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AZD9164

Phase 2

Chronic Obstructive Pulmonary Disease | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Aug 5, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment25

FDA Designations

No designations recorded

Clinical trial landscape

AZD9164 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00939211The Study Will Evaluate the Effect of AZD9164 in Patients With Chronic Obstructive Pulmonary DiseaseChronic Obstructive Pulmonary Disease
COMPLETED25 Analytics
PHASE2COMPLETED
The Study Will Evaluate the Effect of AZD9164 in Patients With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
NCT0093921125
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Study Endpoints

Primary Endpoints

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

Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)
up to 48 hours post-dose.

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD9164 100 mcg First, then Placebo for SpririvaEXPERIMENTAL1 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 SpirivaEXPERIMENTAL1 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 SpirivaEXPERIMENTAL1 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 AZD9164ACTIVE_COMPARATOR1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
Placebo for Spiriva First, then Placebo for AZD9164PLACEBO_COMPARATOR1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
1EXPERIMENTALSolution for nebulisation, inhaled
2PLACEBO_COMPARATORSolution for nebulisation, inhaled

Interventions

NameTypeDescription
AZD9164DRUGSolution for inhalation through nebulization, single dose
TiotropiumDRUGDry powder for inhalation, single dose
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

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 disorde...

Countries:Sweden
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Frequently asked questions about AZD9164

What is AZD9164 used for?

AZD9164 is an investigational small molecule being studied for chronic obstructive pulmonary disease (COPD). It has been evaluated in a Phase 2 clinical trial in patients with COPD, as well as in a Phase 1 study in healthy subjects. AZD9164 is not approved and remains in clinical development.

Who makes AZD9164?

AZD9164 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to evaluate the safety and efficacy of AZD9164 in respiratory conditions.

What phase is AZD9164 in?

AZD9164 has completed a Phase 2 clinical trial in patients with chronic obstructive pulmonary disease (COPD). It has also completed a Phase 1 study in healthy subjects. AZD9164 is an investigational drug and is not approved for any use.

What clinical trials is AZD9164 in?

AZD9164 has been studied in two completed trials. NCT00847249 was a Phase 1 single ascending dose study in healthy male subjects in Sweden. NCT00939211 was a Phase 2 trial evaluating the effect of AZD9164 in patients with chronic obstructive pulmonary disease in Sweden.

Is AZD9164 the same as any other drug?

AZD9164 is the primary identifier for this investigational drug developed by AstraZeneca. No alternative names have been reported for AZD9164 in clinical trial records. It is a small molecule being studied for chronic obstructive pulmonary disease.