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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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