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

Dartmouth Health

Status: Terminated

Conditions: Cystic Fibrosis

Treatments: Drug: TOBI™ Podhaler™ 112 mg inhaled twice daily; Drug: Colistimethate 75 mg inhaled two times daily

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02113397

D14010

CTBM100DUS02T (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Enrollment: 1 patient

Sex: All

Ages: 12 to 75 years old

Volunteers: No 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

Trial design

1 participants in 2 patient groups

Continuous Therapy

Description:

TOBI™ Podhaler™ 112 mg inhaled by mouth twice daily for 30 days followed by a 30-day cycle colistimethate 75 mg inhaled two times daily. Repeat cycle.

Treatment:

Drug: TOBI™ Podhaler™ 112 mg inhaled twice daily

Drug: Colistimethate 75 mg inhaled two times daily

Cyclic therapy

Description:

TOBI™ Podhaler™ 112 mg inhaled by mouth twice daily for 30 days followed by a 30-day period during which no inhaled antibiotics are used. Repeat cycle.

Treatment:

Drug: TOBI™ Podhaler™ 112 mg inhaled twice daily