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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Budesonide; Budesonide, Formoterol Fumarate Drug Combination

Criteria

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