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AZD1236

Phase 2

Chronic Obstructive Pulmonary Disease | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Apr 16, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment129

FDA Designations

No designations recorded

Clinical trial landscape

AZD1236 · 3 trials · 2 indications

Phase 2 2Phase 1 1
NCT00758459Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) PatientsChronic Obstructive Pulmonary Disease
COMPLETED74 Analytics
NCT00758706A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) PatientsChronic Obstructive Pulmonary Disease
COMPLETED55 Analytics
PHASE2COMPLETED
Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics
PHASE2COMPLETED
A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) Patients
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Adverse Events
all study visits

Number of patients who had an Adverse Event

Ratio of TNF Alpha at Week 6 to Baseline
Baseline and Week 6

Ratio reflects Sputum Tumor Necrosis Factor alpha (TNF alpha) at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).

Ratio of Sputum Total Cells at Week 6 to Baseline
Baseline and Week 6

Ratio reflects Sputum Total Cells at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).

Ratio of Total Urine Desmosine at Week 6 to Baseline
Baseline and Week 6

Ratio reflects Total Urine Desmosine at week 6 value divide by baseline value. Baseline is visit 3(Randomization) value.

Safety and tolerability of AZD1236 by assessment of blood pressure, pulse rate, body temperature, laboratory variables, ECG and adverse events
Assessments taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow up visit. Volunteers will be monitored throughout the study for adverse events.

Secondary Endpoints

Forced Expiratory Volume in 1 Second (FEV1)
Before treatment and after 1, 2, 4 and 6 weeks of treatment
Forced Vital Capacity (FVC)
Before treatment and after 1, 2, 4 and 6 weeks of treatment
Vital Capacity (VC)
Before treatment and after 1, 2, 4 and 6 weeks of treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -
AZD1236EXPERIMENTALoral tablet, 75 mg, twice daily during 6 weeks
PlaceboPLACEBO_COMPARATORDosing to match AZD1236
ActiveEXPERIMENTALAZD1236 tablet
Relative bioavailabilityOTHERAZD1236 Oral suspension
Relative bioavailability tabletOTHERAZD1236 tablet

Interventions

NameTypeDescription
AZD1236DRUGoral tablet, 75 mg, twice daily during 6 weeks
PlaceboDRUGDosing to match AZD1236
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Diagnosis of COPD for 1 month * Men or postmenopausal women * Spirometry values indicating reduced lung function * Smoking history equivalent to using 20 cigarettes a day for 10 years Exclusion Criteria: * Any current respiratory tract disorders other than COPD * Requirement...

Countries:BulgariaFinlandGermanyHungarySlovakiaDenmarkNetherlandsNorwayJapan
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Frequently asked questions about AZD1236

What is AZD1236 used for?

AZD1236 is an investigational small molecule being studied for chronic obstructive pulmonary disease (COPD). It has been evaluated in Phase 2 clinical trials in COPD patients and in a Phase 1 study in healthy volunteers. The drug is being developed by AstraZeneca PLC (AZN).

What does AZD1236 target?

AZD1236 is a small molecule being developed by AstraZeneca for respiratory disease. Its specific molecular target has not been disclosed in the available clinical trial information. The drug has been studied in Phase 2 trials for chronic obstructive pulmonary disease (COPD).

Who makes AZD1236?

AZD1236 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca has sponsored clinical trials of AZD1236 in chronic obstructive pulmonary disease (COPD) and in healthy volunteers.

What phase is AZD1236 in?

AZD1236 is in Phase 2 clinical development for chronic obstructive pulmonary disease (COPD). Two Phase 2 trials in COPD patients have been completed, along with a Phase 1 study in healthy volunteers. AZD1236 is investigational and has not been approved by regulatory authorities.

What clinical trials is AZD1236 in?

AZD1236 has been studied in three completed clinical trials. NCT00758459 was a Phase 2 safety and tolerability study in 74 COPD patients. NCT00758706 was a Phase 2a biomarker study in 55 COPD patients. NCT00767052 was a Phase 1 pharmacokinetic study in 48 healthy male volunteers in Japan.

Is AZD1236 the same as any other drug?

AZD1236 is the code name used for this investigational compound in clinical trials. No alternative brand names or other designations have been reported in the clinical trial information. The drug is being studied under the name AZD1236 by AstraZeneca.