New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day

Completed · Phase 3

Conditions studied: Asthma

In brief

This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.

Key facts

Study ID

NCT01360021

Run by

AstraZeneca

People needed

214

Starts

2011-11-01

Expected to finish

2012-08-01

Last updated by the study team

2014-03-11

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female 12 years and above
• Clinical diagnosis of asthma according to the American Thoracic Society definition at least 6 months
• Pre-bronchodilator FEV1 ≥ 45% and ≤ 85% of predicted normal
• Patients with reversible airway obstruction
• Documented daily use of inhaled corticosteroids for ≥ 3 months

You may not qualify if…

• History of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures during the 2 years prior to Visit 2
• Hospitalized during previous 6 months for asthma
• Required emergency treatment more than once during previous 6 months for an asthma-related condition
• Intake of oral, rectal or parenteral glucocorticosteroid within 30 days of enrolment
• Respiratory infection affecting the asthma within 30 days

Where it is running

• Research Site — Huntington Beach, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Orange, California, United States
• Research Site — Rancho Mirage, California, United States
• Research Site — Riverside, California, United States
• Research Site — Sacramento, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Jose, California, United States
• Research Site — Tallahassee, Florida, United States
• Research Site — Savannah, Georgia, United States
• Research Site — River Forest, Illinois, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Metairie, Louisiana, United States
• Research Site — Bangor, Maine, United States
• Research Site — Wheaton, Maryland, United States
• Research Site — North Dartmouth, Massachusetts, United States
• Research Site — Columbia, Missouri, United States
• Research Site — Rolla, Missouri, United States
• Research Site — Skillman, New Jersey, United States
• Research Site — North Syracuse, New York, United States
• Research Site — Rochester, New York, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Collegeville, Pennsylvania, United States
• Research Site — Lincoln, Rhode Island, United States

Full record on ClinicalTrials.gov

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