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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

oral tablet, 75 mg, twice daily during 6 weeks

The primary aim of this study is to investigate the effects of AZD1236 compared with placebo ("inactive substance") in COPD patients by analysing biomarkers for inflammation and tissue degradation in blood, urine and sputum.

A phase IIa study assessing the effects of AZD1236 on biomarkers in Chronic Obstructive Pulmonary Disease (COPD) patients

Research Site

A double-blind, randomised, placebo-controlled, parallel group multi-centre Phase IIa study to assess the effects on biomarkers in induced sputum, bood and uine of AZD1236 administered as  oral tablet in  moderate to severe COPD patients during a 6 week period.

Age Continuous

Gender, Male/Female

Ratio reflects Sputum Tumor Necrosis Factor alpha (TNF alpha) at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).

Full analysis set excluded participants without baseline or post-baseline data.

Ratio of TNF alpha at Week 6 to baseline

Ratio reflects Sputum Total Cells at week 6 value divide by baseline value. Baseline is geometric mean of Visit 2 (last value during run-in) and Visit 3 (Randomization).

Ratio of sputum total cells at Week 6 to baseline

Ratio reflects Total Urine Desmosine at week 6 value divide by baseline value. Baseline is visit 3(Randomization) value.

Ratio of Total Urine Desmosine at Week 6 to baseline

Incidence of adverse events

Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value.

Change From Baseline in Forced Expiratory Volume (FEV1) at Week 6

Change From baseline in Forced Vital Capacity (FVC) at Week 6

Change from baseline in Vital Capacity (VC) at Week 6

Change from Baseline in Inspiratory Capacity (IC) at Week 6

Change from Baseline in Forced Expiratory Flow (FEF) 25−75% at Week 6

Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in.

Change from Baseline in Peak Expiratory Flow (PEF) morning at average of last 4 week treatment

Change from Baseline in Peak Expiratory Flow (PEF) evening at average of last 4 week treatment

Change from baseline reflects the Week 6 value minus the baseline value. Baseline is visit 3(randomization) value. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)

Change from Baseline in Clinical COPD Questionnaire(CCQ) total

Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Severe).

Change from Baseline in COPD symptoms, Breathlessness at average of last 4 week treatment

Change from Baseline in COPD symptoms, Chest Tightness at average of last 4 week treatment

Change from baseline reflects the average of last 4 week on treatment (Week 1, Week 2, Week 4 and Week 6) minus the baseline value. Baseline is the mean of the last 10 days of data during run-in. Score vary between 0 (None) to 4 (Almost Constant).

Change from Baseline in COPD symptoms, Cough Score at average of last 4 week treatment

Change from Baseline in COPD symptoms, Night Time Awakenings at average of last 4 week treatment

Overall Study

Gerard Lynch

Change from  average during run-in to average during the last 4 w of treatment

Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)

Arms	Assigned Interventions
Experimental: AZD1236 oral tablet, 75 mg, twice daily during 6 weeks	Drug: AZD1236 oral tablet, 75 mg, twice daily during 6 weeks
Placebo Comparator: Placebo Dosing to match AZD1236	Drug: Placebo Dosing to match AZD1236

A phase IIa study assessing the effects of AZD1236 on biomarkers in Chronic Obstructive Pulmonary Disease (COPD) patients - BICO

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

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=360&filename=CSR-D4260C00007.pdf

D4260C00007

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator