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)
Overview
- Phase
- Phase 2
- Intervention
- AZD9164
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- AstraZeneca
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
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
Arms & Interventions
AZD9164 100 mcg First, then Placebo for Spririva
1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
Intervention: AZD9164
AZD9164 100 mcg First, then Placebo for Spririva
1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
Intervention: Placebo
AZD9164 400 mcg First, then Placebo for Spiriva
1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
Intervention: AZD9164
AZD9164 400 mcg First, then Placebo for Spiriva
1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
Intervention: Placebo
AZD9164 1200 mcg First, then Placebo for Spiriva
1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
Intervention: AZD9164
AZD9164 1200 mcg First, then Placebo for Spiriva
1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
Intervention: Placebo
Spiriva 18 mcg First, then Placebo for AZD9164
1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
Intervention: Tiotropium
Spiriva 18 mcg First, then Placebo for AZD9164
1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
Intervention: Placebo
Placebo for Spiriva First, then Placebo for AZD9164
1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
Intervention: Placebo
Outcomes
Primary Outcomes
Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose
Time Frame: 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
Time Frame: 22 h, 24 h, 26 h
Trough FEV1 value
Secondary Outcomes
- 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)
- Forced Expiratory Volume in One Second (FEV1), Effect at 15 Minutes Post-dose(15 min)
- Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose(0, 30 min, 2 h, 4 h)
- Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose(0, 30 min, 2 h, 4 h)
- Pulse, Average Effect Over 0 - 4 Hours Post-dose(0, 30 min, 2 h, 4 h)
- Heart Rate, Average Effect Over 0 - 4 Hours Post-dose(0, 30 min, 2 h, 4 h)
- QTcF, Average Effect Over 0 - 4 Hours Post-dose(0, 30 min, 2 h, 4 h)
- 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)
- 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)