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AZD1236

Phase 2

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment129
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00758459Safety/Tolerability Study With AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) PatientsPHASE2 COMPLETED 74Sep 1, 2008Mar 1, 2009Aug 19, 201114 Bulgaria, Finland +3
NCT00758706A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) PatientsPHASE2 COMPLETED 55Sep 1, 2008May 1, 2009Apr 16, 201510 Denmark, Finland +2
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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.

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
Interventions
NameTypeDescription
AZD1236DRUGoral tablet, 75 mg, twice daily during 6 weeks
PlaceboDRUGDosing to match AZD1236
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Eligibility Criteria
Age Range40 Years — 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:BulgariaFinlandGermanyHungarySlovakiaDenmarkNetherlandsNorway
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