BronchiectasisNCT01268475
Exercise Capacity in Bronchiectasis Resection
An observational study of Bronchiectasis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Bronchiectasis can be defined as an abnormal and irreversible dilatation of the bronchial tree due to repeated cycles of inflammation and infection, resulting in progressive loss of lung function. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bronchiectasis
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to not given
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinical and radiological diagnosis of bronchiectasis recruited on Pulmonary Suppurative Disease Clinic of Thoracic Surgery Department
Who may be able to join
- Clinical and radiographic diagnosis of bronchiectasis;
- Lack of adequate response to clinical treatment after 1 year of follow-up and / or presence of disease complications;
- Agreement to participate of the study by signing of the Informed Consent Term
Who cannot join
- Comorbidities that prevent the patient to undergo general anesthesia;
- Musculoskeletal and/or psychomotor disability to perform pulmonary function tests and cardiopulmonary exercise tests;
- Inability to understand the quality of life questionnaires;
- Age over 90 years or less 18 years.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo Medical School - Heart Institute
São Paulo, São Paulo, 05403-000
Ricardo Mingarini Terra, MD, PhD, 55 11 30695197, rmterra@uol.com.br
Ricardo M Terra, MD, PhD
About this study
Official title: Impact of Pulmonary Resection on Exercise Capacity in Patients With Bronchiectasis
Bronchiectasis can be defined as an abnormal and irreversible dilatation of the bronchial tree due to repeated cycles of inflammation and infection, resulting in progressive loss of lung function. The surgical treatment by pulmonary resection or even lung transplantation is indicated in cases of bronchiectasis primary nonresponsive to appropriate medical treatment, or when associated with serious complications. There are few literature data on the influence of bronchiectasis in exercise capacity, quality of life and functional capacity, and the impact of lung resection in patients with this diagnosis. The primary objective of this study is to evaluate prospectively the impact of lung resection on exercise capacity in patients with clinical and radiological diagnosis of bronchiectasis. The secondary objective of this study is to evaluate the impact of lung resection on quality of life and lung function and to analyze the the presence of predictors of postoperative functional deterioration and the occurrence of complications.
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis, Quality of Life, Respiratory Function Tests, Exercise Test
- Medical subject headings
- Bronchiectasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Pulmonary Resection on Exercise Capacity
Exercise Capacity will be assessed using Cardiopulmonary Exercise Test.
Measured: Change from Baseline in Exercise Capacity at 3 months and Change from Baseline in Exercise Capacity at 9 months
Secondary outcomes (2)
Impact of Pulmonary Resection on Quality of Life.
Quality of life will be assessed using WHOQOL-Bref and SF-36 questionnaries.
Measured: Change from Baseline in Quality of Life at 3 months and Change from Baseline in Quality of Life at 9 months.
Impact of Pulmonary Resection on Lung Function.
Lung Function will be assessed using Spirometry Test.
Measured: Change from Baseline in Lung Function at 3 months and Change from Baseline in Lung Function at 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2010 (estimated)
- Study startMar 2009
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 BronchiectasisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268475
- Sponsor's protocol ID
- CAPPesq 0671/10
- Status last verified
- Nov 2010
- First submitted
- 18 Nov 2010
- Last updated
- 30 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mariani AW, Vallilo CC, de Albuquerque ALP, Salge JM, Augusto MC, Suesada MM, Pego-Fernandes PM, Terra RM. Preoperative evaluation for lung resection in patients with bronchiectasis: should we rely on standard lung function evaluation? Eur J Cardiothorac Surg. 2021 Jun 14;59(6):1272-1278. doi: 10.1093/ejcts/ezaa454.
PubMed 33491053
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Pulmonary Resection on Exercise Capacity in Patients With Bronchiectasis
- ClinicalTrials.gov ID
- NCT01268475
- Acronym / sponsor ID
- CAPPesq 0671/10
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis, Quality of Life, Respiratory Function Tests, Exercise Test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Mar 2009
- First posted
- 30 Dec 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.
Bronchiectasis can be defined as an abnormal and irreversible dilatation of the bronchial tree due to repeated cycles of inflammation and infection, resulting in progressive loss of lung function. The surgical treatment by pulmonary resection or even lung transplantation is indicated in cases of bronchiectasis primary nonresponsive to appropriate medical treatment, or when associated with serious complications. There are few literature data on the influence of bronchiectasis in exercise capacity, quality of life and functional capacity, and the impact of lung resection in patients with this diagnosis. The primary objective of this study is to evaluate prospectively the impact of lung resection on exercise capacity in patients with clinical and radiological diagnosis of bronchiectasis. The secondary objective of this study is to evaluate the impact of lung resection on quality of life and lung function and to analyze the the presence of predictors of postoperative functional deterioration and the occurrence of complications.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical and radiological diagnosis of bronchiectasis recruited on Pulmonary Suppurative Disease Clinic of Thoracic Surgery Department
Key inclusion criteria (3 listed)
- Clinical and radiographic diagnosis of bronchiectasis;
- Lack of adequate response to clinical treatment after 1 year of follow-up and / or presence of disease complications;
- Agreement to participate of the study by signing of the Informed Consent Term
Key exclusion criteria (4 listed)
- Comorbidities that prevent the patient to undergo general anesthesia;
- Musculoskeletal and/or psychomotor disability to perform pulmonary function tests and cardiopulmonary exercise tests;
- Inability to understand the quality of life questionnaires;
- Age over 90 years or less 18 years.
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
Impact of Pulmonary Resection on Exercise Capacity
Time frame: Change from Baseline in Exercise Capacity at 3 months and Change from Baseline in Exercise Capacity at 9 months
Exercise Capacity will be assessed using Cardiopulmonary Exercise Test.
2 secondary outcomes
Impact of Pulmonary Resection on Quality of Life.
Time frame: Change from Baseline in Quality of Life at 3 months and Change from Baseline in Quality of Life at 9 months.
Impact of Pulmonary Resection on Lung Function.
Time frame: Change from Baseline in Lung Function at 3 months and Change from Baseline in Lung Function at 9 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2010.
- Derived from this study: PubMed 33491053Mariani AW, Vallilo CC, de Albuquerque ALP, Salge JM, Augusto MC, Suesada MM, Pego-Fernandes PM, Terra RM. Preoperative evaluation for lung resection in patients with bronchiectasis: should we rely on standard lung function evaluation? Eur J Cardiothorac Surg. 2021 Jun 14;59(6):1272-1278. doi: 10.1093/ejcts/ezaa454.
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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.
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 Bronchiectasis, run by University of Sao Paulo at 1 site in Brazil.
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: status not confirmed, as of the sponsor's last update on 30 Dec 2010. 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 Brazil. 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?
Contact Ricardo Mingarini Terra, MD, PhD (55 11 3069597, rmterra@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Pulmonary Resection on Exercise Capacity (time frame: Change from Baseline in Exercise Capacity at 3 months and Change from Baseline in Exercise Capacity at 9 months). 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 NCT01268475, 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 30 Dec 2010.