Trial record 1 of 1 for:
NCT00446680
Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy Study
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| ClinicalTrials.gov Identifier: NCT00446680 |
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Recruitment Status :
Completed
First Posted : March 13, 2007
Last Update Posted : June 25, 2010
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Sponsor:
Pharmaxis
Information provided by:
Pharmaxis
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Brief Summary:
The purpose of this study is to determine the efficacy and safety of chronic treatment with inhaled dry powder mannitol in subjects with cystic fibrosis. Previous studies have demonstrated an improvement in lung function related to small airways obstruction and a significant improvement in respiratory symptoms and quality of life after a 2 week treatment with mannitol. This current study seeks to support these early findings and to extend the evidence to support its use as a mucoactive therapy in cystic fibrosis. In particular, the hypothesis that enhanced mucus clearance will improve the lung function and clinical presentation in this population, will be investigated. We also hypothesize that enhanced mucociliary clearance will result in a sustained reduction in mucus load, thus providing less opportunity for bacteria to proliferate, affording a reduction in antibiotic use and hospitalizations. The initial 6 month blinded phase will be followed with an additional 6 months of open label treatment.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cystic Fibrosis | Drug: Mannitol Drug: placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 340 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy Study |
| Study Start Date : | March 2007 |
| Actual Primary Completion Date : | May 2010 |
| Actual Study Completion Date : | May 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Cystic fibrosis
MedlinePlus related topics:
Cystic Fibrosis
Drug Information available for:
Mannitol
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1 |
Drug: Mannitol
400mg BD for 6 months followed by a 6 month open label period |
| Placebo Comparator: 2 |
Drug: placebo
placebo BD for 6 months |
Primary Outcome Measures :
- To determine the effects of 400 mg twice-daily administration of IDPM on FEV1 in patients with CF compared to control [ Time Frame: 6 months ]
Secondary Outcome Measures :
- To determine the effects of 400 mg twice-daily administration of IDPM on FEV1 in patients with CF on existing RhDNase treatment compared to control. (key objective) [ Time Frame: 6 months ]
- Reduces pulmonary exacerbations in those taking RhDNase as a sub-group and in the total cohort (key objective) [ Time Frame: 6 months / 12 months ]
- Improves quality of life (key objective) [ Time Frame: 6 months ]
- Reduces days on IV antibiotics, rescue oral or inhaled antibiotics [ Time Frame: 6 months / 12 months ]
- Reduces days in hospital due to pulmonary exacerbations [ Time Frame: 6 months / 12 months ]
- Improves other measures of lung function [ Time Frame: 6 months ]
- Demonstrates an appropriate safety profile (adverse events, haematology, biochemistry, change in bronchodilator response, sputum microbiology, physical examination) [ Time Frame: 6 months / 12 months ]
- Reduces hospital and community care costs [ Time Frame: 6 months / 12 months ]
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| Ages Eligible for Study: | 6 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Main Inclusion Criteria:
- Written informed consent
- Confirmed diagnosis of cystic fibrosis
- Aged > 6 years
- FEV1 >30 % and < 90% predicted
- Able to perform all the techniques necessary to measure lung function
Main Exclusion Criteria:
- "Terminally ill" or listed for lung transplantation
- Had a lung transplant
- Using nebulised hypertonic saline
- Significant episode of haemoptysis (>60 mL) in the three months prior to enrolment
- Recent myocardial infarction or cerebral vascular accident
- Breast feeding or pregnant, or plan to become pregnant while in the study participating in another investigative drug study, parallel to, or within 4 weeks of study entry
- Allergy or intolerance to mannitol
- Using beta blockers
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446680
Locations
Show 29 study locations
Sponsors and Collaborators
Pharmaxis
Investigators
| Study Director: | Brett Charlton, MBBS | Pharmaxis Ltd Australia | |
| Principal Investigator: | Dr Diana Bilton | Papworth Hospital Cambridge, UK | |
| Principal Investigator: | Dr Philip Robinson | Royal Children's Hospital Melbourne Australia |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Brett Charlton, Pharmaxis Ltd |
| ClinicalTrials.gov Identifier: | NCT00446680 |
| Other Study ID Numbers: |
DPM-CF-301 |
| First Posted: | March 13, 2007 Key Record Dates |
| Last Update Posted: | June 25, 2010 |
| Last Verified: | June 2010 |
Keywords provided by Pharmaxis:
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Mannitol Cystic Fibrosis Mucolytic |
Exacerbation FEV1 Quality of Life |
Additional relevant MeSH terms:
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Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases |
Genetic Diseases, Inborn Infant, Newborn, Diseases Mannitol Diuretics, Osmotic Diuretics Natriuretic Agents Physiological Effects of Drugs |