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Mannitol Dose Response Study in Cystic Fibrosis

This study has been completed.
Sponsor:
Information provided by:
Pharmaxis
ClinicalTrials.gov Identifier:
NCT00251056
First received: June 30, 2005
Last updated: August 27, 2008
Last verified: August 2008

June 30, 2005
August 27, 2008
October 2005
August 2008   (final data collection date for primary outcome measure)
  • FEV1 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • FVC [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • FEV1
  • FVC
Complete list of historical versions of study NCT00251056 on ClinicalTrials.gov Archive Site
  • other measures of lung function [ Time Frame: various ] [ Designated as safety issue: No ]
  • QOL [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • sputum microbiology [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • safety [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • sputum clearance and cough [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • respiratory symptoms [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • other measures of lung function
  • QOL
  • sputum microbiology
  • safety
  • sputum clearance and cough
  • respiratory symptoms
Not Provided
Not Provided
 
Mannitol Dose Response Study in Cystic Fibrosis
A Phase IIa Randomised, Open Label, Dose Response Study to Determine the Optimum Dose of Dry Powder Mannitol Required to Generate Clinical Improvement In Patients With Cystic Fibrosis

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Cystic Fibrosis
  • Drug: mannitol
    120mg BD
  • Drug: mannitol
    40 mg BD
  • Drug: mannitol
    240mg BD
  • Drug: mannitol
    400mg BD
  • Active Comparator: 1
    Intervention: Drug: mannitol
  • Active Comparator: 2
    Intervention: Drug: mannitol
  • Active Comparator: 3
    Intervention: Drug: mannitol
  • Active Comparator: 4
    Intervention: Drug: mannitol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
August 2008
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of cystic fibrosis (sweat test/genotype)
  • 7 years or older
  • FEV1 between 40% and 90% of predicted for height, age and gender.
  • Able to perform acceptable-quality spirometry
  • Clinically stable in the week up to study entry
  • No additional antibiotics or additional oral steroids for a period of 14 days before study entry (routine antibiotics permitted)

Exclusion Criteria

  • Currently active asthma
  • Subjects colonized with Burkholderia cepacia or MRSA
  • Considered "terminally ill" or listed for transplantation
  • Requiring home oxygen or assisted ventilation
  • Concurrent illness that in the investigators opinion may contribute to an increased and unacceptable risk if the subject was enrolled in the study (e.g. significant varicies, portal hypertension, cor pulmonale)
  • Significant episode of haemoptysis (>60 mLs) in the previous 12 months
  • Heart attack or stroke in last 3 months
  • Known aortic or cerebral aneurysm
  • Subjects who are breast feeding or pregnant.
  • At risk females unwilling to use appropriate contraception to prevent pregnancy during the course of the study
  • Subjects who have participated in another investigative drug study parallel to, or within 4 weeks of study entry.
  • Known intolerance to mannitol or unable to take any form of bronchodilator medications.
  • Uncontrolled hypertension, systolic BP > 200 or diastolic BP> than 100
  • Concurrent use of beta blocker medication
  • Concurrent use of hypertonic saline

Canada:

  • Concurrent use of other pharmacological mucolytic agents other than Pulmozyme

Argentina:

  • Concurrent use of other pharmacological mucolytic agents including Pulmozyme
Both
7 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Canada
 
NCT00251056
DPM-CF-202
Yes
Brett Charlton, Pharmaxis Ltd
Pharmaxis
Not Provided
Principal Investigator: Elizabeth Tullis, MD St Michaels Hospital, Toronto, Ontario, Canada
Study Director: Brett Charlton, MBBS PhD Pharmaxis Ltd, Sydney, NSW, Australia
Pharmaxis
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP