Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Asthma Patients

In brief

The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active compound in asthmatic patients.

Key facts

Study ID

NCT01197794

Run by

AstraZeneca

People needed

1144

Starts

2010-10-01

Expected to finish

2012-02-01

Last updated by the study team

2013-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception
• 6 months history of asthma according to ATS definition
• Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2
• Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal
• A total ACQ5 score of 1.5 or more

You may not qualify if…

• Respiratory infection significantly affecting the asthma
• Any significant disease and disorder that may put the patient at risk or influence study results
• Any clinically relevant abnormal findings
• A smoking history of more than 10 pack years
• Intake of oral, rectal or parenteral glucocorticosteroids

Where it is running

• Research Site — Los Angeles, California, United States
• Research Site — Mission Viejo, California, United States
• Research Site — Rolling Hills Estates, California, United States
• Research Site — San Diego, California, United States
• Research Site — San Jose, California, United States
• Research Site — Wheaton, Maryland, United States
• Research Site — North Dartmouth, Massachusetts, United States
• Research Site — Bellevue, Nebraska, United States
• Research Site — Sylvania, Ohio, United States
• Research Site — Oklahoma City, Oklahoma, United States
• Research Site — Medford, Oregon, United States
• Research Site — Portland, Oregon, United States
• Research Site — Collegeville, Pennsylvania, United States
• Research Site — Pittsburgh, Pennsylvania, United States
• Research Site — Charleston, South Carolina, United States
• Research Site — Clinton, South Carolina, United States
• Research Site — Waco, Texas, United States
• Research Site — Tacoma, Washington, United States
• Research Site — Buenos Aires, Argentina, Argentina
• Research Site — Quilmes, Buenos Aires, Argentina
• Research Site — Mendoza, Mendoza Province, Argentina
• Research Site — Rosario, Santa Fe Province, Argentina
• Research Site — San Miguel de Tucumán, Tucumán Province, Argentina
• Research Site — Porto Alegre, Brasil, Brazil
• Research Site — Fullerton, California, United States

Full record on ClinicalTrials.gov

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