Asthma

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

Status: Recruiting

Phase: 3

Sponsor: AstraZeneca

Contact: Mollie Ball, 541-706-6594 or mball@bmctotalcare.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.

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

See this trial at ClinicalTrials.gov

For general inquiries, please contact the BMC Research Department at research@bmctotalcare.com or 877-692-8338.

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