Advanced Immunological Approach in COPD Exacerbation

PHASE4CompletedINTERVENTIONAL
Enrollment

288

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

July 31, 2013

Study Completion Date

July 31, 2013

Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
BIOLOGICAL

Placebo

"1. The placebo will be administered for a period of three months. The first ten days of each month, one tablet per day will be given. The tablet will be melted under the tongue. After the ten day therapy, a twenty day of rest will be provided. Then the second and the third month the administration schedule will be identical.~2. Three months of rest, according to the indications, will be allowed.~3. A second cycle (the same as point 1.) will be performed~4. A second three month rest (according to point 2.) will be provided."

BIOLOGICAL

Ismigen

"1. The tablet will be administered for a period of three months. The first ten days of each month, one tablet per day will be given. The tablet will be melted under the tongue. After the ten day therapy, a twenty day of rest will be provided. Then the second and the third month the administration schedule will be identical.~2. Three months of rest, according to the indications, will be allowed.~3. A second cycle (the same as point 1.) will be performed~4. A second three month rest (according to point 2.) will be provided."

Trial Locations (13)

20142

Pneumology Department - San Paolo Hospital, Milan

27100

Respiratory and Pulmonary desease Unit - IRCCS San Matteo, Pavia

Unknown

Respiratory Physiopatology and Pneumology Unit, Di Circolo Predabissi-Melegnano hospital, Vizzolo Predabissi

"Specialistic Rehabilitation (Pneumolgi Unit),Carlo Mira hospital", Casorate Primo

Rehabilitation Pneumology Unit, IRCCS San Raffaele Pisana, Rome

Respiratory Clinical Pharmacology, Department of Internal Medicine, Tor Vergata Hospital, Rome

Broncopneumology and Allergology Unit, Abbiategrasso hospital, Abbiategrasso

Respiratory Physiopatology Unit, Mellino Mellini hospital, Chiari

Pneumology Unit, Cremona hospital, Cremona

Allergy and Respiratory Diseases Clinic, San Martino hospital, Genova

Pneumology Unit, San Gerardo hospital, Monza

Complex structure of Pulmonary Allergy, Cardarelli hospital, Naples

Complex structure of Pulmonary Rehabilitation, Cardarelli hospital, Naples

Sponsors
All Listed Sponsors
collaborator

Sprim Advanced Life Sciences

OTHER

lead

Lallemand Pharma AG

INDUSTRY

NCT02417649 - Advanced Immunological Approach in COPD Exacerbation | Biotech Hunter | Biotech Hunter