|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
9 October 2023 |
|
Main ID: |
NCT01463371 |
|
Date of registration:
|
28/10/2011 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effects of Azithromycin on Airway Oxidative Stress Markers in Patients With Bronchiectasis
|
|
Scientific title:
|
Effects of Long-Term Azithromycin Treatment on Airway Oxidative Stress Markers in Patients With Stable Non-Cystic Fibrosis Bronchiectasis |
|
Date of first enrolment:
|
October 2006 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT01463371 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Spain
| | | | | | | |
|
Contacts
|
|
Name:
|
Alfredo De Diego Damia, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Instituto Investigación Sanitaria La Fe |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Previous diagnosis of bronchiectasis based on lung HRCT and clinical symptoms
- Clinically stable in previous four weeks without exacerbations
- Informed consent
Exclusion Criteria:
- Bronchiectasis secondary to Cystic fibrosis, pulmonary surgical processes, immune
deficiency, emphysema, allergic bronchopulmonary aspergillosis or diffuse interstitial
pulmonary diseases
- Intolerance to macrolides or severe liver disease.
Age minimum:
16 Years
Age maximum:
80 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Bronchiectasis
|
|
Intervention(s)
|
|
Drug: Azithromycin
|
|
Primary Outcome(s)
|
|
Changes in Nitric oxide,8-isoprostane, pH, nitrites (NO2) and nitrates(NO3) in exhaled breath condensate.
[Time Frame: Before and after three months of treatment]
|
|
Secondary Outcome(s)
|
|
colour and volume sputum,
[Time Frame: Before and after three months of treatment]
|
|
Changes in HRCT Lung scores
[Time Frame: Before and after three months of treatment]
|
|
Impact on functional capacity and health related quality of life
[Time Frame: Before and after three months of treatment]
|
|
changes in lung function
[Time Frame: Before and after three months of treatment]
|
|
Number of Exacerbations
[Time Frame: Before and after three months of treatment]
|
|
Secondary ID(s)
|
|
04/2004/0144
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|