THIS TRIAL IS NOW CLOSED
Clinical trial comparing the risk of asthma-related events for two FDA-approved drugs
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
Investigator: Adam Williams, MD
Contact: Mollie Ball, 541-706-6594 or email@example.com
Location: Bend, Oregon (Central Oregon)
Purpose: 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.
- 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
- 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
For general inquiries, please contact the BMC Research Department at firstname.lastname@example.org or 877-692-8338.