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Mannitol Dose Response Study in Cystic Fibrosis

NCT00251056 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2008-08-29

No results posted yet for this study

Summary

Many cystic fibrosis patients die of lung failure caused by repeated lung infections from thick, sticky mucus. Past studies have shown Bronchitol inhalation may help to facilitate the clearance of mucus by altering its rheology and replenishing the airway surface liquid layer in these patients, thereby enhancing the shift of stagnant mucus from the lungs. The study aim is to determine the optimal dose of mannitol to generate clinical improvement in patients with cystic fibrosis.

Conditions

Interventions

DRUG

mannitol

120mg BD

DRUG

mannitol

40 mg BD

DRUG

mannitol

240mg BD

DRUG

mannitol

400mg BD

Sponsors & Collaborators

  • Syntara

    lead INDUSTRY

Principal Investigators

  • Elizabeth Tullis, MD · St Michaels Hospital, Toronto, Ontario, Canada

  • Brett Charlton, MBBS PhD · Pharmaxis Ltd, Sydney, NSW, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Argentina
  • Canada

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 NCT00251056 on ClinicalTrials.gov