Chronic Obstructive Pulmonary DiseasePhase 2NCT01215279
AZD2423 Safety and Tolerability Study in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease(COPD)
A Phase 2 study testing AZD2423 in people with Chronic Obstructive Pulmonary Disease and Lung Disease, run by AstraZeneca at 6 sites in 2 countries.
Trial summary
The purpose of the study is to investigate the tolerability and safety of AZD2423 in Patients with chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Lung Disease
- What is being tested?
- AZD2423
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Oct 2010to Mar 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female of non-child bearing potential. Only women of non-child bearing potential are included in the study i.e. women who are permanently or surgically sterilised or post menopausal.
- Between 40 and 80 years of age at Visit 1
- Clinical diagnosis of COPD (GOLD stage 2 or 3)
- FEV1/FVC <70% and FEV1 between 30 and 80% of the predicted normal post-bronchodilator (GOLD stage 2 or 3)
- Current or ex-smokers
Who cannot join
- Any clinically significant disease or disorder (including history of abnormal immune function) which, in the opinion of the Investigator, may either put the subject at risk or influence the way the drug works
- Any lung disease other than COPD, recent respiratory infections which have not resolved fully, active tuberculosis or at risk of reactivation of tuberculosis.
- Any abnormal findings in physical examination, blood or urine test results, vital signs or ECG at Visit 1 that may put the subject at risk during the study, affect their ability to take part or influence the results of the study
- Immunisation with a live vaccine within 3 months or other vaccination within 30 days before planned start of treatment
- Worsening of COPD symptoms within 4 weeks prior to start of study needing hospitalisation, oral steroids or antibiotics.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Slovakia4 sites
Research Site
Bratislava
Research Site
Košice
Research Site
Prešov
Research Site
Žilina
About this study
Official title: A 4-week, Double-Blind, Placebo-Controlled, Randomised, Parallel Group, Multi-Centre, Phase IIa Study to Investigate the Tolerability and Safety of 100 mg Oral AZD2423 in Patients With Moderate to Severe COPD
The purpose of the study is to investigate the tolerability and safety of AZD2423 in Patients with chronic obstructive pulmonary disease.
- Being tested
- AZD2423, Placebo to AZD2423
- Keywords
- Respiratory disease, Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2423Drug
100 mg oral treatment once daily for 28 days
Placebo to AZD2423Drug
Oral treatment once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| AZD2423 | Experimental | AZD2423 Oral Treatment for 28 days Receives: Drug: AZD2423 |
| Placebo | Placebo comparator | Oral treatment for 28 days Receives: Drug: Placebo to AZD2423 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinically Significant Changes in Laboratory Variables Other Than Monocytes
Number of all participants with clinically significant changes in laboratory variables, except monocyte, assessed at all the listed time points
Measured: Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)
Number of Participants With Clinically Significant Changes in Vital Signs
Number of participants with clinically significant changes in vital signs assessed at all the listed time points
Measured: Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)
Number of Participants With Clinically Significant Changes in ECG Variables
Number of participants with clinically significant changes in ECG variables assessed at all the listed time points
Measured: Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)
Number of Participants With Clinically Significant Changes in Physical Examination
Number of participants with clinically significant changes in physical examination assessed at all the listed time points
Measured: Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)
Monocytes at Baseline
Monocyte count in peripheral blood at baseline (Pre-dose, Day 1)
Measured: Day 1
Monocytes at End of Treatment
Monocyte count in peripheral blood at end of treatment (4 weeks)
Measured: week 4
Monocytes at Follow-up
Monocyte count in peripheral blood at follow-up (Week 5; 1 week after end of treatment)
Measured: week 5 (follow-up)
Secondary outcomes (23)
Morning FEV1 at Baseline
Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.
Measured: Average of 10 days of pre-treatment measurements (day -10 to -1)
Morning FEV1 During Last 7 Days of Treatment
Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.
Measured: Average of the last 7 days of treatment (week 4)
Evening FEV1 at Baseline
Measurement conducted by patient in evening.
Measured: Average of 10 days of pre-treatment measurements (day -10 to -1)
Evening FEV1 During Last 7 Days of Treatment
Measurement conducted by patient in evening.
Measured: Average of the last 7 days of treatment (week 4)
Morning Peak Expiratory Flow (PEF) at Baseline
Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.
Measured: Average of 10 days of pre-treatment measurements (day -10 to -1)
Morning PEF During Last 7 Days of Treatment
Measurements conducted by patient in morning upon rising, before intake of morning dose of investigational product but after clearing out mucus. Patients was to refrain from taking rescue medication prior to measurement if possible.
Measured: Average of the last 7 days of treatment (week 4)
Evening PEF at Baseline
Measurement conducted by patient in evening.
Measured: Average of 10 days of pre-treatment measurements (day -10 to -1)
Evening PEF During Last 7 Days of Treatment
Measurement conducted by patient in evening.
Measured: Average of the last 7 days of treatment (week 4)
Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score at Baseline
The EXACT Tool is a Patient Reported Outcome (PRO) measure; 14 items evaluated on 5- or 6-point scales; total score ranges from 0 to 100 (higher values indicate more severe exacerbation). Baseline is the mean value over the 7 days prior to randomisation.
