RhDNase and Biodistribution of PMN Serine Proteases in Cystic Fibrosis Sputum (BioDNase)
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ClinicalTrials.gov Identifier: NCT00843817 |
Recruitment Status :
Completed
First Posted : February 13, 2009
Last Update Posted : February 27, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cystic Fibrosis | Drug: Pulmozyme | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | RhDNase Effect on Biodistribution of PMN Serine Proteases in Cystic Fibrosis Sputum |
Actual Study Start Date : | April 2009 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | April 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: DRUG
PULMOZYME
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Drug: Pulmozyme
Pulmozyme® 2.5mg by inhalation |
- The biodistribution of elastase, Protease 3 and cathepsine G in the expectorations will be measured by the management report of these proteases between the freezing fractionand the soluble fraction, before and after rhDNase administration. [ Time Frame: 1 hour ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- cystic fibrosis disease
- with rhDNase treatment
Exclusion Criteria:
- Acute push of the bronchopulmonary attack or hospitalization for treatment of the disease during 2 weeks previous
- Exposure to a antibiotherapy or treatment by corticoids

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): NCT00843817
France | |
University Hospital - Tours | |
Tours, France |
Principal Investigator: | Patrice DIOT, PHD | University Hospital, Tours |
Responsible Party: | University Hospital, Tours |
ClinicalTrials.gov Identifier: | NCT00843817 |
Other Study ID Numbers: |
PHAO08-PD BioDNase |
First Posted: | February 13, 2009 Key Record Dates |
Last Update Posted: | February 27, 2017 |
Last Verified: | February 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
cystic fibrosis |
Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |