Evaluation of Inhaled Antibiotics on Bacterial Diversity and Richness in the Cystic Fibrosis Lung
| Status: | Terminated |
|---|---|
| Conditions: | Pulmonary, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 12 - 75 |
| Updated: | 4/17/2018 |
| Start Date: | April 2014 |
| End Date: | August 2016 |
Comparative Evaluation of Bacterial Diversity and Richness in CF Lung in Patients Who Use Cycled Every Other Month Tobramycin Inhalation Powder (TOBI™ Podhaler™) Or Continuous Alternating Therapy With Tobramycin Inhalation Powder (TOBI™ Podhaler™) and Inhaled Colistimethate
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).
of cystic fibrosis patients treated with every-other-month TOBI™ Podhaler™ and continuous
alternating therapy with TOBI™ Podhaler and colistimethate (Colistin).
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
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