Measured: Average of 7 days of pre-treatment measurements (day -7 to -1)
EXACT Total Score During Last 7 Days of Treatment
The EXACT Tool is a Patient Reported Outcome (PRO) measure; 14 items evaluated on 5- or 6-point scales; total score ranges from 0 to 100 (higher values indicate more severe exacerbation).
Measured: Average of the last 7 days of treatment (week 4)
Breathlessness, Cough and Sputum Scale (BCSS) (Evening) Total Score at Baseline
The BCSS scale includes one question for each of the symptoms of breathlessness, cough, and sputum. The total BCSS score ranges from 0 to 12; higher scores indicate greater symptom severity. The minimally important difference has been defined as a change in total score of greater than 0.3 units. Baseline is mean of 10 days prior to treatment.
Measured: Average of 10 days of pre-treatment measurements (day -10 to -1)
BCSS (Evening) Total Score During Last 7 Days of Treatment
The BCSS scale includes one question for each of the symptoms of breathlessness, cough, and sputum. The total BCSS score ranges from 0 to 12; higher scores indicate greater symptom severity. The minimally important difference has been defined as a change in total score of greater than 0.3 units.
Measured: Average of the last 7 days of treatment (week 4)
Rescue Medication Use During the Last 7 Days of Treatment
Number of inhalations of short acting β2 agonist (SABA) or short acting muscarinic antagonist (SAMA) per day.
Measured: Average of the last 7 days of treatment (week 4)
St George's Respiratory Questionnaire for COPD (SGRQ) Total Score at Baseline
The SGRQ-C includes 40 questions in 3 domains: Symptoms (distress due to respiratory symptoms, 7 questions), Activity (disturbance of physical activity, 13 questions), Impacts (overall impact on daily life and well-being, 20 questions). Scores are expressed as a percentage. Baseline is Day 1.
Measured: Day 1
SGRQ Total Score at End of Treatment
Decrease in score represents improved Quality of Life; increase represents deteriorated Quality of Life. An increase or decrease of 4 or more percent units is judged as the Minimal Clinically Important Difference.
Measured: week 4
CCL2 (Chemokine Ligand for CCR2b Receptor) Concentration in Plasma at Baseline
Baseline = Day 1 = Visit 2
Measured: Day 1
CCL2 Concentration in Plasma at End of Treatment
End of treatment = 4 weeks = Visit 6
Measured: week 4
Serum Amyloid-A (SAA) Concentration in Plasma at Baseline
Baseline = Day 1 = Visit 2
Measured: Day 1
SAA Concentration in Plasma at End of Treatment
End of treatment = 4 weeks = Visit 6
Measured: week 4
Areaa Under the Curve From 0 to 24 Hours (AUC 0-24), Population Pharmacokinetic Evaluation of AZD2423 at Steady State
PK-model: 1-compartment population model with first order absorption. AUC was estimated at steady state
Measured: 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4
Cmax, Population Pharmacokinetic Evaluation of AZD2423 at Steady State
PK-model: 1-compartment population model with first order absorption. Cmaxwas estimated at steady state
Measured: 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4
Time to Reach Maximum Concentration (Tmax) Population Pharmacokinetic Evaluation of AZD2423 at Steady State
PK-model: 1-compartment population model with first order absorption. tmax was estimated at steady state
Measured: 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4
Apparent Volume of Distribution at Steady State (Vss/F) Population Pharmacokinetic Evaluation of AZD2423 at Steady State
PK-model: 1-compartment population model with first order absorption. (Vss/F) was estimated at steady state
Measured: 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanna Marks-Konczalik, MD, PhD, Study director, AstraZeneca R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215279
- Sponsor's protocol ID
- D3320C00002
- Status last verified
- Oct 2014
- First submitted
- 30 Sep 2010
- Last updated
- 23 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-week, Double-Blind, Placebo-Controlled, Randomised, Parallel Group, Multi-Centre, Phase IIa Study to Investigate the Tolerability and Safety of 100 mg Oral AZD2423 in Patients With Moderate to Severe COPD
- ClinicalTrials.gov ID
- NCT01215279
- Acronym / sponsor ID
- D3320C00002
- Keywords
- Respiratory disease, Chronic Obstructive Pulmonary Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 6 Oct 2010 (estimated)
- Results
- Posted 23 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate the tolerability and safety of AZD2423 in Patients with chronic obstructive pulmonary disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD2423 | Experimental | Drug: AZD2423AZD2423 Oral Treatment for 28 days |
| Placebo | Placebo comparator | Drug: Placebo to AZD2423Oral treatment for 28 days |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female of non-child bearing potential. Only women of non-child bearing potential are included in the study i.e. women who are permanently or surgically sterilised or post menopausal.
- Between 40 and 80 years of age at Visit 1
- Clinical diagnosis of COPD (GOLD stage 2 or 3)
- FEV1/FVC <70% and FEV1 between 30 and 80% of the predicted normal post-bronchodilator (GOLD stage 2 or 3)
- Current or ex-smokers
Key exclusion criteria (5 listed)
- Any clinically significant disease or disorder (including history of abnormal immune function) which, in the opinion of the Investigator, may either put the subject at risk or influence the way the drug works
- Any lung disease other than COPD, recent respiratory infections which have not resolved fully, active tuberculosis or at risk of reactivation of tuberculosis.
