Study identifier:D5896C00027
ClinicalTrials.gov identifier:NCT01444430
EudraCT identifier:2011-002790-28
CTIS identifier:N/A
A 26 week, randomized, double-blind, parallel-group, active controlled, multicenter, multinational safety study evaluating the risk of serious asthma-related events during treatment with Symbicort®, a fixed combination of inhaled corticosteroid (ICS) (budesonide) and a long acting β2-agonist (LABA) (formoterol) as compared to treatment with ICS (budesonide) alone in adult and adolescent (≥12 years of age) patients with asthma
asthma
Phase 3
No
Symbicort pMDI, budesonide pMDI
All
12460
Interventional
12 Years - 130 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Nov 2016 by AstraZeneca
AstraZeneca
-
The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma
A 26 week, randomized, double-blind, parallel-group, active controlled, multicenter, multinational safety study evaluating the risk of serious asthma-related events during treatment with Symbicort®, a fixed combination of inhaled corticosteroid (ICS) (budesonide) and a long acting β2-agonist (LABA) (formoterol) as compared to treatment with ICS (budesonide) alone in adult and adolescent (≥12 years of age) patients with asthma.
Location
Location
Buenos Aires, Argentina
Location
Monte Grande, Argentina
Location
Quilmes, Argentina
Location
Ranelagh, Argentina
Location
Córdoba, Argentina
Location
San Miguel de Tucuman, Argentina
Location
San Miguel de Tucumán, Argentina
Location
Ciudad de Buenos Aires, Argentina
Arms | Assigned Interventions |
---|---|
Experimental: 1 Symbicort | Drug: Symbicort pMDI Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening), for oral inhalation. |
Active Comparator: 2 budesonide | Drug: budesonide pMDI Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening), for oral inhalation. |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.