Alpha1 Antitrypsin Aerosol Therapy in Cystic Fibrosis
Information source: Université de Sherbrooke
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cystic Fibrosis
Intervention: Prolastin (drug) (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Université de Sherbrooke Official(s) and/or principal investigator(s): Andre Cantin, md, Principal Investigator, Affiliation: Centre Hospitalier Universitaire de Sherbrooke
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
Clinical Details
Official title: Effects of Prolastin Aerosol Therapy on Bacterial Density in the Airways of Patients With Cystic Fibrosis
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bacterial density in sputum as determined by colony forming units at 2, 4 and 6 hours after Prolastin therapy.
Secondary outcome: Neutrophil burden in airways as determined by sputum myeloperoxidase;Sputum elastase activity Alpha1 antitrypsin in sputum
Detailed description:
Cystic fibrosis is usually characterized by chronic bacterial infections of the airways.
Neutrophils release the enzyme elastase in the airways and this enzyme can prevent the
ingestion and killing of bacteria by the airway phagocytic cells. The hypothesis being
tested is that inhibition of elastase in the airways will help neutrophils decrease the
number of bacteria. Each subject with cystic fibrosis will first undergo aerosol therapy
with a sterile saline solution and sputum will be collected 2, 4 and 6 hours after the
aerosol therapy to measure the density of bacteria. Subsequently, alpha1 antitrypsin, an
elastase inhibitor, will be given to the same patients by aerosol therapy twice in 1 day and
sputum will be collected at 2, 4 and 6 hours after treatment to measure the density of
bacteria. The results will be compared to those obtained after after aerosol therapy with
saline solution.
Study phase II
Study type Interventional
Study design Purpose - treatment Allocation - nonrandomized trial Masking - open Control -
active Assignment - cross-over Endpoint - efficacy
Primary Outcome Measure Bacterial density in sputum as determined by colony forming units at
2, 4 and 6 hours after Prolastin therapy.
Eligibility
Minimum age: 14 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
-
Locations and Contacts
Centre de Recherche du CHUS, Sherbrooke, Quebec J1H 5N4, Canada
Additional Information
Related publications: 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.
Starting date: June 2004
Last updated: December 11, 2013
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