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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

Page last updated: August 23, 2015

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