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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01215279
Other study ID # D3320C00002
Secondary ID
Status Completed
Phase Phase 2
First received September 30, 2010
Last updated October 17, 2014
Start date October 2010
Est. completion date March 2011

Study information

Verified date October 2014
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Bulgaria: Bulgarian Drug AgencyBulgaria: Ministry of HealthSlovakia: State Institute for Drug Control
Study type Interventional

Clinical Trial Summary

The purpose of the study is to investigate the tolerability and safety of AZD2423 in Patients with chronic obstructive pulmonary disease.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
AZD2423
100 mg oral treatment once daily for 28 days
Placebo to AZD2423
Oral treatment once daily for 28 days

Locations

Country Name City State
Bulgaria Research Site Russe
Bulgaria Research Site Sofia
Slovakia Research Site Bratislava
Slovakia Research Site Kosice
Slovakia Research Site Presov
Slovakia Research Site Zilina

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Bulgaria,  Slovakia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up) No
Primary 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 Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up) No
Primary 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 Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up) No
Primary 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 Day 1, 1 week, 2 weeks, 3 weeks, 4 weeks and 5 weeks (follow-up) No
Primary Monocytes at Baseline Monocyte count in peripheral blood at baseline (Pre-dose, Day 1) Day 1 No
Primary Monocytes at End of Treatment Monocyte count in peripheral blood at end of treatment (4 weeks) week 4 No
Primary Monocytes at Follow-up Monocyte count in peripheral blood at follow-up (Week 5; 1 week after end of treatment) week 5 (follow-up) No
Secondary 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. Average of 10 days of pre-treatment measurements (day -10 to -1) No
Secondary 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. Average of the last 7 days of treatment (week 4) No
Secondary Evening FEV1 at Baseline Measurement conducted by patient in evening. Average of 10 days of pre-treatment measurements (day -10 to -1) No
Secondary Evening FEV1 During Last 7 Days of Treatment Measurement conducted by patient in evening. Average of the last 7 days of treatment (week 4) No
Secondary 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. Average of 10 days of pre-treatment measurements (day -10 to -1) No
Secondary 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. Average of the last 7 days of treatment (week 4) No
Secondary Evening PEF at Baseline Measurement conducted by patient in evening. Average of 10 days of pre-treatment measurements (day -10 to -1) No
Secondary Evening PEF During Last 7 Days of Treatment Measurement conducted by patient in evening. Average of the last 7 days of treatment (week 4) No
Secondary 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. Average of 7 days of pre-treatment measurements (day -7 to -1) No
Secondary 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). Average of the last 7 days of treatment (week 4) No
Secondary 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. Average of 10 days of pre-treatment measurements (day -10 to -1) No
Secondary 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. Average of the last 7 days of treatment (week 4) No
Secondary Rescue Medication Use During the Last 7 Days of Treatment Number of inhalations of short acting ß2 agonist (SABA) or short acting muscarinic antagonist (SAMA) per day. Average of the last 7 days of treatment (week 4) No
Secondary 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. Day 1 No
Secondary 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. week 4 No
Secondary CCL2 (Chemokine Ligand for CCR2b Receptor) Concentration in Plasma at Baseline Baseline = Day 1 = Visit 2 Day 1 No
Secondary CCL2 Concentration in Plasma at End of Treatment End of treatment = 4 weeks = Visit 6 week 4 No
Secondary Serum Amyloid-A (SAA) Concentration in Plasma at Baseline Baseline = Day 1 = Visit 2 Day 1 No
Secondary SAA Concentration in Plasma at End of Treatment End of treatment = 4 weeks = Visit 6 week 4 No
Secondary 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 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4 No
Secondary Cmax, Population Pharmacokinetic Evaluation of AZD2423 at Steady State PK-model: 1-compartment population model with first order absorption. Cmaxwas estimated at steady state 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4 No
Secondary 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 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4 No
Secondary 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 2 blood samples (pre- and post dose) per visit collected at weeks 1, 2 and 4 No
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