A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: budesonide pMDI

Drug: Symbicort pMDI

Study type

Interventional

Funder types

Industry

Identifiers

NCT01444430

2011-002790-28 (EudraCT Number)

D5896C00027

Details and patient eligibility

About

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

Full description

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.

Enrollment

12,460 patients

Sex

All

Ages

12 to 130 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provision of signed informed consent/ paediatric assent (if applicable) prior to any study specific procedures including medication withdrawal
Male or Female, ≥12 years of age
Documented clinical diagnosis of asthma for at least 1 year prior to Visit 2
Patient must have history of at least 1 asthma exacerbation including one of the following:
- requiring treatment with systemic corticosteroids
- an asthma-related hospitalization between 4 weeks and 12 months prior to randomization
Current Asthma Therapy: Patients must be appropriately using one of the treatments for asthma listed in the protocol combined with achieving certain results when recording an Asthma Control Questionnaire

Exclusion criteria

Patient has a history of life-threatening asthma. Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support.
Patient has required treatment with systemic corticosteroids (tablets, suspensions or injectable) for any reason within 4 weeks prior to Visit 2
Patient has an ongoing exacerbation, defined as a worsening of asthma that requires treatment with systemic corticosteroids (tablets, suspension, or injectable)
An asthma exacerbation within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization or more than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
Patient has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 2 that, in the investigator's opinion, will interfere with the patient's lung function
Patient must not meet unstable asthma severity criteria as listed in the protocol
Peak expiratory flow must not be below 50% o predicted normal
Pregnancy, breast-feeding or planned pregnancy during the study