Clinical trial NCT00939211: The Study Will Evaluate the Effect of AZD9164 in Patients With Chronic Obstructive Pulmonary Disease
Official title: A Double-blind, Double-dummy, Placebo-controlled, Randomised, Multi-centre, 5-way Cross-over, Single-dose Study to Investigate the Local and Systemic Effects of Inhaled AZD9164 Compared to Tiotropium in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
efficacy
safety
inhalation
long-acting muscarinic receptor antagonist (LAMA)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-07-14
Enrollment: 25
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: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose
timeFrame: 0, 15 min, 30 min, 60 min, 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, 15 min, 30 min, 60 min, 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), Effect at 15 Minutes Post-dose
timeFrame: 15 min
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 AZD9164 Cmax
timeFrame: 0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h
measure: Plasma AZD9164 AUC0-24
timeFrame: 0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Research Site
city: Lulea
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
Study officials:
affiliation: University Hospital in Lund, Sweden
name: Leif Bjermer, Prof, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjermer L, Bengtsson T, Jorup C, Lotvall J. Local and systemic effects of inhaled AZD9164 compared with tiotropium in patients with COPD. Respir Med. 2013 Jan;107(1):84-90. doi: 10.1016/j.rmed.2012.09.014. Epub 2012 Oct 23.