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Amiloride Solution and Tobramycin Solution for Inhalation for the Eradication of Burkholderia Dolosa in Patients With Cystic Fibrosis

Boston Children's Hospital logo

Boston Children's Hospital

Status and phase

Completed
Phase 1

Conditions

Cystic Fibrosis

Treatments

Drug: Amiloride Solution for Inhalation

Study type

Interventional

Funder types

Other

Identifiers

NCT00547053
06-06-0290

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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