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Alpha1 Antitrypsin Aerosol Therapy in Cystic Fibrosis

NCT ID: NCT02010411

Last Updated: 2013-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-10-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prolastin

Prolastin 250 mg nebulized BID, 10 days

Group Type ACTIVE_COMPARATOR

Prolastin (drug)

Intervention Type DRUG

Outcomes compared to saline or no intervention in each subject.

Interventions

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Prolastin (drug)

Outcomes compared to saline or no intervention in each subject.

Intervention Type DRUG

Other Intervention Names

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Alpha1 antitrypsin

Eligibility Criteria

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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

\-
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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André Cantin

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andre Cantin, md

Role: PRINCIPAL_INVESTIGATOR

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Locations

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Centre de Recherche du CHUS

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 1671425 (View on PubMed)

Other Identifiers

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04-038

Identifier Type: -

Identifier Source: org_study_id