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

Completed · Phase 3

Conditions studied: Asthma

In brief

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

Key facts

Study ID: NCT01444430
Run by: AstraZeneca
People needed: 12460
Starts: 2011-12-01
Expected to finish: 2015-10-01
Last updated by the study team: 2016-12-15

Who can join

Age: 12 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Research Site — Huntsville, Alabama, United States
Research Site — Anchorage, Alaska, United States
Research Site — Gilbert, Arizona, United States
Research Site — Glendale, Arizona, United States
Research Site — Mesa, Arizona, United States
Research Site — Tucson, Arizona, United States
Research Site — Fort Smith, Arkansas, United States
Research Site — Little Rock, Arkansas, United States
Research Site — Alhambra, California, United States
Research Site — Anaheim, California, United States
Research Site — Arvin, California, United States
Research Site — Bellflower, California, United States
Research Site — Buena Park, California, United States
Research Site — Costa Mesa, California, United States
Research Site — Encinitas, California, United States
Research Site — Escondido, California, United States
Research Site — Fountain Valley, California, United States
Research Site — Glendale, California, United States
Research Site — Long Beach, California, United States
Research Site — Los Angeles, California, United States
Research Site — Newport Beach, California, United States
Research Site — Northridge, California, United States
Research Site — Palmdale, California, United States
Research Site — Pasadena, California, United States
Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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