A three year follow up study to assess the rate of death and other diseases in patients with a long-term condition where the airways of the lungs become widened, leading to a build-up of excess mucus that can make the lungs more vulnerable to infection (bronchiectasis)
| ISRCTN | ISRCTN11243396 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11243396 |
| Secondary identifying numbers | RBR 61923316.1.0000.5259 |
- Submission date
- 15/11/2021
- Registration date
- 23/11/2021
- Last edited
- 08/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Bronchiectasis is a long-term condition where the airways of the lungs become widened, leading to a build-up of excess mucus that can make the lungs more vulnerable to infection. The most common symptoms of bronchiectasis include a persistent cough that usually brings up phlegm (sputum) shortness of breath.
This study aims to investigate the long-term risk factors and health outcomes for patients with bronchiectasis, over 3 years.
Who can participate?
Patients with bronchiectasis.
What does the study involve?
Participants complete a number of tests and questionnaires at the initial consultation and the patients are monitored over the next 3 years.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Pedro Ernesto University Hospital (Brazil)
When is the study starting and how long is it expected to run for?
March 2016 to December 2024
Who is funding the study?
FAPERJ (Research Support Foundation of the State of Rio de Janeiro) (Brazil)
Who is the main contact?
Prof. Rogério Rufino, rrufino.uerj@gmail.com
Contact information
Public
Avenida 28 de Setembro, 77 - second floor - Pulmonology Service
Rio de Janeiro
20551030
Brazil
 ORCID ID |
0000-0002-5071-6045 |
|---|---|
| Phone | +55.21.986255240 |
| rrufino.uerj@gmail.com |
Study information
| Study design | Prospective observational single-center cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Mortality and comorbidities in patients with bronchiectasis over a three-year follow-up |
| Study objectives | Bronchiectasia has high mortality despite treatment |
| Ethics approval(s) | Approved 17/11/2016, Research Ethics Committee of the Pedro Ernesto University Hospital (CePeM – Centro de Pesquisa Clínica Multiusuário – 2nd floor /room 28, Pedro Ernesto University Hospital, Rio de Janeiro, Brazil; +55. 21 2868-8253; cep@hupe.uerj.br), ref: 1,823,665 |
| Health condition(s) or problem(s) studied | Risk factors for mortality in patients with non-cystic fibrosis bronchiectasis |
| Intervention | Prospective cohort study comprising 120 adult patients with non-cystic fibrosis bronchiectasis regularly treated at the specialized outpatient clinic of a university hospital between January 2017 and June 2020. All patients had the diagnosis confirmed by high-resolution computed tomography. Demographic and clinical data, pulmonary function test, and Euro quality-of-life five-domain three-level questionnaire (EQ-5D-3L) were analyzed. Factors associated with death were determined using the Cox proportional hazard model. |
| Intervention type | Behavioural |
| Primary outcome measure | Mortality measured using patient records at the end of the study |
| Secondary outcome measures | Quality of life measured using Euro quality-of-life five-domain three-level questionnaire (EQ-5D-3L) at the initial consultation |
| Overall study start date | 17/03/2016 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 100 |
| Key inclusion criteria | Diagnosis of bronchiectasis confirmed by chest HRCT, evaluated by two radiologists and two pulmonologists |
| Key exclusion criteria | Cystic fibrosis |
| Date of first enrolment | 01/02/2017 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Rio de Janeiro
20551030
Brazil
Sponsor information
Research organisation
Edifício Estado de Sá - 6º Andar
Av. Erasmo Braga, 118 - Centro
Rio de Janeiro
20020-000
Brazil
| Phone | +55.21.2333-2000 |
|---|---|
| central.atendimento@faperj.br | |
| Website | http://www.faperj.br/ |
"ROR" |
https://ror.org/03kk0s825 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Published as a supplement to the results publication |
| Publication and dissemination plan | BMC Pulmonary Medicine |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request (rrufino.uerj@gmail.com) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | 1-year quality of life results | 01/03/2022 | 15/07/2022 | Yes | No |
Editorial Notes
08/10/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/05/2017 to 31/12/2024.
2. The overall end date was changed from 30/06/2020 to 31/12/2024.
15/07/2022: Publication reference added.
23/11/2021: Trial's existence confirmed by Research Ethics Committee of the Pedro Ernesto University Hospital.
