Ignite Creation Date:
2024-05-06 @ 8:33 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02765295
Status:
UNKNOWN
Last Update Posted:
2019-08-01
First Post:
2016-05-03
Brief Title:
Efficacy and Safety of Hydrogen Inhalation on Bronchiectasis A Randomized Multi-center Double-blind Study
Sponsor:
Guangzhou Institute of Respiratory Disease
Organization:
Guangzhou Institute of Respiratory Disease
Study Overview
Official Title:
Efficacy and Safety of Hydrogen Inhalation on Bronchiectasis HYBRID A Randomized Multi-center Double-blind Parallel-group Study
Status:
UNKNOWN
Status Verified Date:
2019-07
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:
HYBRID
Brief Summary:
This is a multi-center randomized double-blind parallel-group trial After a 2-week run-in period eligible patients will be based on the randomization codes kept in sealed envelopes randomly assigned to receive usual care mucolytics andor chest physiotherapy plus oxygen inahaltion 1 hr daily for 12 consecutive months or hydrogen inhalation 1 hr daily for 12 consecutive months provided by the sponsor At 3 months after the end-of-treatment a follow-up visit will be scheduled for all patients
Detailed Description:
This is a multi-center randomized double-blind parallel-group trial After 2-week run-in period eligible patients will be based on the randomization codes kept in sealed envelopes randomly assigned to two groupsOn the basis of usual care ambroxool 30mg thrice daily or N-acetylcysteine 02g thrice daily serrapeptase 10mg thrice daily or carbocisteine 500mg thrice daily andor chest physiotherapy 10 min twice daily patients were randomized to receive either hydrogen 667 3Lmin 1 hr twice daily inhalation or oxygen inhalation 3Lmin 1 hr twice daily via nasal canula for 12 months A follow-up visit at month 3 following end-of-treatment was also scheduled The primary endpoint was the annual frequency of bronchiectasis exacerbations Hospital visits were scheduled at baseline and months 1 3 6 9 12 and 15 respectively At 3 months after the end-of-treatment a follow-up visit will be scheduled for all patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None