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

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: AZD9164; Drug: Tiotropium; Drug: Placebo

• Registration Number: NCT00939211
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-13
• Study First Submitted QC: 2009-07-13
• Study First Posted: 2009-07-14
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2011-07
• Results First Submitted: 2011-07-08
• Results First Submitted QC: 2011-07-08
• Last Update Submitted: 2011-07-08
• Results First Posted: 2011-08-05
• Last Update Posted: 2011-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AZD9164 100 mcg First, then Placebo for Spririva	AZD9164	1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
AZD9164 100 mcg First, then Placebo for Spririva	Placebo	1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
AZD9164 400 mcg First, then Placebo for Spiriva	AZD9164	1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
AZD9164 400 mcg First, then Placebo for Spiriva	Placebo	1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
AZD9164 1200 mcg First, then Placebo for Spiriva	AZD9164	1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
AZD9164 1200 mcg First, then Placebo for Spiriva	Placebo	1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
Spiriva 18 mcg First, then Placebo for AZD9164	Tiotropium	1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
Spiriva 18 mcg First, then Placebo for AZD9164	Placebo	1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
Placebo for Spiriva First, then Placebo for AZD9164	Placebo	1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)

Primary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose	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	Maximum FEV1 value
Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose	22 h, 24 h, 26 h	Trough FEV1 value

Secondary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post Dose	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	Average FEV1 value
Forced Expiratory Volume in One Second (FEV1), Effect at 15 Minutes Post-dose	15 min	15 min FEV1 value
Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose	0, 30 min, 2 h, 4 h	Average systolic blood pressure value
Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose	0, 30 min, 2 h, 4 h	Average diastolic blood pressure value
Pulse, Average Effect Over 0 - 4 Hours Post-dose	0, 30 min, 2 h, 4 h	Average pulse value
Heart Rate, Average Effect Over 0 - 4 Hours Post-dose	0, 30 min, 2 h, 4 h	Average heart rate value
QTcF, Average Effect Over 0 - 4 Hours Post-dose	0, 30 min, 2 h, 4 h	Average QTcF value
Plasma AZD9164 Cmax	0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h	Maximum plasma concentration of AZD9164
Plasma AZD9164 AUC0-24	0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h	Area under the AZD9164 plasma concentration curve

Trial Locations

Locations (1)

Research Site; 🇸🇪 Lund, Sweden