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Long Term Administration of Inhaled Mannitol in Cystic Fibrosis

NCT00630812 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2020-10-09

Study results available
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Summary

The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. Previous studies have demonstrated improvements in lung function, mucociliary clearance, changes in physical properties of mucus, 24 hour sputum weight and quality of life. The results of this study are to further investigate and confirm these findings in addition to examine the effect on antibiotic use and chest infections. It is hypothesised that inhaled mannitol will have beneficial effects compared to a control treatment. An open label phase of 26 weeks duration will follow the blinded 26 week phase. During the open label phase all subjects will receive active treatment.

Conditions

Interventions

DRUG

inhaled mannitol

400 mg BD for 26 + 26 weeks

DRUG

Placebo comparator

BD for 26 weeks followed by 26 weeks of inhaled mannitol in the open label phase

Sponsors & Collaborators

  • ethica Clinical Research Inc.

    collaborator INDUSTRY

  • Europe: KasaConsult bvba, Hoegaarden, Belgium

    collaborator INDUSTRY

  • Resolution Latin America

    collaborator OTHER

  • Syntara

    lead INDUSTRY

Principal Investigators

  • Moira L Aitken, MD · University of Washington Medical Centre, Seattle WA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-04-30
Completion
2010-11-30

Countries

  • United States
  • Argentina
  • Belgium
  • Canada
  • France
  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

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 NCT00630812 on ClinicalTrials.gov