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AZD8683

Phase 2

Chronic Obstructive Pulmonary Disease (COPD) | Small molecule | Respiratory |AstraZeneca PLC|Trials Updated: Mar 19, 2014

AZD8683 development status

Highest phase Phase 2
Registered trials 6 across 1 sponsor since Sep 2009

AZD8683 target and mechanism

Molecular targetCHRM3
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

AZD8683 clinical trials

AZD8683 · 1 trial · 1 indication

Phase 2 1
NCT01205269The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary Disease (COPD)
COMPLETED28 Analytics
PHASE2COMPLETED
The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease (COPD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose
0, 5 min, 15 min, 30 min, 1 h, 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, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h
Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose
0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h
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
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
First 50 mcg, then 200 mcg, then placeboEXPERIMENTALperiod 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo
First 50 mcg, then placebo, then 200 mcgEXPERIMENTALperiod 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg
First 200 mcg, then placebo, then 50 mcgEXPERIMENTALperiod 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg
First 200 mcg, then 50 mcg, then placeboEXPERIMENTALperiod 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo
First placebo, then 200 mcg, then 50 mcgEXPERIMENTALperiod 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg
First placebo, then 50 mcg, then 200 mcgEXPERIMENTALperiod 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg

Interventions

NameTypeDescription
AZD8683, 50 mcgDRUGDry powder for inhalation, single dose
PlaceboDRUGDry powder for inhalation, single dose
AZD8683, 200 mcgDRUGDry powder for inhalation, single dose
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Clinical diagnosis of COPD * Current or ex-smokers * FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post-bronchodilator FEV1/FVC \< 70% Exclusion Criteria: * Any clinically significant disease or disorder * Any clinically relevant abnormal findings at ...

Countries:Poland
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Frequently asked questions about AZD8683

What is AZD8683 used for?

AZD8683 is an investigational inhaled small molecule developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It was studied in a Phase 2 clinical trial in patients with COPD. AZD8683 has not been approved for any indication and remains an investigational therapy in clinical development.

What does AZD8683 target?

AZD8683 targets CHRM3, the muscarinic acetylcholine receptor M3, and acts as an antagonist at this receptor. By blocking CHRM3, the drug is designed to interfere with cholinergic signaling in the airways, a mechanism relevant to the management of Chronic Obstructive Pulmonary Disease (COPD).

Who is developing AZD8683?

AZD8683 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca sponsored the Phase 2 study of AZD8683 in patients with Chronic Obstructive Pulmonary Disease (COPD).

What phase is AZD8683 in?

AZD8683 is in Phase 2 development. It has completed one Phase 2 clinical trial in patients with Chronic Obstructive Pulmonary Disease (COPD). AZD8683 is investigational and has not been approved by the FDA or any other regulatory agency for commercial use.

What clinical trials is AZD8683 in?

AZD8683 has been evaluated in one completed Phase 2 trial, NCT01205269, titled a study to evaluate the effect of AZD8683 in patients with Chronic Obstructive Pulmonary Disease (COPD). The trial enrolled 28 patients in Poland, was randomized, double blind, and controlled, and included participants aged 40 years and older.