A Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at Three Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: AZD9668; Drug: AZD9668 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00949975

D0520C00012

Details and patient eligibility

About

The primary objective is to evaluate the dose-response relationship and efficacy of AZD9668 at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on lung function and symptoms of COPD.

Enrollment: 838 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of COPD with symptoms over 1 year
• Smokers or ex-smokers
• Males or post-menopausal females between 40 and 80 years old
• Able to use electronic devices

Exclusion criteria

• Past history or current evidence of clinically significant heart disease
• Current diagnosis of asthma
• Patients who require long term oxygen therapy
• Treatment with antibiotics within 4 weeks of study visit 1b

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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838 participants in 4 patient groups, including a placebo group

1

Active Comparator group

Description:

AZD9668 active treatment

Treatment:

Drug: AZD9668

Drug: AZD9668

Drug: AZD9668

2

Active Comparator group

Description:

AZD9668 active treatment

Treatment:

Drug: AZD9668

Drug: AZD9668

Drug: AZD9668

3

Active Comparator group

Description:

AZD9668 active treatment

Treatment:

Drug: AZD9668

Drug: AZD9668

Drug: AZD9668

4

Placebo Comparator group

Description:

AZD9668 placebo treatment

Treatment:

Drug: AZD9668 Placebo