analyze relationships between bronchoreversibility response and semiquantitative computed-tomography based emphysema severity measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bronchodilators | – | Drug: BronchodilatorsPatients with severe heterogeneous emphysema selected as potential candidtes for lung volume reduction surgery. Bronchodilators employed for the study include albuterol 200µg and tiotropium bromide 18 µg administered by puffs following a first spirometry and plethysmography performed after a washout period of 48h from all bronchodilators and subsequently repeated within 30 min after bronchodilators administration. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe heterogeneous emphysema selected as potential candidtes for lung volume reduction surgery
Key inclusion criteria (4 listed)
- Radiologic evidence of severe heterogeneous emphysema
- GOLD COPD class III-IV
- No other significant pulmonary comorbidity
- Quit smoking since at least 4 months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| BronchodilatorsAlso: Albuterol, Tiotropium bromideAdministration of both albuterol and tiotropium bromide after a 48h period of washout from all bronchodilators, followed by spirometry and plethysmography | Drug | Bronchodilators |
Primary outcome
post-bronchodilator FEV1 change
Time frame: 1 h
Assessed by spirometry carried out before and after administration of bronchodilators
post-bronchodilator change in FVC
Time frame: 1h
Assessed by spirometry carried out before and after administration of bronchodilators
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 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.
Eugenio Pompeo, MD principal investigator
Tor Vergata University
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 Emphysema and COPD, run by University of Rome Tor Vergata 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 4 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 11 Dec 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-bronchodilator FEV1 change (time frame: 1 h). The study lists 2 primary outcomes in all. 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 11 Dec 2013.