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AZD4818

Phase 2

Chronic Obstructive Pulmonary Disease (COPD) | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Dec 6, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment65

FDA Designations

No designations recorded

Clinical trial landscape

AZD4818 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00629239Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary Disease (COPD)
COMPLETED65 Analytics
PHASE2COMPLETED
Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease (COPD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of Patients Experiencing Adverse Events
At all study visits

Number of patients who had an Adverse Event

Incidence and nature of adverse Event, 12-lead ECG, BP, pulse rate, body temperature, spirometry
During the study
Lab assessment
During the study

Secondary Endpoints

Forced Expiratory Volume 1 (FEV1)
Before treatment and after 1, 2, 3 and 4 weeks of treatment
Forced Vital Capacity (FVC)
Before treatment and after 1, 2, 3 and 4 weeks of treatment
Vital Capacity (VC)
Before treatment and after 1, 2, 3 and 4 weeks of treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALAZD4818
2PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
AZD4818DRUGDry Powder, inhalation, b.i.d., 4 weeks
PlaceboDRUG -
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Clinical diagnosis of COPD, with symptoms for more than 1 year * Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year) * Lung function (FEV1) 40 to 80% of the predicted normal value after using a short acting bronchod...

Countries:DenmarkFinlandNetherlandsNorwaySwedenJapan
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Frequently asked questions about AZD4818

What is AZD4818 used for in COPD?

AZD4818 is an investigational small molecule being studied for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD). It is administered via inhalation and has been evaluated in clinical trials for its tolerability, safety, and efficacy in patients with COPD.

Who makes AZD4818?

AZD4818 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in clinical development for respiratory conditions, specifically COPD.

What phase is AZD4818 in?

AZD4818 has completed Phase 2 clinical trials for COPD. It is an investigational drug and has not been approved by regulatory authorities. The development program includes both Phase 1 and Phase 2 studies that have been completed.

What clinical trials is AZD4818 in?

AZD4818 has been studied in two completed clinical trials. NCT00629239 was a Phase 2 study in patients with moderate to severe COPD, enrolling 65 participants across Denmark, Finland, Netherlands, Norway, and Sweden. NCT00687232 was a Phase 1 study in healthy Japanese male volunteers, enrolling 30 participants in Japan.

How does AZD4818 work?

AZD4818 is a small molecule administered by inhalation for the treatment of COPD. The specific molecular target of AZD4818 has not been disclosed in the available clinical trial information, so its exact mechanism of action is not described here.

Is AZD4818 the same as any other drug?

AZD4818 is the primary name used for this investigational drug in clinical trials. No alternative names have been reported in the available clinical trial data, so it is not known to be the same as any other marketed or investigational drug.