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Long Term Administration of Inhaled 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.
 
ClinicalTrials.gov Identifier: NCT00630812
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : August 15, 2012
Sponsor:
Collaborators:
ethica Clinical Research Inc.
Europe: KasaConsult bvba, Hoegaarden, Belgium
Argentina: Resolution Latin America; Buenos Aires, Argentina
Information provided by (Responsible Party):
Pharmaxis

Tracking Information
First Submitted Date  ICMJE February 27, 2008
First Posted Date  ICMJE March 7, 2008
Last Update Posted Date August 15, 2012
Study Start Date  ICMJE September 2008
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2010)
Change in absolute FEV1 [ Time Frame: 26 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 27, 2008)
FEV1 [ Time Frame: 26 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long Term Administration of Inhaled Mannitol in Cystic Fibrosis
Official Title  ICMJE Long Term Administration of Inhaled Mannitol in Cystic Fibrosis- A Safety and Efficacy Study
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: A
    active treatment
    Intervention: Drug: inhaled mannitol
  • Placebo Comparator: B
    Intervention: Drug: Placebo comparator
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2010)
318
Original Estimated Enrollment  ICMJE
 (submitted: February 27, 2008)
250
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Have given written informed consent to participate in this study in accordance with local regulations
  2. Have a confirmed diagnosis of cystic fibrosis (positive sweat chloride value ≥ 60 mEq/L) and/or genotype with two identifiable mutations consistent with CF, accompanied by one or more clinical features consistent with the CF phenotype)
  3. Be aged > 6 years old
  4. Have FEV1 >40 % and < 90% predicted
  5. Be able to perform all the techniques necessary to measure lung function

Exclusion Criteria:

  1. Investigators, site personnel directly affiliated with this study, or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.
  2. Be considered "terminally ill" or eligible for lung transplantation
  3. Have had a lung transplant
  4. Be using nebulized hypertonic saline in the 4 weeks prior to visit 1
  5. Have had a significant episode of hemoptysis (>60 mL) in the three months prior to enrolment
  6. Have had a myocardial infarction in the three months prior to enrolment
  7. Have had a cerebral vascular accident in the three months prior to enrolment
  8. Have had major ocular surgery in the three months prior to enrolment
  9. Have had major abdominal, chest or brain surgery in the three months prior to enrolment
  10. Have a known cerebral, aortic or abdominal aneurysm
  11. Be breast feeding or pregnant, or plan to become pregnant while in the study
  12. Be using an unreliable form of contraception (female subjects at risk of pregnancy only)
  13. Be participating in another investigative drug study, parallel to, or within 4 weeks of visit 0
  14. Have a known allergy to mannitol
  15. Be using beta blockers
  16. Have uncontrolled hypertension - systolic BP > 190 and / or diastolic BP > 100
  17. Have a condition or be in a situation which in the Investigator's opinion may put the subject at significant risk, may confound results or may interfere significantly with the patient's participation in the study
  18. Be 'Mannitol Tolerance Test positive'

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 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 Argentina,   Belgium,   Canada,   France,   Germany,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00630812
Other Study ID Numbers  ICMJE DPM-CF-302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pharmaxis
Study Sponsor  ICMJE Pharmaxis
Collaborators  ICMJE
  • ethica Clinical Research Inc.
  • Europe: KasaConsult bvba, Hoegaarden, Belgium
  • Argentina: Resolution Latin America; Buenos Aires, Argentina
Investigators  ICMJE
Principal Investigator: Moira L Aitken, MD University of Washington Medical Centre, Seattle WA
PRS Account Pharmaxis
Verification Date August 2012

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