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Completed

NCT Number: NCT00547053

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

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Children's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amiloride Solution for Inhalation

Drug

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

Primary outcomes

  1. Eradication of Burkholderia dolosa.

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

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Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Official study title

A Six Month Open Label Study of Amiloride Solution for Inhalation and Tobramycin Solution for Inhalation for the Eradication of Burkholderia Dolosa in Patients With Cystic Fibrosis

Important dates

Study start
2006
Primary completion
2008
Study completion
2011
First posted
Oct 19, 2007
Registry last updated
May 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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