Efficacy and Safety of Tigerase® vs. Pulmozyme® in Patients With Cystic Fibrosis

PHASE3CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

August 30, 2017

Primary Completion Date

May 16, 2018

Study Completion Date

May 16, 2018

Conditions
Cystic FibrosisFibrosis
Interventions
BIOLOGICAL

Tigerase®

2.5 mL (2.5 mg) dornase alfa nebulized once daily for 168 (+/-7) days

BIOLOGICAL

Pulmozyme®

2.5 mL (2.5 mg) dornase alfa nebulized once daily for 168 (+/-7) days

Trial Locations (14)

105077

City Clinical Hospital named after D.D. Pletnev, Moscow

150003

"Children's Clinical Hospital No. 1 , Cystic Fibrosis center", Yaroslavl

150010

Clinical hospital No. 2, Yaroslavl

194354

City Multidisciplinary Hospital No. 2, Saint Petersburg

295007

Crimean federal university named after V.I.Vernadsky, Simferopol

355000

Scientific medical center of General Medicine and pharmacologies, Stavropol

400066

Volgograd State Medical University, Department of clinical pharmacology and intensive care, Volgograd

410053

Regional clinical Hospital, Saratov

420012

Kazan state medical University of Ministry of health, Hospital Therapy Department, Kazan'

450005

Republican Clinical hospital named after G.G. Kuvatov, Ufa

454076

Chelyabinsk Regional Clinical hospital, Chelyabinsk

620102

Sverdlovsk Regional clinical hospital No. 1, Yekaterinburg

634050

Tomsk national medical research Center of the Russian Academy of Sciences, Genetic Clinic Research Institute medical genetics, Tomsk

656024

Regional Clinical Hospital, Barnaul

All Listed Sponsors
lead

AO GENERIUM

INDUSTRY

NCT04468100 - Efficacy and Safety of Tigerase® vs. Pulmozyme® in Patients With Cystic Fibrosis | Biotech Hunter | Biotech Hunter