One Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled Steroids (OLIVE)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: AZD1981; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00758589

D9830C00004

Details and patient eligibility

About

The primary objective of this study is to evaluate efficacy of AZD1981 in uncontrolled asthmatic patients on maintenance inhaled glucocorticosteroids.

Enrollment: 368 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Six months history of asthma
• Daily use of inhaled glucocorticosteroids
• FEV1 40-85% of predicted normal
• Reversibility; increase in FEV1 more than 12% and 200 mL post-bronchodilator

Exclusion criteria

• Other clinically relevant disease or disorders
• History of smoking of more than 10 pack years
• Respiratory infection within 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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368 participants in 4 patient groups, including a placebo group

AZD1981 50 mg

Experimental group

Description:

AZD1981 50 mg Twice Daily (Bid)

Treatment:

Drug: AZD1981

Drug: AZD1981

Drug: AZD1981

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

AZD1981 400 mg

Experimental group

Description:

AZD1981 400 mg Twice Daily (Bid)

Treatment:

Drug: AZD1981

Drug: AZD1981

Drug: AZD1981

AZD1981 1000 mg

Experimental group

Description:

AZD1981 1000 mg Twice Daily (Bid)

Treatment:

Drug: AZD1981

Drug: AZD1981

Drug: AZD1981