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Clinical Trials/NCT00633191
NCT00633191CompletedPhase 1

Post Marketing Study of Anti-pseudomonas IgY in Prevention of Recurrence of Pseudomonas Aeruginosa Infections Infections in Cystic Fibrosis (CF) Patients

Immunsystem AB1 site in 1 country14 target enrollmentStarted: November 2003Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
14
Locations
1
Primary Endpoint
Sputum culture positive for Pseudomonas aeruginosa

Study Overview

Brief Summary

Hypothesis: Daily gargling with specific avian antibodies against Pseudomonas aeruginosa will prevent infections with this bacteria in patients with Cystic fibrosis (CF).

Detailed Description

"Anti-pseudomonas IgY" is prepared from eggs of hens that have been vaccinated with Pseudomonas aeruginosa. The hens farm is under veterinary control according to Swedish rules. The drug is prepared with a water dilution method according to GMP standards (approved by Swedish MPA). Patients with CF who are intermittently but not chronically infected with P. aeruginosa get a short course of antibiotics to eradicate the bacteria. Thereafter they start to gargle with a solution of "anti-pseudomonas IgY" every night to prevent a new infection. Preliminary results have shown that it takes a significantly longer time to get a new infection and that the patients get fewer infections than control patients. In addition, results tentatively indicate that: patients have not got any new opportunistic bacteria or fungi (B. Cepacia, S. Maltophilia, A. Xylosoxidans, atypical Mycobacteria, Aspergillus Fumigatus); that use of antibiotics is greatly diminished; that the lung functions and nutritional conditions are maintained.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Clinical diagnosis of cystic fibrosis
  • Colonized with Pseudomonas aeruginosa
  • informed consent

Exclusion Criteria

  • Egg allergy

Arms & Interventions

Anti-pseudomonas IgY gargle

Experimental

Intervention: Gargles with anti-pseudomonas IgY every night

Intervention: Anti-pseudomonas IgY gargle (Drug)

Outcomes

Primary Outcomes

Sputum culture positive for Pseudomonas aeruginosa

Time Frame: Prospective

Secondary Outcomes

  • Pulmonary function(Prospective)

Investigators

Sponsor
Immunsystem AB
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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