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

Chronic Obstructive Pulmonary Disease Clinical Trial

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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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00939211
• Other study ID #: D1882C00003
• Status: Completed
• Phase: Phase 2
• First received: July 13, 2009
• Last updated: July 8, 2011
• Start date: June 2009
• Est. completion date: November 2009

Study information

• Verified date: July 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• AZD9164
Solution for inhalation through nebulization, single dose
• Tiotropium
Dry powder for inhalation, single dose
• Placebo
Placebo

Locations

Country	Name	City	State
Sweden	Research Site	Gothenburg
Sweden	Research Site	Lulea
Sweden	Research Site	Lund

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose	Maximum FEV1 value	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	No
Primary	Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose	Trough FEV1 value	22 h, 24 h, 26 h	No
Secondary	Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post Dose	Average FEV1 value	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	No
Secondary	Forced Expiratory Volume in One Second (FEV1), Effect at 15 Minutes Post-dose	15 min FEV1 value	15 min	No
Secondary	Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose	Average systolic blood pressure value	0, 30 min, 2 h, 4 h	No
Secondary	Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose	Average diastolic blood pressure value	0, 30 min, 2 h, 4 h	No
Secondary	Pulse, Average Effect Over 0 - 4 Hours Post-dose	Average pulse value	0, 30 min, 2 h, 4 h	No
Secondary	Heart Rate, Average Effect Over 0 - 4 Hours Post-dose	Average heart rate value	0, 30 min, 2 h, 4 h	No
Secondary	QTcF, Average Effect Over 0 - 4 Hours Post-dose	Average QTcF value	0, 30 min, 2 h, 4 h	No
Secondary	Plasma AZD9164 Cmax	Maximum plasma concentration of AZD9164	0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h	No
Secondary	Plasma AZD9164 AUC0-24	Area under the AZD9164 plasma concentration curve	0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h	No