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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Asthma Patients

Treatments: Drug: Placebo; Drug: AZD1981

Study type: Interventional

Funder types: Industry

Identifiers

NCT01197794

D9830C00008

2010-020407-73 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 1,144 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,144 participants in 7 patient groups, including a placebo group

AZD1981 10 mg

Experimental group

Description:

AZD1981 10 mg

Treatment:

Drug: AZD1981

Drug: AZD1981

AZD1981 40 mg

Experimental group

Description:

AZD1981 40 mg

Treatment:

Drug: AZD1981

Drug: AZD1981

AZD1981 100 mg

Experimental group

Description:

AZD1981 100 mg

Treatment:

Drug: AZD1981

Drug: AZD1981

AZD1981 400 mg

Experimental group

Description:

AZD1981 400 mg

Treatment:

Drug: AZD1981

Drug: AZD1981

AZD1981 80 mg

Experimental group

Description:

AZD1981 80 mg

Treatment:

Drug: AZD1981

Drug: AZD1981

AZD1981 200 mg

Experimental group

Description:

AZD1981 200 mg

Treatment:

Drug: AZD1981

Drug: AZD1981

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo