Efficacy of AZD3199 in Chronic Obstructive Pulmonary Disease (COPD) Patients (GLAD)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: COPD

Treatments: Drug: formoterol; Drug: Placebo; Drug: AZD3199

Study type: Interventional

Funder types: Industry

Identifiers

NCT00929708

D0570C00003

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy, safety and tolerability of 4 weeks treatment with AZD3199 in moderate to severe COPD.

Enrollment: 329 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• COPD
• Current or exsmokers, 10 pack years

Exclusion criteria

• Asthma
• Any clinically relevant abnormal findings at screening examinations
• Recent COPD exacerbation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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329 participants in 5 patient groups, including a placebo group

1

Experimental group

Description:

AZD3199 low dose

Treatment:

Drug: AZD3199

2

Experimental group

Description:

AZD3199 intermediate dose

Treatment:

Drug: AZD3199

3

Experimental group

Description:

AZD3199 high dose

Treatment:

Drug: AZD3199

4

Active Comparator group

Description:

Formoterol 2x4.5 microgram bid

Treatment:

Drug: formoterol

5

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo