Evaluation of Inhaled Antibiotics on Bacterial Diversity and Richness in the Cystic Fibrosis Lung

• Status: Terminated
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to characterize bacterial diversity and richness in the sputum of cystic fibrosis patients treated with every-other-month TOBI™ Podhaler™ and continuous alternating therapy with TOBI™ Podhaler and colistimethate (Colistin).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborator: Novartis Pharmaceuticals
• Treatments: Colistin; Tobramycin

Criteria

Inclusion Criteria:

• Diagnosis of cystic fibrosis confirmed by mutation analysis of the cystic fibrosis transmembrane conductance regulator gene

• Sputum or throat swab culture positive for Pseudomonas aeruginosa at or within 6 months of enrollment

• Age ≥12 years

• Forced expiratory volume in one second (FEV1) 25-90 percent-predicted

Exclusion Criteria:

• Age <18 years

• Inability to routinely expectorate sputum without induction by hypertonic saline

• Inability to provide or withdrawal of written informed consent

• History of aminoglycoside sensitivity or adverse reaction to inhaled antibiotics

• Serum creatinine ≥ 2.0 mg/dl

• Serum blood urea nitrogen (BUN) ≥40 mg/dl

• Pregnancy or lactating at screening

• History of systemic intravenous anti-Pseudomonal antibiotics within 28 days of enrollment