288
Participants
Start Date
September 30, 2009
Primary Completion Date
July 31, 2013
Study Completion Date
July 31, 2013
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."
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."
Pneumology Department - San Paolo Hospital, Milan
Respiratory and Pulmonary desease Unit - IRCCS San Matteo, Pavia
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
Lead Sponsor
Sprim Advanced Life Sciences
OTHER
Lallemand Pharma AG
INDUSTRY