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Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT01555099

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

A Phase 2 study testing AZD5423 and Budesonide in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 44 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
AZD5423 and Budesonide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
353 participants
Where
44 sitesin 8 countries
Study dates
Apr 2012to Apr 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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)

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

44 sites in 8 countries.

44 sites in 8 countries

Russia8 sites

  • Research Site

    Barnaul, Russia

  • Research Site

    Chelyabinsk

  • Research Site

    Moscow

  • Research Site

    Novosibirsk

  • Research Site

    Saint Petersburg

  • Research Site

    Vladikavkaz

  • Research Site

    Yaroslavl

  • Research Site

    Yekaterinburg

Other trials in Russia

Ukraine7 sites

  • Research Site

    Donetsk

  • Research Site

    Ivano-Frankivsk

  • Research Site

    Kharkiv

  • Research Site

    Kyiv

  • Research Site

    Odesa

  • Research Site

    Poltava

  • Research Site

    Zaporizhzhya

Other trials in Ukraine

Slovakia6 sites

  • Research Site

    Bratislava

  • Research Site

    Humenné

  • Research Site

    Košice

  • Research Site

    Spišská Nová Ves

  • Research Site

    Vráble, Slovakia

  • Research Site

    Zvolen

Other trials in Slovakia

France5 sites

  • Research Site

    Brest

  • Research Site

    Marseille

  • Research Site

    Montpellier

  • Research Site

    Nice

  • Research Site

    Pessac

Other trials in France

Italy5 sites

  • Research Site

    Foggia, FG

  • Research Site

    Naples

  • Research Site

    Padova, PD

  • Research Site

    Pisa

  • Research Site

    Verona, VR

Other trials in Italy

Poland5 sites

  • Research Site

    Bialystok

  • Research Site

    Gorzow Wlkp

  • Research Site

    Lodz

  • Research Site

    Proszowice

  • Research Site

    Tarnów

Other trials in Poland

Bulgaria4 sites

  • Research Site

    Doganovo

  • Research Site

    Plovdiv

  • Research Site

    Sofia

  • Research Site

    Varna

Other trials in Bulgaria

Hungary4 sites

  • Research Site

    Balassagyarmat

  • Research Site

    Budapest

  • Research Site

    Deszk

  • Research Site

    Százhalombatta

Other trials in Hungary

About this study

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.

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.

Read the 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.

Being tested
AZD5423, Budesonide, Placebo
Keywords
COPD, FEV1, AZD5423
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD5423Drug

    oral inhaled

  • BudesonideDrug

    oral inhaled

  • PlaceboDrug

    oral inhaled

Study groups in NCT01555099
Study groupRoleWhat they receive
AZD5423ExperimentalNew study drug
Receives: Drug: AZD5423
BudesonideActive comparatorComparator to which the new study drug will be compared
Receives: Drug: Budesonide
PlaceboPlacebo comparatorNo drug to which both other arms will be compared
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute change from baseline to mean of weeks 8 to 12 in pre-dose forced expiratory volume in 1 sec (FEV1)

    Measured: Baseline (week 0), and at week 8, 10, and 12

Secondary outcomes (9)

  1. Percent change from baseline in twenty-four hour plasma cortisol

    Measured: Baseline (week 0), and at week 4 and 12

  2. Time to first exacerbation (hospitalisation, oral/parenteral corticosteroid, oral/parenteral antibiotics)

    Measured: Baseline(week 0) and week 2, 4, 8, 10, 12 and daily by eDairy

  3. The percent change from baseline in pre-dose hsCRP at week 4 and 12

    Measured: Baseline(week 0), and at week 4 and 12

  4. Profile of pharmacokinetics (PK) of AZD5423 in terms of Cmax, tmax, AUC(0-24h), CL/F, Cav in subset of patients

    Measured: Week 4 and 12

  5. Number of St George's Respiratory Questionnaire (SGRQ-C) responders and Overall Score

    Measured: Baseline(week 0), and at week 4 and 12

  6. Assessment of Baseline/Transitional Dyspnea Index (BDI/TDI) Score

    Measured: Baseline(week 0), and at week 4 and 12

  7. Assessment of Breathlessness, Cough and Sputum Scale (BCSS) Score

    Measured: Daily by eDairy

  8. Absolute change from baseline to mean of week 2 and 4 pre-dose forced expiratory volume in 1 sec (FEV1)

    Measured: Baseline (week 0), and at week 2 and 4.

  9. Absolute change from baseline in pre-dose FEV1

    Measured: Baseline (week 0) and at week 2, 4, 8, 10 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionApr 2013
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
353 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01555099
Sponsor's protocol ID
D2340C00011
Other IDs
2011-005389-39
Status last verified
Jun 2013
First submitted
14 Mar 2012
Last updated
17 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD5423 and Budesonide in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 44 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in Russia, Ukraine, Slovakia, France, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01555099.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2013.

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