NCT00547053

Brief Summary

The purpose of this research study is to determine if multiple doses of two inhaled drugs will help Cystic Fibrosis patients whose lungs are infected with a bacteria called Burkholderia dolosa. The names of these drugs are tobramycin solution for inhalation and amiloride solution for inhalation. Currently, treating patients with Burkholderia dolosa infections is challenging because the bacteria is resistant to antibiotics. Therefore, researchers are looking for drugs which, when taken with an antibiotic, will help the antibiotic to work more effectively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

May 13, 2011

Status Verified

May 1, 2011

Enrollment Period

1.1 years

First QC Date

October 17, 2007

Last Update Submit

May 12, 2011

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Eradication of Burkholderia dolosa.

    1 month, 3 months, and 6 months

Interventions

Amiloride Solution for InhalationDRUG

4.5 mL, Amiloride Solution for Inhalation, Inhaled via Omron Ultrasonic Nebulizer, TID, 6 months

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Cystic Fibrosis
  • Two positive cultures for Burkholderia dolosa lung infection

You may not qualify if:

  • Positive pregnancy test or currently breast feeding (if applicable)
  • Known sensitivity to Amiloride

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Inhalation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Dawn Ericson, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 17, 2007

First Posted

October 19, 2007

Study Start

December 1, 2006

Primary Completion

January 1, 2008

Study Completion

January 1, 2011

Last Updated

May 13, 2011

Record last verified: 2011-05

Locations

US(1)