Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06160713
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-11-29
Brief Title:
Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations
Sponsor:
Post Graduate Institute of Medical Education and Research Chandigarh
Organization:
PGIMER
Study Overview
Official Title:
A Randomized Controlled Trial to Compare Oral Itraconazole and Standard Care Versus Standard Care Alone in Patients With Non-cystic Fibrosis Related Bronchiectasis With Chronic Aspergillus Infection in Reducing Bronchiectasis Exacerbations
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
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:
BAIT
Brief Summary:
There is an intricate link between bronchiectasis and fungi Patients with cystic fibrosis frequently manifest fungal sensitization and fungal colonization with Aspergillus fumigatus6 Aspergillus species also has a cause-and-effect relationship with non-CF cystic fibrosis bronchiectasis7 8 In allergic bronchopulmonary aspergillosis ABPA Aspergillus is the cause of bronchiectasis In contrast in other causes of bronchiectasis A fumigatus can theoretically promote allergic response which may result in poor lung function increase the risk of exacerbations and even cause ABPA over time9 10 In a recent study we found an overall prevalence of Aspergillus sensitization of 295 and the prevalence of chronic aspergillus infection was 7611 The prevalence of chronic aspergillus colonization in non-tuberculosis TB-non-CF fibrosis was 475 4910311 By mechanism similar to chronic bacterial colonization chronic aspergillus infection or aspergillus sensitization can increase the risk of bronchiectasis exacerbation Therefore eradication of A fumigatus from the airways of patients with bronchiectasis would decrease the future risk of a bronchiectasis exacerbation Notably in ABPA use of itraconazole and voriconazole reduce the exacerbations by reducing the fungal burden in the airways12 13 In this randomized trial we will investigate whether treatment with oral itraconazole for six months would reduce the future risk of bronchiectasis exacerbation in patients with non-CF-non-ABPA bronchiectasis
Detailed Description:
Bronchiectasis is a chronic lung disease due to irreversible and abnormal dilatation of the bronchi Bronchiectasis manifest with chronic cough expectoration hemoptysis dyspnea and others Bronchiectasis can be broadly classified as genetic cystic fibrosis CF ciliary dyskinesia and others or acquired post-infective tuberculosis TB allergic bronchopulmonary aspergillosis ABPA and others1 The natural course of bronchiectasis is associated with recurrent exacerbations that cause further damage and disease progression2 Most exacerbations are caused by viral or bacterial infections inflammation and external environment factors Chronic bacterial infections increase the risk of bronchiectasis exacerbation2 In a multicentric European study chronic infection with Pseudomonas aeruginosa was associated with an increased risk of exacerbation3 Notably change in the interaction between the bacterial microbiome by external inciting events viral infection or air pollution increases exacerbation risk4 Similarly viral infections by increasing the systemic and airway inflammation induce a bronchiectasis exacerbation5 Airway inflammation both neutrophilic and eosinophilic are also important causes of bronchiectasis exacerbations2 Most previous studies in non-CF bronchiectasis have not investigated the role of fungal sensitization or chronic fungal infection in causing bronchiectasis exacerbation
There is an intricate link between bronchiectasis and fungi Patients with cystic fibrosis frequently manifest fungal sensitization and fungal colonization with Aspergillus fumigatus6 Aspergillus species also has a cause-and-effect relationship with non-CF bronchiectasis7 8 In ABPA Aspergillus is the cause of bronchiectasis In contrast in other causes of bronchiectasis A fumigatus can theoretically promote allergic response which may result in poor lung function increase the risk of exacerbations and even cause ABPA over time9 10 In a recent study we found an overall prevalence of Aspergillus sensitization of 295 and the prevalence of chronic aspergillus infection was 7611 The prevalence of chronic aspergillus colonization in non-TB-non-CF fibrosis was 475 4910311 By mechanism similar to chronic bacterial colonization chronic aspergillus infection or aspergillus sensitization can increase the risk of bronchiectasis exacerbation Therefore eradication of A fumigatus from the airways of patients with bronchiectasis would decrease the future risk of a bronchiectasis exacerbation Notably in ABPA use of itraconazole and voriconazole reduce the exacerbations by reducing the fungal burden in the airways12 13 In this randomized trial we will investigate whether treatment with oral itraconazole for six months would reduce the future risk of bronchiectasis exacerbation in patients with non-CF-non-ABPA bronchiectasis
Study question Does oral itraconazole for six months reduce the bronchiectasis exacerbation in patients with non-cystic fibrosis bronchiectasis
There is an intricate link between bronchiectasis and fungi Patients with cystic fibrosis frequently manifest fungal sensitization and fungal colonization with Aspergillus fumigatus6 Aspergillus species also has a cause-and-effect relationship with non-CF bronchiectasis7 8 In ABPA Aspergillus is the cause of bronchiectasis In contrast in other causes of bronchiectasis A fumigatus can theoretically promote allergic response which may result in poor lung function increase the risk of exacerbations and even cause ABPA over time9 10 In a recent study we found an overall prevalence of Aspergillus sensitization of 295 and the prevalence of chronic aspergillus infection was 7611 The prevalence of chronic aspergillus colonization in non-TB-non-CF fibrosis was 475 4910311 By mechanism similar to chronic bacterial colonization chronic aspergillus infection or aspergillus sensitization can increase the risk of bronchiectasis exacerbation Therefore eradication of A fumigatus from the airways of patients with bronchiectasis would decrease the future risk of a bronchiectasis exacerbation Notably in ABPA use of itraconazole and voriconazole reduce the exacerbations by reducing the fungal burden in the airways12 13 In this randomized trial we will investigate whether treatment with oral itraconazole for six months would reduce the future risk of bronchiectasis exacerbation in patients with non-CF-non-ABPA bronchiectasis
Study question Does oral itraconazole for six months reduce the bronchiectasis exacerbation in patients with non-cystic fibrosis bronchiectasis
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