The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Placebo; Drug: AZD8683, 200 mcg; Drug: AZD8683, 50 mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01205269

D1883C00004

EudraCT number: 2010-020506-15

Details and patient eligibility

About

The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in COPD patients.

Full description

A double-blind, placebo-controlled, randomised, multi-centre, 3-way cross-over, single-dose phase II study to investigate the local and systemic effects of inhaled AZD8683 in patients with chronic obstructive pulmonary disease (COPD)

Enrollment: 28 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of COPD
• Current or ex-smokers
• FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post-bronchodilator FEV1/FVC < 70%

Exclusion criteria

• Any clinically significant disease or disorder
• Any clinically relevant abnormal findings at screening examinations
• Family history or presence of glaucoma
• Need of long term oxygen therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

28 participants in 6 patient groups

First 50 mcg, then 200 mcg, then placebo

Experimental group

Description:

period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo

Treatment:

Drug: AZD8683, 200 mcg

Drug: AZD8683, 50 mcg

Drug: Placebo

First 50 mcg, then placebo, then 200 mcg

Experimental group

Description:

period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg

Treatment:

Drug: AZD8683, 200 mcg

Drug: AZD8683, 50 mcg

Drug: Placebo

First 200 mcg, then placebo, then 50 mcg

Experimental group

Description:

period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg

Treatment:

Drug: AZD8683, 200 mcg

Drug: AZD8683, 50 mcg

Drug: Placebo

First 200 mcg, then 50 mcg, then placebo

Experimental group

Description:

period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo

Treatment:

Drug: AZD8683, 200 mcg

Drug: AZD8683, 50 mcg

Drug: Placebo

First placebo, then 200 mcg, then 50 mcg

Experimental group

Description:

period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg

Treatment:

Drug: AZD8683, 200 mcg

Drug: AZD8683, 50 mcg

Drug: Placebo

First placebo, then 50 mcg, then 200 mcg

Experimental group

Description:

period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg

Treatment:

Drug: AZD8683, 200 mcg

Drug: AZD8683, 50 mcg

Drug: Placebo