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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02113397

Enrollment

Registered

2014-04-14

Start date

2014-04-30

Completion date

2016-08-31

Last updated

2018-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis, Microbiome, Sputum, Tobramycin, Colistimethate

Brief 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).

Interventions

DRUGTOBI™ Podhaler™ 112 mg inhaled twice daily

DRUGColistimethate 75 mg inhaled two times daily

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Simpson Diversity Index	6 months	The primary estimate in our study is the mean effects of Continuous Alternating Therapy compared to Cyclic therapy on Simpson Diversity Index (SDI) averaged at month 6

Secondary

Measure	Time frame	Description
Bacterial Relative Abundance	6 months	Using 454 pyrosequencing and quantitative polymerase chain reaction (qPCR) techniques, the relative abundance of various bacterial genera will be determined.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026