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AZD8683

Phase 2

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

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

Clinical trial landscape

AZD8683 · 3 trials · 3 indications

Phase 2 1Phase 1 2
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

Evaluate the safety of AZD8683 by assessing the frequency of adverse events
Adverse events are captured from screening and captured on each clinic day and on the follow up day.
Evaluate the safety of AZD8683 by assessing a panel of laboratory safety assessments
Lab safety assessments are taken at screening, pre-dose on day 1 and then 24 hours, and 48 hours post-dose and again on follow up.
Evaluate the safety of AZD8683 by assessing dECG.
dECG is conducted pre-dose and then 15 minutes, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 4 hours, 8 hours 12 hours, 24 hours and 48 hours post dose.
Evaluate the safety of AZD8683 by assessing physical examination
A physical examination is conducted at screening, day -1, day 3 and again at follow-up.
Evaluate the safety of AZD8683 by assessing vital signs (BP and pulse)
Vital signs are measured at screening, pre-dose and then 15 minutes, 30 minutes, 1 hour, 1 hour 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours and 48 hours post dose
Evaluate the safety of AZD8683 by assessing Spirometry
Spirometry is conducted pre-dose and at 5 minutes, 15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours and 24 hours
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)
Frequent sampling occasions during study days, before and up to 48 h after dosing, and at a follow-up visit 7-13 days after dosing.

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
Group 1 - 4, single ascending dose AZD 8683EXPERIMENTALSubjects will participate in 1 of 4 groups. In each group, 6 subjects will receive AZD8683 and 2 subjects will receive placebo.
Group 1-4 single ascending dose PlaceboPLACEBO_COMPARATORSubjects will participate in 1 of 4 groups. In each group, 6 subjects will receive AZD8683 and 2 subjects will receive placebo.
AEXPERIMENTALAZD8683
BPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
AZD8683, 50 mcgDRUGDry powder for inhalation, single dose
PlaceboDRUGDry powder for inhalation, single dose
AZD8683, 200 mcgDRUGDry powder for inhalation, single dose
AZD8683DRUGSingle Dose Inhaled IMP via Turbuhaler
Placebo to matchDRUGSingle dose Inhaled Placebo via Turbuhaler
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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:PolandUnited KingdomUnited States
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Frequently asked questions about AZD8683

What is AZD8683 used for?

AZD8683 is an investigational small molecule being developed by AstraZeneca for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It has been studied in healthy volunteers and in patients with COPD, with clinical trials assessing its safety, tolerability, pharmacokinetics, and pharmacodynamics.

Who makes AZD8683?

AZD8683 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. The company has conducted clinical trials of AZD8683 in the United States, Poland, and the United Kingdom.

What phase is AZD8683 in?

AZD8683 has completed Phase 1 and Phase 2 clinical trials. The Phase 2 study evaluated the effect of AZD8683 in patients with Chronic Obstructive Pulmonary Disease (COPD). All trials listed for AZD8683 are completed, and the drug remains investigational, not approved by regulatory authorities.

What clinical trials has AZD8683 been in?

AZD8683 has been studied in three completed clinical trials: NCT00979849, a Phase 1 single ascending dose study in healthy volunteers in the United States; NCT01205269, a Phase 2 study in COPD patients in Poland; and NCT01419600, a Phase 1 study of single ascending doses of inhaled AZD8683 in healthy volunteers in the United Kingdom.

Is AZD8683 the same as any other drug?

No alternative names for AZD8683 have been reported. The drug is identified solely by its code name AZD8683 in clinical trial registries and scientific literature. It is not known to be marketed under any other brand name.