Loading clinical trials...

Multi-centre Study to Assess the Efficacy and Safety of AZD5423 in COPD Patients on a Background Therapy of Formoterol | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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, Parallel-group,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.

NCT01555099•AstraZeneca

View on ClinicalTrials.gov

Summary

The purpose of the study is 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.

Detailed Description

A phase-II, double-blind, placebo-controlled, randomised, parallel-group,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.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Provision of signed and dated informed consent prior to conducting any study specific procedures
•Men or women aged ≥ 40 years
•Men or post-menopausal or surgically sterile women. Women will be considered post-menopausal if they have been amenorrheic for at least 12 months, and have a follicle stimulating hormone (FSH) plasma concentration within the postmenopausal range as defined by the laboratory. Male patients should be willing to use barrier contraception, i.e. condom (with spermicide) from the day of dosing until at least 5 weeks after the last dose with the study drug.
•Clinical diagnosis of COPD for more than 1 year at Visit 1, according to GOLD guidelines
•Current maintenance therapy with LABA and/or LAMA, ICS/LABA or ICS plus LAMA combination
•Current or ex-smokers with a smoking history equivalent to at least 10 pack years (1 pack year = 20 cigarettes smoked per day for one year)
•Post-bronchodilator FEV1 ≥40 and ≤ 80% of the predicted normal value
•Post-bronchodilator FEV1/FVC \<0,7
•Reversibility of airway obstruction according to reversibility test performed at visit 2, defined as an increase in FEV1 of ≥10% relative baseline after inhalation of in total 400 μg salbutamol or 1 mg terbutaline sulphate
•Chest radiography (not older than 12 months at Visit 2) not showing any pathological changes that would make the patient unsuitable for inclusion as judged by the Investigator
+2 more criteria

Exclusion Criteria

•Significant disease or disorder (eg, cardiovascular, pulmonary other than COPD, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study
•Any clinically relevant abnormal findings in clinical chemistry, haematology, urinalysis, physical examination, pulse, blood pressure or ECG at Visit 2, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study
•Requirement for long term oxygen therapy
•An exacerbation of COPD, defined as use of oral or parenteral glucocorticosteroids or oral/parenteral antibiotics or hospitalisation related to COPD within 6 weeks of Visit 2
•Participation in or scheduled for an intensive COPD rehabilitation program
•Known or suspected hypersensitivity to study therapy or excipients of the study drug
•History of current alcohol or drug abuse or any condition associated with poor compliance as judged by the investigator
•Plasma donation within one month of screening or any blood donation/blood loss \>500 mL during the 3 months prior to screening.
•Participation in any clinical study with an investigational drug or new formulation of a marketed drug in the 3 months prior to Visit 2
•Planned in-patient surgery or hospitalisation during the study
+2 more criteria

Locations (44)

Research Site

Doganovo, Bulgaria

Research Site

Plovdiv, Bulgaria

Research Site

Sofia, Bulgaria

Research Site

Varna, Bulgaria

Research Site

Brest, France

Research Site

Marseille, France

Research Site

Montpellier, France

Research Site

Nice, France

Research Site

Pessac, France

Research Site

Balassagyarmat, Hungary

Key Dates

Start Date

April 1, 2012

Primary Completion Date

April 1, 2013

Completion Date

April 1, 2013

Last Updated

June 17, 2013

Enrollment

353

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

AZD5423

DRUG

Budesonide

DRUG

Placebo

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

View study

RECRUITINGNA

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

NCT07382258

Chronic Obstructive Pulmonary Disease (COPD)

View study

RECRUITINGNA

Mindful-Breath for People With COPD

NCT07195838

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 17, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Multi-centre Study to Assess the Efficacy and Safety of AZD5423 in COPD Patients on a Background Therapy of Formoterol

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

Mindful-Breath for People With COPD

The HELlenic Thoracic Society Initiative for CΟPD and CVD

Magnetic Stimulation of Diaphragm in Chronic Obstructive Pulmonary Disease

COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A