Clinical trial NCT01205269: The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
safety
inhalation
long-acting muscarinic receptor antagonist (LAMA)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-20
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed 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)

Eligibility criteria: 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

Primary outcomes:
measure: Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose
timeFrame: 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h
measure: Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose
timeFrame: 22 h, 24 h, 26 h
Secondary outcomes:
measure: Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post-dose
timeFrame: 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h
measure: Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose
timeFrame: 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h
measure: Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose
timeFrame: 0, 30 min, 2 h, 4 h
measure: Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose
timeFrame: 0, 30 min, 2 h, 4 h
measure: Pulse, Average Effect Over 0 - 4 Hours Post-dose
timeFrame: 0, 30 min, 2 h, 4 h
measure: Heart Rate, Average Effect Over 0 - 4 Hours Post-dose
timeFrame: 0, 30 min, 2 h, 4 h
measure: QTcF, Average Effect Over 0 - 4 Hours Post-dose
timeFrame: 0, 30 min, 2 h, 4 h
measure: Plasma AZD8683 Cmax
timeFrame: 0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h
measure: Plasma AZD8683 AUC0-24
timeFrame: 0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Proszowice
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
Study officials:
affiliation: Poland
name: Piotr Kuna, MD Professor
role: PRINCIPAL_INVESTIGATOR
References: