The Study Will Evaluate the Effect of AZD9164 in Patients With Chronic Obstructive Pulmonary Disease (LaCrossE)

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: AZD9164; Drug: Placebo; Drug: Tiotropium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00939211

D1882C00003

Details and patient eligibility

About

Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory condition with deteriorating lung function over the years. Patients with COPD experience symptoms of shortness of breath, cough and sputum production. This study is to assess the treatment effects after inhalation of three different single doses of AZD9164 (100, 400 and 1200 mcg) and one single dose of tiotropium (18 mcg). One dose of placebo will be given as comparator. 25 patients are to participate in the study and all will be recruited in Sweden. Each patient will visit the study doctor 9 times during the study, whereof 5 visits will be overnight visits. All examinations, treatment and the follow-up is free of charge.

Enrollment: 25 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A clinical diagnosis of COPD
• FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post- bronchodilator FEV1/FVC < 70%

Exclusion criteria

• Any clinically relevant abnormal findings at screening examinations
• Any clinically significant disease or disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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25 participants in 5 patient groups, including a placebo group

AZD9164 100 mcg First, then Placebo for Spririva

Experimental group

Description:

1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation

Treatment:

Drug: AZD9164

Drug: Placebo

AZD9164 400 mcg First, then Placebo for Spiriva

Experimental group

Description:

1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation

Treatment:

Drug: AZD9164

Drug: Placebo

AZD9164 1200 mcg First, then Placebo for Spiriva

Experimental group

Description:

1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation

Treatment:

Drug: AZD9164

Drug: Placebo

Spiriva 18 mcg First, then Placebo for AZD9164

Active Comparator group

Description:

1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)

Treatment:

Drug: Tiotropium

Drug: Placebo

Placebo for Spiriva First, then Placebo for AZD9164

Placebo Comparator group

Description:

1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)

Treatment:

Drug: Placebo