- Any abnormal findings in physical examination, blood or urine test results, vital signs or ECG at Visit 1 that may put the subject at risk during the study, affect their ability to take part or influence the results of the study
- Immunisation with a live vaccine within 3 months or other vaccination within 30 days before planned start of treatment
- Worsening of COPD symptoms within 4 weeks prior to start of study needing hospitalisation, oral steroids or antibiotics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD2423100 mg oral treatment once daily for 28 days | Drug | AZD2423 |
| Placebo to AZD2423Oral treatment once daily for 28 days | Drug | Placebo |
Primary outcome
Number of Participants With Clinically Significant Changes in Laboratory Variables Other Than Monocytes
Time frame: Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)
Number of all participants with clinically significant changes in laboratory variables, except monocyte, assessed at all the listed time points
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)
Number of participants with clinically significant changes in vital signs assessed at all the listed time points
Number of Participants With Clinically Significant Changes in ECG Variables
Time frame: Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)
Number of participants with clinically significant changes in ECG variables assessed at all the listed time points
Number of Participants With Clinically Significant Changes in Physical Examination
Time frame: Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)
Number of participants with clinically significant changes in physical examination assessed at all the listed time points
Monocytes at Baseline
Time frame: Day 1
Monocyte count in peripheral blood at baseline (Pre-dose, Day 1)
Monocytes at End of Treatment
Time frame: week 4
Monocyte count in peripheral blood at end of treatment (4 weeks)
Monocytes at Follow-up
Time frame: week 5 (follow-up)
Monocyte count in peripheral blood at follow-up (Week 5; 1 week after end of treatment)
23 secondary outcomes
Morning FEV1 at Baseline
Time frame: Average of 10 days of pre-treatment measurements (day -10 to -1)
Morning FEV1 During Last 7 Days of Treatment
Time frame: Average of the last 7 days of treatment (week 4)
Evening FEV1 at Baseline
Time frame: Average of 10 days of pre-treatment measurements (day -10 to -1)
Evening FEV1 During Last 7 Days of Treatment
Time frame: Average of the last 7 days of treatment (week 4)
Morning Peak Expiratory Flow (PEF) at Baseline
Time frame: Average of 10 days of pre-treatment measurements (day -10 to -1)
Morning PEF During Last 7 Days of Treatment
Time frame: Average of the last 7 days of treatment (week 4)
Evening PEF at Baseline
Time frame: Average of 10 days of pre-treatment measurements (day -10 to -1)
Evening PEF During Last 7 Days of Treatment
Time frame: Average of the last 7 days of treatment (week 4)
Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score at Baseline
Time frame: Average of 7 days of pre-treatment measurements (day -7 to -1)
EXACT Total Score During Last 7 Days of Treatment
Time frame: Average of the last 7 days of treatment (week 4)
Breathlessness, Cough and Sputum Scale (BCSS) (Evening) Total Score at Baseline
Time frame: Average of 10 days of pre-treatment measurements (day -10 to -1)
BCSS (Evening) Total Score During Last 7 Days of Treatment
Time frame: Average of the last 7 days of treatment (week 4)
Rescue Medication Use During the Last 7 Days of Treatment
Time frame: Average of the last 7 days of treatment (week 4)
St George's Respiratory Questionnaire for COPD (SGRQ) Total Score at Baseline
Time frame: Day 1
SGRQ Total Score at End of Treatment
Time frame: week 4
CCL2 (Chemokine Ligand for CCR2b Receptor) Concentration in Plasma at Baseline
Time frame: Day 1
CCL2 Concentration in Plasma at End of Treatment
Time frame: week 4
Serum Amyloid-A (SAA) Concentration in Plasma at Baseline
Time frame: Day 1
SAA Concentration in Plasma at End of Treatment
Time frame: week 4
Areaa Under the Curve From 0 to 24 Hours (AUC 0-24), Population Pharmacokinetic Evaluation of AZD2423 at Steady State
Time frame: 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4
Cmax, Population Pharmacokinetic Evaluation of AZD2423 at Steady State
Time frame: 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4
Time to Reach Maximum Concentration (Tmax) Population Pharmacokinetic Evaluation of AZD2423 at Steady State
Time frame: 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4
Apparent Volume of Distribution at Steady State (Vss/F) Population Pharmacokinetic Evaluation of AZD2423 at Steady State
Time frame: 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- CSR-D3320C00002.pdfLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna Marks-Konczalik, MD, PhD study director
AstraZeneca R&D
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD2423 in people with Chronic Obstructive Pulmonary Disease and Lung Disease, run by AstraZeneca at 6 sites in 2 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 5 inclusion and 5 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 23 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Slovakia, Bulgaria. 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?
Yes. Results are posted in the registry (first posted 23 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Clinically Significant Changes in Laboratory Variables Other Than Monocytes (time frame: Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2014.