NCT01912872 - Study to Assess the Efficacy and Safety of Omalizumab Treatment on ICS Reduction for Severe IgE-mediated Asthma | Biotech Hunter

Enrollment

112

Participants

Timeline

Start Date

November 11, 2013

Primary Completion Date

August 6, 2015

Study Completion Date

January 8, 2016

Conditions

Severe IgE-mediated Asthma

Interventions

DRUG

Omalizumab

Subcutaneous injection dose according to the IgE level and body weight.

DRUG

Budesonide

Budesonide (400 μg, 200 μg or 100 μg) tablets taken orally according to maximum daily dose.

DRUG

Formoterol

Formoterol 12ug tablets taken orally according to maximum daily dose.

DRUG

Budesonide

Budesonide (400 μg, 200 μg or 100 μg). Patients were instructed to take the inhaled budesonide doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.

DRUG

Formoterol

Formoterol 12ug. Patients were instructed to take the inhaled formoterol doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.

Trial Locations (21)

14000

Novartis Investigative Site, Mexico City

14050

Novartis Investigative Site, Mexico City

29030

Novartis Investigative Site, Tuxtla Gutiérrez

42090

Novartis Investigative Site, Pachuca

44500

Novartis Investigative Site, Guadalajara

Novartis Investigative Site, Guadaljara

44600

Novartis Investigative Site, Guadalajara

44620

Novartis Investigative Site, Guadalajara

44690

Novartis Investigative Site, Guadalajara

53910

Novartis Investigative Site, México

57730

Novartis Investigative Site, Nezahualcóyotl

63000

Novartis Investigative Site, Tepic

64020

Novartis Investigative Site, Monterrey

64718

Novartis Investigative Site, Monterrey

97070

Novartis Investigative Site, Mérida

03020

Novartis Investigative Site, Mexico City

03100

Novartis Investigative Site, Mexico City

04700

Novartis Investigative Site, Mexico City

04980

Novartis Investigative Site, Mexico City

06090

Novartis Investigative Site, Mexico City

06760

Novartis Investigative Site, Mexico City