NCT02113397

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

March 12, 2018

Status Verified

March 1, 2018

Enrollment Period

2.3 years

First QC Date

April 9, 2014

Last Update Submit

March 8, 2018

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosisMicrobiomeSputumTobramycinColistimethate

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Bacterial Relative Abundance

    6 months

Study Arms (2)

Continuous Therapy

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.

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

Cyclic therapy

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.

Drug: TOBI™ Podhaler™ 112 mg inhaled twice daily

Interventions

TOBI™ Podhaler™ 112 mg inhaled twice dailyDRUG
Also known as: Tobramycin inhalation powder
Continuous TherapyCyclic therapy
Colistimethate 75 mg inhaled two times dailyDRUG
Continuous Therapy

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with cystic fibrosis who are followed at Dartmouth-Hitchcock Medical Center

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Related 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.

    PMID: 22753064BACKGROUND

  • 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.

    PMID: 24451123BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Bacterial genomic DNA will be extracted and purified from sputum samples and sequenced by 454 pyrosequencing.

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

colistinmethanesulfonic acid

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

April 9, 2014

First Posted

April 14, 2014

Study Start

April 1, 2014

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

March 12, 2018

Record last verified: 2018-03

Locations

US(1)