MedTrace Logo

Safety and Efficacy of Bronchitol in Bronchiectasis

NCT00277537 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2008-08-29

No results posted yet for this study

Summary

Study will assess the safety and effectiveness of 12 week treatment with the study medication, Bronchitol, in subjects with bronchiectasis (a lung disease where patients have trapped, and often infected, thick, sticky mucus). Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology (making it less thick and sticky), thereby enhancing the shift of stagnant mucus from the lungs. On completion of the double blind phase, subjects will have the opportunity to participate in a 52 week open label phase.

Conditions

Interventions

DRUG

Mannitol

320mg BD 12 weeks followed by 40 weeks open label

DRUG

placebo

BD for 12 weeks

Sponsors & Collaborators

  • Syntara

    lead INDUSTRY

Principal Investigators

  • Brett Charlton · Pharmaxis Ltd Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Australia
  • New Zealand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00277537 on ClinicalTrials.gov