Ignite Creation Date:
2024-05-06 @ 1:18 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03988816
Status:
UNKNOWN
Last Update Posted:
2020-01-13
First Post:
2019-06-14
Brief Title:
Effect of Roflumilast on Quality of Life Lung Function and Mucus Properties in Patients With Bronchiectasis
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
Effect of Roflumilast on Quality of Life Lung Function and Mucus Properties in Patients With Non-cystic Fibrosis Bronchiectasis a Cross-over Unicentric Double-blind and Placebo-controlled Study
Status:
UNKNOWN
Status Verified Date:
2019-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although relatively common bronchiectasis is considered an orphan disease as there is little evidence for adequate treatment most of the therapeutic options are extrapolated from studies with patients with chronic obstructive pulmonary disease COPD or cystic fibrosis CF Inhaled bronchodilators and corticosteroids should be used as a therapeutic test and maintained if there is improvement of symptoms or lung function There is no evidence to justify the use of mucolytic agents for these patients The treatment with greater evidence is the use of macrolides especially azithromycin A meta-analysis published in 2014 showed that there was a reduction in the number of exacerbations an improvement in the quality of life and a reduction in the decrease in FEV1 However studies have shown conflicting results regarding quality of life and pulmonary function
Roflumilast is a phosphodiesterase-4 inhibitor with an anti-inflammatory effect in vitro and in vivo due to the inhibition of cyclic adenosine monopostat breakdown cAMP to its inactive phosphodiesterase form As this enzyme is expressed in high concentrations in leukocytes and other inflammatory cells responsible for the pathogenesis of pulmonary diseases such as COPD it has been studied and used for this disease COPD is characterized by a chronic inflammatory process of the airways predominantly neutrophils and high levels of proinflammatory cytokines related to this cell such as interleukin-8 neutrophil elastase tumor necrosis factor TNF alpha and E-selectin The REACT study showed that roflumilast prevents moderate and severe infectious exacerbations in addition to improved lung function in patients with COPD who continue to exacerbate despite the use of combined bronchodilator and inhaled corticosteroid therapy
Since bronchiectasis and COPD are chronic inflammatory diseases they present similar inflammatory processes with neutrophil as the main inflammatory cell it is expected that the use of roflumilast also has an anti-inflammatory effect in bronchiectasis In addition since bronchiectasis is a disease with poor evidence for pharmacological treatment it is necessary to search for new therapeutic possibilities
Roflumilast is a phosphodiesterase-4 inhibitor with an anti-inflammatory effect in vitro and in vivo due to the inhibition of cyclic adenosine monopostat breakdown cAMP to its inactive phosphodiesterase form As this enzyme is expressed in high concentrations in leukocytes and other inflammatory cells responsible for the pathogenesis of pulmonary diseases such as COPD it has been studied and used for this disease COPD is characterized by a chronic inflammatory process of the airways predominantly neutrophils and high levels of proinflammatory cytokines related to this cell such as interleukin-8 neutrophil elastase tumor necrosis factor TNF alpha and E-selectin The REACT study showed that roflumilast prevents moderate and severe infectious exacerbations in addition to improved lung function in patients with COPD who continue to exacerbate despite the use of combined bronchodilator and inhaled corticosteroid therapy
Since bronchiectasis and COPD are chronic inflammatory diseases they present similar inflammatory processes with neutrophil as the main inflammatory cell it is expected that the use of roflumilast also has an anti-inflammatory effect in bronchiectasis In addition since bronchiectasis is a disease with poor evidence for pharmacological treatment it is necessary to search for new therapeutic possibilities
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 201817035-5 | OTHER_GRANT | FAPESP | None |