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

Study identifier:D2340C00011

ClinicalTrials.gov identifier:NCT01555099

EudraCT identifier:2011-005389-39

CTIS identifier:N/A

Study Complete

Official Title

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.

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 2

Healthy volunteers

Study drug

AZD5423, Budesonide, Placebo

Sex

All

Actual Enrollment

482

Study type

Interventional

Age

40 Years - 150 Years

Date

Study Start Date: 01 Apr 2012

Primary Completion Date: 01 Apr 2013

Study Completion Date: 01 Apr 2013

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2015 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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
- Able to read and write and use the electronic devices (eDiary and electronic
spirometry)
- Ability to complete an eDiary correctly. Baseline diary data had to be recorded for at least 8 (any 8) of the last 10 days of the run-in period to accept patients for randomized treatment (Randomisation Criteria at Visit 3).
- Provision of informed consent for genetic sampling and analyses. If a patient
declines to participate in the pharmacogenetic research, there will be no
consequence or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in the Clinical Study Protocol (CSP), as long as they consent (Inclusion criteria for patients taking part in the pharmacogenetic research)

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
- Previous randomisation of treatment into the present study
- Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
- Previous allogeneic bone marrow transplant (Exclusion criteria for patients taking part in the pharmacogenetic research)
- Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection (Exclusion criteria for patients taking part in the pharmacogenetic research)

No locations available

Arms	Assigned Interventions
Experimental: AZD5423 New study drug	Drug: AZD5423 oral inhaled Other Name: AZD5423
Active Comparator: Budesonide Comparator to which the new study drug will be compared	Drug: Budesonide oral inhaled Other Name: Budesonide
Placebo Comparator: Placebo No drug to which both other arms will be compared	Drug: Placebo oral inhaled Other Name: Placebo

Documents available

CSR synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

[email protected]

Investigators

Principal Investigator

Piotr Kuna

Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego w Łodzi, ul. Kopcińskiego 22, 90-153, Łódź, Poland