Alpha1 Antitrypsin Aerosol Therapy in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Effects of Prolastin Aerosol Therapy on Bacterial Density in the Airways of Patients With Cystic Fibrosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02010411
• Other study ID #: 04-038
• Status: Terminated
• Phase: Phase 2
• First received: December 9, 2013
• Last updated: December 11, 2013
• Start date: June 2004
• Est. completion date: October 2005

Study information

• Verified date: December 2013
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: October 2005
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Prolastin (drug)
Outcomes compared to saline or no intervention in each subject.

Locations

Country	Name	City	State
Canada	Centre de Recherche du CHUS	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial density in sputum as determined by colony forming units at 2, 4 and 6 hours after Prolastin therapy.		6 hours after Prolastin	No
Secondary	Neutrophil burden in airways as determined by sputum myeloperoxidase;		6 hours after Prolastin	No
Secondary	Sputum elastase activity		6 hours after Prolastin	No
Secondary	Alpha1 antitrypsin in sputum		6 hours after Prolastin	No