IMPACTT

Immunoglobulin IgY pseudomonas A clinical trial for cystic fibrosis treatment

Coordinatore	UPPSALA UNIVERSITET    more  Organization address address: SANKT OLOFSGATAN 10 B city: UPPSALA postcode: 751 05 contact info Titolo: Prof. Nome: Anders Cognome: Larsson Email: send email Telefono: +46 18 611 4271 Fax: +46 18 552562
Nazionalità Coordinatore	Sweden [SE]
Totale costo	7˙055˙166 €
EC contributo	5˙376˙180 €
Programma	FP7-HEALTH Specific Programme "Cooperation": Health
Code Call	FP7-HEALTH-2010-single-stage
Funding Scheme	CP-FP
Anno di inizio	2011
Periodo (anno-mese-giorno)	2011-01-01   -   2016-12-31

 Partecipanti

#	participant	country	role	EC contrib. [€]
1	UPPSALA UNIVERSITET  Organization address address: SANKT OLOFSGATAN 10 B city: UPPSALA postcode: 751 05 contact info Titolo: Prof. Nome: Anders Cognome: Larsson Email: send email Telefono: +46 18 611 4271 Fax: +46 18 552562	SE (UPPSALA)	coordinator	570˙971.60
2	Immun System I.M.S. AB  Organization address address: Dag Hammerskjoelds Vaeg 26 city: UPPSALA postcode: 75183 contact info Titolo: Prof. Nome: Hans Cognome: Kollberg Email: send email Telefono: 4618104321 Fax: 4618538997	SE (UPPSALA)	participant	1˙980˙700.00
3	Nome Ente NON disponibile  Organization address address: IN DEN DAUEN 6 city: BONN postcode: 53117 contact info Titolo: Dr. Nome: Andreas Cognome: Reimann Email: send email Telefono: +49 228 9878012 Fax: +49 228 9878077	DE (BONN)	participant	1˙305˙000.00
4	HEINRICH-HEINE-UNIVERSITAET DUESSELDORF  Organization address address: UNIVERSITAETSSTRASSE 1 city: DUSSELDORF postcode: 40225 contact info Titolo: Prof. Nome: Christian Cognome: Ohmann Email: send email Telefono: 492118000000 Fax: 492118000000	DE (DUSSELDORF)	participant	625˙900.00
5	REGION HOVEDSTADEN  Organization address address: KONGENS VAENGE 2 city: HILLEROD postcode: 3400 contact info Titolo: Prof. Nome: Bjarnsholt Cognome: Thomas Email: send email Telefono: +45 20 65 98 88 Fax: 4535456412	DK (HILLEROD)	participant	469˙280.00
6	CONSORZIO ITALIANO PER LA RICERCA MEDICA  Organization address address: Viale Zara - Istituto Villa Marelli 81 city: MILANO postcode: 20159 contact info Titolo: Mr. Nome: Alfonso Cognome: Sassun Email: send email Telefono: 393478000000 Fax: 390270000000	IT (MILANO)	participant	122˙800.00
7	CYSTIC FIBROSIS EUROPE EV  Organization address address: IN DEN DAUEN 6 city: BONN postcode: 53117 contact info Titolo: Mrs. Nome: Birgit Cognome: Dembski Email: send email Telefono: +49 228 98 780 Fax: +49 228 98 7877	DE (BONN)	participant	113˙520.36
8	VALSTYBINIS MOKSLINIU TYRIMU INSTITUTAS INOVATYVIOS MEDICINOS CENTRAS  Organization address address: ZYGIMANTU 9 city: VILNIUS postcode: 1102 contact info Titolo: Prof. Nome: Algirdas Cognome: Venalis Email: send email Telefono: 3702614868 Fax: +370 2123073	LT (VILNIUS)	participant	90˙000.00
9	STOCKHOLMS LAENS LANDSTING  Organization address address: Hantverkargatan 45 city: STOCKHOLM postcode: 104 22 contact info Titolo: Ms. Nome: Anna Cognome: Käll Email: send email Telefono: 46858585778 Fax: +4608 585 869 20	SE (STOCKHOLM)	participant	78˙600.00
10	INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)  Organization address address: 101 Rue de Tolbiac city: PARIS postcode: 75654 contact info Titolo: Ms. Nome: Annick Cognome: Bertault Email: send email Telefono: 33140784901 Fax: 33140784998	FR (PARIS)	participant	19˙408.04

Mappa

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 Obiettivo del progetto (Objective)

'Cystic Fibrosis (CF) is a chronically debilitating and life threatening medical condition. Respiratory insufficiency and complications of chronic lung infection lead to long term reduction in quality of life and health and even to premature death. Chronic bacterial infections with Pseudomonas aeruginosa (PA), Staphylococcus aureus and Haemophilus influezae are typical for CF and repeated courses of antibiotics in heavy doses has more than doubled the median survival age. No preventive or eradicative treatments of PA infection in the lungs exist today. The most significant bacterial pathogen associated with CF pulmonary disease is PA. PA is an opportunistic, life-threatening gram-negative bacteria which produces various immune modulatory products enabling it to survive in the lungs and cause morbidity and mortality. CF patients are particularly at risk of infection due to the viscous mucus lining their airways, which compromises their respiratory function.

The European Medicines Agency granted “Anti-pseudomonas IgY” an Orphan Drug Designation in September 2008, and paediatric CF product development was encouraged. The IMPACTT project will perform a clinical phase III trial, to demonstrate the critical preventive and therapeutic effects of this pioneering intervention therapy for the fatal chronic infection of Pseudomonas aeruginosa in CF patients. The project mobilises the critical mass of experts from academia, patient organisations, clinical trials managers, clinicians and industry aiming to eradicate PA infection in CF patient lungs and thereby alleviate the negative impact of PA on the quality of life of CF patients and their families.

Despite good results with antibiotics, continuous pulmonary deterioration and death of the CF patient is a reality. Alternative therapeutic strategies are badly needed. Our phase I and II clinical studies prove that a single daily gargle with the proposed Anti-Pseudomonas IgY solution significantly improves the condition.'

Introduzione (Teaser)

A European study is exploring the administration of hen antibodies as a novel way of fighting infections in patients with cystic fibrosis (CF). The results have the potential to minimise the emergence of resistant bacteria as a result of prolonged antibiotic use.