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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02113397
• Date of registration: 09/04/2014
• Prospective Registration: No
• Primary sponsor: Dartmouth-Hitchcock Medical Center
• Public title: Evaluation of Inhaled Antibiotics on Bacterial Diversity and Richness in the Cystic Fibrosis Lung
• Scientific title: 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
• Date of first enrolment: April 2014
• Target sample size: 1
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02113397
• Study type: Observational

Countries of recruitment

United States

Key inclusion & exclusion 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



Age minimum: 12 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: TOBI™ Podhaler™ 112 mg inhaled twice daily

Drug: Colistimethate 75 mg inhaled two times daily

Primary Outcome(s)

Simpson Diversity Index [Time Frame: 6 months]

Secondary Outcome(s)

Bacterial Relative Abundance [Time Frame: 6 months]

Secondary ID(s)

CTBM100DUS02T

D14010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novartis Pharmaceuticals