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Anti-pseudomonas IgY to Prevent Infections in Cystic Fibrosis (PseudIgY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Immunsystem AB
ClinicalTrials.gov Identifier:
NCT00633191
First received: March 4, 2008
Last updated: August 31, 2016
Last verified: August 2016
  Purpose
Hypothesis: Daily gargling with specific avian antibodies against Pseudomonas aeruginosa will prevent infections with this bacteria in patients with Cystic fibrosis (CF).

Condition Intervention Phase
Cystic Fibrosis
Infection
Pseudomonas Aeruginosa
Drug: Anti-pseudomonas IgY gargle
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Post Marketing Study of Anti-pseudomonas IgY in Prevention of Recurrence of Pseudomonas Aeruginosa Infections Infections in Cystic Fibrosis (CF) Patients

Resource links provided by NLM:


Further study details as provided by Immunsystem AB:

Primary Outcome Measures:
  • Sputum culture positive for Pseudomonas aeruginosa [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pulmonary function [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: November 2003
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anti-pseudomonas IgY gargle
Intervention: Gargles with anti-pseudomonas IgY every night
Drug: Anti-pseudomonas IgY gargle
Gargle (solution), > 5FKU, every night after toothbrushing, life-long
Other Names:
  • oral immunotherapy
  • Yolk antiboidies

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Egg allergy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633191

Locations
Sweden
Cystic fibrosis centre,Children´s University Hospital
Uppsala, Sweden, SE-751 85
Sponsors and Collaborators
Immunsystem AB
Investigators
Principal Investigator: Annika Hollsing, MD, PhD Uppsala Children´s University Hospital
  More Information

Publications:

Responsible Party: Immunsystem AB
ClinicalTrials.gov Identifier: NCT00633191     History of Changes
Other Study ID Numbers: Pseud-IgY-1 
Study First Received: March 4, 2008
Last Updated: August 31, 2016
Health Authority: Sweden: Medical Products Agency
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Immunsystem AB:
Cystic fibrosis
Prevention
Infection
Pseudomonas aeruginosa
Gargle

Additional relevant MeSH terms:
Infection
Communicable Diseases
Fibrosis
Cystic Fibrosis
Pseudomonas Infections
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 28, 2016