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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: March 14, 2012
Last updated: June 14, 2013
Last verified: June 2013
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.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: AZD5423 Drug: Budesonide Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Absolute change from baseline to mean of weeks 8 to 12 in pre-dose forced expiratory volume in 1 sec (FEV1) [ Time Frame: Baseline (week 0), and at week 8, 10, and 12 ]

Secondary Outcome Measures:
  • Percent change from baseline in twenty-four hour plasma cortisol [ Time Frame: Baseline (week 0), and at week 4 and 12 ]
  • Time to first exacerbation (hospitalisation, oral/parenteral corticosteroid, oral/parenteral antibiotics) [ Time Frame: Baseline(week 0) and week 2, 4, 8, 10, 12 and daily by eDairy ]
  • The percent change from baseline in pre-dose hsCRP at week 4 and 12 [ Time Frame: Baseline(week 0), and at week 4 and 12 ]
  • Profile of pharmacokinetics (PK) of AZD5423 in terms of Cmax, tmax, AUC(0-24h), CL/F, Cav in subset of patients [ Time Frame: Week 4 and 12 ]
  • Number of St George's Respiratory Questionnaire (SGRQ-C) responders and Overall Score [ Time Frame: Baseline(week 0), and at week 4 and 12 ]
  • Assessment of Baseline/Transitional Dyspnea Index (BDI/TDI) Score [ Time Frame: Baseline(week 0), and at week 4 and 12 ]
  • Assessment of Breathlessness, Cough and Sputum Scale (BCSS) Score [ Time Frame: Daily by eDairy ]
  • Absolute change from baseline to mean of week 2 and 4 pre-dose forced expiratory volume in 1 sec (FEV1) [ Time Frame: Baseline (week 0), and at week 2 and 4. ]
  • Absolute change from baseline in pre-dose FEV1 [ Time Frame: Baseline (week 0) and at week 2, 4, 8, 10 and 12 ]

Enrollment: 353
Study Start Date: April 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD5423
New study drug
Drug: AZD5423
oral inhaled
Active Comparator: Budesonide
Comparator to which the new study drug will be compared
Drug: Budesonide
oral inhaled
Placebo Comparator: Placebo
No drug to which both other arms will be compared
Drug: Placebo
oral inhaled

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.

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01555099

  Hide Study Locations
Research Site
Doganovo, Bulgaria
Research Site
Plovdiv, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Varna, Bulgaria
Research Site
Brest Cedex 2, France
Research Site
Marseille Cedex 20, France
Research Site
Montpellier, France
Research Site
Nice Cedex 01, France
Research Site
Pessac, France
Research Site
Balassagyarmat, Hungary
Research Site
Budapest, Hungary
Research Site
Deszk, Hungary
Research Site
Szazhalombatta, Hungary
Research Site
Foggia, FG, Italy
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Padova, PD, Italy
Research Site
Verona, VR, Italy
Research Site
Napoli, Italy
Research Site
Pisa, Italy
Research Site
Bialystok, Poland
Research Site
Gorzow Wlkp, Poland
Research Site
Lodz, Poland
Research Site
Proszowice, Poland
Research Site
Tarnow, Poland
Russian Federation
Research Site
Barnaul, Russia, Russian Federation
Research Site
Chelyabinsk, Russian Federation
Research Site
Ekaterinburg, Russian Federation
Research Site
Moscow, Russian Federation
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Novosibirsk, Russian Federation
Research Site
Saint Petersburg, Russian Federation
Research Site
Vladikavkaz, Russian Federation
Research Site
Yaroslavl, Russian Federation
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Bratislava, Slovakia
Research Site
Humenne, Slovakia
Research Site
Kosice, Slovakia
Research Site
Spisska Nova Ves, Slovakia
Research Site
Vrable, Slovakia
Research Site
Zvolen, Slovakia
Research Site
Donetsk, Ukraine
Research Site
Ivano-frankivsk, Ukraine
Research Site
Kharkiv, Ukraine
Research Site
Kyiv, Ukraine
Research Site
Odesa, Ukraine
Research Site
Poltava, Ukraine
Research Site
Zaporizhzhya, Ukraine
Sponsors and Collaborators
Principal Investigator: Piotr Kuna, Professor Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego w Łodzi, ul. Kopcińskiego 22, 90-153, Łódź, Poland
  More Information

Responsible Party: AstraZeneca Identifier: NCT01555099     History of Changes
Other Study ID Numbers: D2340C00011
Study First Received: March 14, 2012
Last Updated: June 14, 2013

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on September 20, 2017