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

Cystic Fibrosis Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02113397
• Other study ID #: D14010
• Secondary ID: CTBM100DUS02T
• Status: Terminated
• Phase: N/A
• First received: April 9, 2014
• Last updated: March 8, 2018
• Start date: April 2014
• Est. completion date: August 2016

Study information

• Verified date: March 2018
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• TOBI™ Podhaler™ 112 mg inhaled twice daily

• Colistimethate 75 mg inhaled two times daily

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (2)

Filkins LM, Hampton TH, Gifford AH, Gross MJ, Hogan DA, Sogin ML, Morrison HG, Paster BJ, O'Toole GA. Prevalence of streptococci and increased polymicrobial diversity associated with cystic fibrosis patient stability. J Bacteriol. 2012 Sep;194(17):4709-17. doi: 10.1128/JB.00566-12. Epub 2012 Jun 29. — View Citation

Price KE, Hampton TH, Gifford AH, Dolben EL, Hogan DA, Morrison HG, Sogin ML, O'Toole GA. Unique microbial communities persist in individual cystic fibrosis patients throughout a clinical exacerbation. Microbiome. 2013 Nov 1;1(1):27. doi: 10.1186/2049-2618-1-27. — View Citation

Outcome

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