Study Stopped
Technical problems with measure of CFU's. Outcomes published: PMID:16986483
Alpha1 Antitrypsin Aerosol Therapy in Cystic Fibrosis
Effects of Prolastin Aerosol Therapy on Bacterial Density in the Airways of Patients With Cystic Fibrosis
1 other identifier
interventional
17
1 country
1
Brief Summary
The hypothesis being tested is that inhibition of the enzyme known as elastase in the airways of patients with cystic fibrosis will help decrease the number of bacteria. Alpha1 antitrypsin, an elastase inhibitor, will be given to patients with cystic fibrosis by aerosol therapy twice in 1 day and sputum will be collected to measure the density of bacteria
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2004
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 9, 2013
CompletedFirst Posted
Study publicly available on registry
December 12, 2013
CompletedDecember 12, 2013
December 1, 2013
4 months
December 9, 2013
December 11, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Bacterial density in sputum as determined by colony forming units at 2, 4 and 6 hours after Prolastin therapy.
6 hours after Prolastin
Secondary Outcomes (3)
Neutrophil burden in airways as determined by sputum myeloperoxidase;
6 hours after Prolastin
Sputum elastase activity
6 hours after Prolastin
Alpha1 antitrypsin in sputum
6 hours after Prolastin
Study Arms (1)
Prolastin
ACTIVE COMPARATORProlastin 250 mg nebulized BID, 10 days
Interventions
Outcomes compared to saline or no intervention in each subject.
Eligibility Criteria
You may qualify if:
- Diagnosis of cystic fibrosis
- Age 14 years and older
- Women must have a negative pregnancy test and used effective contraception
- Must be able to produce sputum
- Sputum culture positive for Pseudomonas aeruginosa
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre de Recherche du CHUS
Sherbrooke, Quebec, J1H 5N4, Canada
Related Publications (1)
McElvaney NG, Hubbard RC, Birrer P, Chernick MS, Caplan DB, Frank MM, Crystal RG. Aerosol alpha 1-antitrypsin treatment for cystic fibrosis. Lancet. 1991 Feb 16;337(8738):392-4. doi: 10.1016/0140-6736(91)91167-s.
PMID: 1671425BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andre Cantin, md
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
December 9, 2013
First Posted
December 12, 2013
Study Start
June 1, 2004
Primary Completion
October 1, 2004
Study Completion
October 1, 2005
Last Updated
December 12, 2013
Record last verified: 2013-12