Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00431964
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2007-02-02
Brief Title:
Effect of Azithromycin on Lung Function in 6-18 Year-olds With Cystic Fibrosis CF Not Infected With P Aeruginosa
Sponsor:
CF Therapeutics Development Network Coordinating Center
Organization:
CF Therapeutics Development Network Coordinating Center
Study Overview
Official Title:
Multi-center Multi-national Randomized Placebo-Controlled Trial of Azithromycin in Subjects With Cystic Fibrosis 6-18 Years Old Culture Negative for Pseudomonas Aeruginosa
Status:
COMPLETED
Status Verified Date:
2015-07
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:
None
Brief Summary:
This is a study to examine the safety effect on lung function and frequency of symptoms relating to cystic fibrosis during 24 weeks of treatment with the antibiotic azithromycin in 6-18 year-olds with CF who are not infected with Pseudomonas aeruginosa
Detailed Description:
Azithromycin is an antibiotic that has been shown to improve lung function in patients with cystic fibrosis CF whose lungs are infected with a bacterium called Pseudomonas aeruginosa Scientists are not sure how azithromycin works in cystic fibrosis It does not appear to work by killing the bacteria Pseudomonas aeruginosa but it may make these bacteria and other bacteria less damaging to the lungs by reducing their ability to attach to the lining of the lung or by reducing the bacterias ability to make substances that damage the lungs of patients with cystic fibrosis Azithromycin may also work directly on the cells in the lungs to improve lung function This could occur by reducing inflammation swelling in the lungs andor making the mucus less sticky or by affecting the salt channel that doesnt function correctly in CF If azithromycin works in one or more of these ways it may also be effective in improving lung function in cystic fibrosis patients who are not infected with Pseudomonas aeruginosa
We are conducting this research study to examine the safety effect on lung function and frequency of symptoms relating to cystic fibrosis during 24 weeks of treatment with the antibiotic azithromycin This study is designed to determine if patients with cystic fibrosis whose lungs are not infected with the bacteria Pseudomonas aeruginosa will benefit from 24 weeks of treatment with the antibiotic azithromycin Benefit will be determined as having better pulmonary function tests and getting sick less often compared to a placebo sugar pill This study is also designed to determine if azithromycin is safe when administered for 24 weeks to cystic fibrosis patients not infected with Pseudomonas aeruginosa By doing this study we hope to learn more about CF and improve the way in which we treat it
Comparison Three times weekly azithromycin tablets added to standard care compared to three times weekly placebo tablets added to standard care
We are conducting this research study to examine the safety effect on lung function and frequency of symptoms relating to cystic fibrosis during 24 weeks of treatment with the antibiotic azithromycin This study is designed to determine if patients with cystic fibrosis whose lungs are not infected with the bacteria Pseudomonas aeruginosa will benefit from 24 weeks of treatment with the antibiotic azithromycin Benefit will be determined as having better pulmonary function tests and getting sick less often compared to a placebo sugar pill This study is also designed to determine if azithromycin is safe when administered for 24 weeks to cystic fibrosis patients not infected with Pseudomonas aeruginosa By doing this study we hope to learn more about CF and improve the way in which we treat it
Comparison Three times weekly azithromycin tablets added to standard care compared to three times weekly placebo tablets added to standard care
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