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AZD9164

Phase 2

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

AZD9164 development status

Highest phase Phase 2
Registered trials 3 across 1 sponsor since Feb 2009

AZD9164 target and mechanism

Molecular targetCHRM3
Target classAntagonist
ModalitySmall molecule

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

AZD9164 clinical trials

AZD9164 · 1 trial · 1 indication

Phase 2 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 DiseaseUnlock trial analytics

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

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)

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 being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD), a respiratory condition. It is an investigational small molecule and is not yet approved for any indication. AstraZeneca PLC is the developer.

What does AZD9164 target?

AZD9164 targets CHRM3, the muscarinic acetylcholine receptor M3. It acts as an antagonist at this receptor. By blocking CHRM3, AZD9164 is designed to reduce cholinergic signaling in the airways, which may help alleviate COPD symptoms.

Who is developing AZD9164?

AstraZeneca PLC (ticker: AZN) is developing AZD9164. The company is responsible for the clinical development of this small molecule for COPD.

What phase is AZD9164 in?

AZD9164 is in Phase 2 clinical development. It has not been approved by the FDA or any regulatory agency. The drug remains investigational for the treatment of Chronic Obstructive Pulmonary Disease.

What clinical trials is AZD9164 in?

AZD9164 has been studied in one completed Phase 2 trial, NCT00939211, titled 'The Study Will Evaluate the Effect of AZD9164 in Patients With Chronic Obstructive Pulmonary Disease.' The trial enrolled 25 participants in Sweden and was randomized, double-blind, and placebo-controlled.