This trial is active, not recruiting.

Conditions cystic fibrosis, infection, pseudomonas aeruginosa
Treatment anti-pseudomonas igy gargle
Phase phase 1/phase 2
Sponsor Immunsystem AB
Start date November 2003
End date December 2018
Trial size 20 participants
Trial identifier NCT00633191, Pseud-IgY-1


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
(Active Comparator)
Intervention: Gargles with anti-pseudomonas IgY every night
anti-pseudomonas igy gargle oral immunotherapy
Gargle (solution), > 5FKU, every night after toothbrushing, life-long
(No Intervention)
Intervention: No oral IgY treatment

Primary Outcomes

Sputum culture positive for Pseudomonas aeruginosa
time frame: Prospective

Secondary Outcomes

Pulmonary function
time frame: Prospective

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Clinical diagnosis of cystic fibrosis - Colonized with Pseudomonas aeruginosa - informed consent Exclusion Criteria: - Egg allergy

Additional Information

Official title Post Marketing Study of Anti-pseudomonas IgY in Prevention of Recurrence of Pseudomonas Aeruginosa Infections Infections in Cystic Fibrosis (CF) Patients
Principal investigator Annika Hollsing, MD, PhD
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 and FDA rules. The drug is prepared with a water dilution method by Fresenius-Kabi AB 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, they have not got any of the otherwise for CF patients common new opportunistic bacteria or fungi (B. Cepacia, S. Maltophilia, A. Xylosoxidans, atypical Mycobacteria, Aspergillus Fumigatus). The use of antibiotics is greatly diminished. The lung functions and nutritional conditions are maintained good.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Immunsystem AB.