Status:
COMPLETED
Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients
Lead Sponsor:
AstraZeneca
Conditions:
Asthma Patients
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active compound in asthmatic patients.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
1144 Patients enrolled
Trial Details
Trial ID
NCT01197794
Start Date
October 1 2010
End Date
February 1 2012
Last Update
November 6 2013
Active Locations (105)
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1
Research Site
Fullerton, California, United States
2
Research Site
Los Angeles, California, United States
3
Research Site
Mission Viejo, California, United States
4
Research Site
Rolling Hills Estates, California, United States