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

Boston Children's Hospital25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

Amiloride Solution for Inhalation

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

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Eradication of Burkholderia dolosa.

Time frame: 1 month, 3 months, and 6 months

Data from ClinicalTrials.gov

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