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A Phase 2 Study to Determine the Safety and Efficacy of Inhaled Dry Powder Mannitol in Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00455130
Recruitment Status : Completed
First Posted : April 3, 2007
Last Update Posted : February 2, 2010
Information provided by:

Tracking Information
First Submitted Date  ICMJE April 2, 2007
First Posted Date  ICMJE April 3, 2007
Last Update Posted Date February 2, 2010
Study Start Date  ICMJE March 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2007)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2007)
  • Other measures of lung function
  • Quality of life
  • Sputum microbiology
  • Sputum rheology
  • Safety
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Phase 2 Study to Determine the Safety and Efficacy of Inhaled Dry Powder Mannitol in Cystic Fibrosis
Official Title  ICMJE Not Provided
Brief Summary

Cystic fibrosis is the most frequent lethal genetic disease of childhood. Causes disruption of glandular function of the pancreas, intestine, liver, lungs (causing chronic lung infection with emphysema), sweat glands and reproductive organs. We know that many CF patients die of lung failure, brought about in part by repeated lung infections caused by thick, sticky mucus that cannot be readily cleared from the lung.

Inhaled mannitol is an osmotic agent that has been investigated in a number of small studies that have examined mucociliary clearance, quality of life and lung function in CF and bronchiectasis. The promising results of these studies warrant futher investigation. The aim of this study is to assess the safety and efficacy of inhaled mannitol when administered twice a day over two weeks in CF.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE Drug: Inhaled mannitol
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Confirmed diagnosis of cystic fibrosis (sweat test/genotype)
  2. Aged 8 years or older
  3. Have FEV1 between 40% and 80% of predicted for height, age and gender OR a decrease in FEV1 of 20% or more than that recorded 6-12 months previously.
  4. As determined by the investigator, are capable and willing to

    • Use the study diary as required for this protocol
    • Able to perform all of the techniques necessary to measure lung function
    • Able to administer the dry powder mannitol
  5. Are capable of and have given informed consent
  6. Clinically stable at study entry

Exclusion Criteria:

  1. Investigators, site personnel directly affiliated with this study, and their immediate families.
  2. Subjects under the age of 8 years.
  3. Subjects with currently active asthma
  4. Subjects using hypertonic saline treatment in the last 2 weeks
  5. Considered "terminally ill" or listed for transplantation
  6. Requiring home oxygen or assisted ventilation
  7. Colonisation with Burkholderia cepacia
  8. Significant episode of hemoptysis (>60 mls) in the previous 12 months
  9. Myocardial Infarction in the six months prior to enrolment.
  10. Cerebral Vascular Accident in the six months prior to enrolment.
  11. Ocular surgery in the three months prior to enrolment.
  12. Abdominal surgery in the three months prior to enrolment.
  13. Subjects who are breast feeding or pregnant.
  14. Female subjects of reproductive capability, not using a reliable form of contraception
  15. Inability to obtain informed consent from the subject or subject's authorised representative.
  16. Subjects who have participated in another investigative drug study parallel to, or within 4 weeks of study entry.
  17. Known intolerance to mannitol or beta2 agonists.
  18. Uncontrolled hypertension - systolic BP > 160 and or diastoli
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   New Zealand
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00455130
Other Study ID Numbers  ICMJE DPM-CF-201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pharmaxis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Brett Charlton Pharmaxis
PRS Account Pharmaxis
Verification Date January 2010

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