Effect of Azithromycin on Lung Function in 6-18 Year-olds With Cystic Fibrosis (CF) Not Infected With P. Aeruginosa
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 4

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 bacteria's 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,
      and/or making the mucus less sticky, or by affecting the salt channel that doesn't 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.
    

Intervention name(s): azithromycin 250 mg tablets; placebo tablets
Intervention type(s): Drug; Drug
Intervention description(s): One (1) tablet three times weekly for patients who weigh 40-79 lbs
Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs; One (1) tablet three times weekly for patients who weigh 40-79 lbs
Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs
Other intervention name(s): Zithromax; inactive pill
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: azithromycin, Zithromax