Trial Information

Summary: Multi-Center, Multi-National, Randomized, Placebo-Controlled Trial of Azithromycin in Subjects with Cystic Fibrosis 6-18 years old, Culture Negative for Pseudomonas aeruginosa (AZ0004)

The primary purpose of this study is to determine effect of 24 weeks of three times weekly administration of azithromycin as compared to placebo on pulmonary function in CF subjects who are culture negative for P. aeruginos.

Secondary objectives are to determine the safety of 24 weeks of three times weekly administration of azithromycin as compared to placebo, to determine the effect of 24 weeks of three times weekly administration of azithromycin as compared to placebo on exacerbation parameters, weight, height, microbiology, and inflammatory markers, and during the 24 week open label, follow-on study, to determine the long term safety, tolerability, and durability of response to azithromycin among subjects continuing on azithromycin after the randomized portion of the trial and among placebo subjects switching over to azithromycin after the randomized trial.

Patient Inclusion Criteria:

• Male and female 6-18 years of age at enrollment.
• Confirmed diagnosis of cystic fibrosis by one or more clinical features consistent with the CF phenotype and documented sweat chloride >60 mEq/L (by pilocarpine iontophoresis test), or a genotype with tow identifiable mutations consistent with CF.
• Provide written informed consent, HIPAA authorization (where applicable), and
• assent (as appropriate) prior to the performance of any study-related procedure.
• Clinically stable at enrollment as assessed by the site investigator.
• Respiratory cultures negative for P aeruginosa for one year or longer at the time of screening as defined as at least two consecutive respiratory cultures negative for P aeruginosa which could include the negative screening culture as one of the two consecutive cultures. (Respiratory culture can be sputum, bronchial wash, or oropharyngeal swab for non-sputum producers).
• FEV1 predicted ¡Ý 50% as calculated by the Wang reference equations (refer to study manual)
• Able to comply with all protocol requirements.
• Ability to swallow a 250mg tablet.

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Trial listings updated: June 1, 2008 at 6:42:54 AM