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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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

AZD2423 Safety and Tolerability Study in patients with moderate and severe Chronic Obstructive Pulmonary Disease(COPD)

100 mg oral treatment once daily for 28 days

Research Site

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

Monocyte count in peripheral blood at baseline (Pre-dose, Day 1)

Monocyte count in peripheral blood at end of treatment (4 weeks)

Monocyte count in peripheral blood at follow-up (Week 5; 1 week after end of treatment)

Age Continuous

Gender, Male/Female

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 laboratory variables other than monocytes

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 vital signs

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 ECG variables

Number of participants with clinically significant changes in physical examination assessed at all the listed time points

Number of participants with clinically significant changes in physical examination

Monocytes at baseline

Monocytes at end of treatment

Monocytes at follow-up

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.

Morning FEV1 at baseline

Morning FEV1 during last 7 days of treatment

Measurement conducted by patient in evening.

Evening FEV1 at baseline

Evening FEV1 during last 7 days of treatment

Morning peak expiratory flow (PEF) at baseline

Morning PEF during last 7 days of treatment

Evening PEF at baseline

Evening PEF 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). Baseline is the mean value over the 7 days prior to randomisation.

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).

EXACT 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. Baseline is mean of 10 days prior to treatment.

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.

BCSS (evening) Total score during last 7 days of treatment

Number of inhalations of short acting β2 agonist (SABA) or short acting muscarinic antagonist (SAMA) per day.

Rescue medication use during the last 7 days of treatment

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.

St George’s Respiratory Questionnaire for COPD (SGRQ) Total score at baseline

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.

SGRQ Total score at end of treatment

CCL2 (Chemokine ligand for CCR2b receptor) concentration in plasma at baseline

CCL2 concentration in plasma at end of treatment

Serum Amyloid-A (SAA) concentration in plasma at baseline

SAA concentration in plasma at end of treatment

PK-model: 1-compartment population model with first order absorption. AUC was estimated at steady state

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. Cmaxwas estimated at steady state

Cmax, population pharmacokinetic evaluation of AZD2423 at steady state

PK-model: 1-compartment population model with first order absorption. tmax was estimated at steady state

Time to reach maximum concentration (tmax) 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

Apparent volume of distribution at steady state (Vss/F) population pharmacokinetic evaluation of AZD2423 at steady state

Overall Study

Anna Malmgren

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.

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.

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.

Steady state is the mean of 1, 2 and 4 weeks

Arms	Assigned Interventions
Experimental: AZD2423 AZD2423 Oral Treatment for 28 days	Drug: AZD2423 100 mg oral treatment once daily for 28 days
Placebo Comparator: Placebo Oral treatment for 28 days	Drug: Placebo to AZD2423 Oral treatment once daily for 28 days

AZD2423 Safety and Tolerability Study in patients with moderate and severe Chronic Obstructive Pulmonary Disease(COPD)

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

CSR-D3320C00002.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator