Multi-centre study to assess the efficacy and safety of AZD5423 in COPD patients on a background therapy of formoterol

A phase-II, double-blind, placebo-controlled, randomised, parallelgroup, multi-centre study to assess the efficacy and safety of two staggered dose levels of inhaled once daily AZD5423 or twice daily budesonide for 12 weeks in COPD patients on a background therapy of formoterol. - AZD5423 COPD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005389-39-IT

Enrollment

315

Registered

2012-03-05

Start date

2012-03-12

Completion date

Unknown

Last updated

2013-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: AZD5423 Turbuhaler Product Code: AZD5423 Pharmaceutical Form: Inhalation powder INN or Proposed INN: AZD5423 CAS Number: 1034148-04-3 Current Sponsor code: AZD5423 Other descriptive name

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Post-bronchodilator FEV1 =40 and = 80% of the predicted normal value 2. Post-bronchodilator FEV1/FVC =65 years) yes F.1.3.1 Number of subjects for this age range 157

Exclusion criteria

Exclusion criteria: 1.Significant disease or disorder (eg, cardiovascular, pulmonary other than COPD,gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine,metabolic, malignant, psychiatric, major physical impairment) 2.Any clinically relevant abnormal findings in clinical chemistry, haematology, urinalysis, physical examination, pulse, blood pressure or ECG 3.Requirement for long term oxygen therapy 4.An exacerbation of COPD, defined as use of oral or parenteral glucocorticosteroids or oral/parenteral antibiotics or hospitalization related to COPD 5.Participation in or scheduled for an intensive COPD rehabilitation program

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to evaluate the efficacy of inhaled AZD5423 300µg lung deposited dose OD compared with placebo in COPD patients.;Secondary Objective: - To evaluate the efficacy of inhaled AZD5423 75µg lung deposited dose OD versus placebo in COPD patients - To evaluate the efficacy of inhaled AZD5423 compared with budesonide in COPD patients - To evaluate the effect on the HPA-axis of AZD5423 - To evaluate the effect on systemic inflammation - To assess the systemic exposure of AZD5423;Primary end point(s): To evaluate the efficacy of inhaled AZD5423 300µg lung deposited dose OD compared with placebo in COPD patients;Timepoint(s) of evaluation of this end point: At weeks 8 to 12 of randomised treatment	—

Measure

Time frame

Main Objective: The primary objective of the study is to evaluate the efficacy of inhaled AZD5423 300µg lung deposited dose OD compared with placebo in COPD patients.;Secondary Objective: - To evaluate the efficacy of inhaled AZD5423 75µg lung deposited dose OD versus placebo in COPD patients - To evaluate the efficacy of inhaled AZD5423 compared with budesonide in COPD patients - To evaluate the effect on the HPA-axis of AZD5423 - To evaluate the effect on systemic inflammation - To assess the systemic exposure of AZD5423;Primary end point(s): To evaluate the efficacy of inhaled AZD5423 300µg lung deposited dose OD compared with placebo in COPD patients;Timepoint(s) of evaluation of this end point: At weeks 8 to 12 of randomised treatment

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Secondary

Measure	Time frame
Secondary end point(s): - To evaluate the efficacy of inhaled AZD5423 75µg lung deposited dose OD versus placebo in COPD patients - To evaluate the efficacy of inhaled AZD5423 compared with budesonide in COPD patients - To evaluate the effect on the HPA-axis of AZD5423 - To evaluate the effect on systemic inflammation - To assess the systemic exposure of AZD5423;Timepoint(s) of evaluation of this end point: 1. The efficacy of inhaled AZD5423 75µg will be assessed at weeks 2 to 4 of randomised treatment 2. The comparison versus budesonide will be assessed at weeks 8 to 12 of randomised treatment 3. The effect on the HPA -axis and on systemic inflammation will be assessed at week 4 and week 12 4. Systemic exposure will be assessed at week 4 and week 12	—

Measure

Time frame

Secondary end point(s): - To evaluate the efficacy of inhaled AZD5423 75µg lung deposited dose OD versus placebo in COPD patients - To evaluate the efficacy of inhaled AZD5423 compared with budesonide in COPD patients - To evaluate the effect on the HPA-axis of AZD5423 - To evaluate the effect on systemic inflammation - To assess the systemic exposure of AZD5423;Timepoint(s) of evaluation of this end point: 1. The efficacy of inhaled AZD5423 75µg will be assessed at weeks 2 to 4 of randomised treatment 2. The comparison versus budesonide will be assessed at weeks 8 to 12 of randomised treatment 3. The effect on the HPA -axis and on systemic inflammation will be assessed at week 4 and week 12 4. Systemic exposure will be assessed at week 4 and week 12

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Countries

Bulgaria, Hungary, Italy, Russian Federation, Ukraine

Contacts

Public ContactAstraZeneca Clinical Study Informat

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com001 800 2369933

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026