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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 primary aim of this study is to investigate the tolerability and safety of AZD 1236 compared with placebo ("inactive substance") in COPD patients by assessment of Adverse Events, vital signs and laboratory safety assessments.

Safety/tolerability study with AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) patients

oral tablet, 75 mg, twice daily during 6 weeks

Research Site

A 6 Week Double-Blind, Placebo-controlled, Randomised, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of AZD1236as an Oral Tablet in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Number of patients who had an Adverse Event

Age Continuous

Gender, Male/Female

Incidence of adverse events

Change in FEV1  from baseline to end of treatment

Forced expiratory volume in 1 second (FEV1)

Change in FVC from baseline to end of treatment

Forced vital capacity (FVC)

Change in VC from baseline to end of treatment

Vital capacity (VC)

Change in IC from baseline to end of treatment

Inspiratory capacity (IC)

Change in FEF from baseline to end of treatment

Forced expiratory flow (FEF)25−75%

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

Peak expiratory flow (PEF) morning

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

Peak expiratory flow (PEF) evening

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)

Clinical chronic obstructive pulmonary disease (COPD)  Questionnaire(CCQ) total

Change in COPD symptom, Breathlessness  from  average during run-in to average during the last 4 w of treatment.  5-point Likert-type scale, ranging from 0 (none) to 4 (severe)

Clinical chronic obstructive pulmonary disease (COPD) symptoms, Breathlessness

Change in COPD symptom, chest tightness from  average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)

Clinical chronic obstructive pulmonary disease (COPD) symptoms, chest tightness

Change in COPD symptoms, cough score  from  average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)

Clinical chronic obstructive pulmonary disease (COPD) symptoms, Cough score

Change in night time awakenings from  average during run-in to average during the last 4 w of treatment, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe)

Arms	Assigned Interventions
Experimental: 1	Drug: AZD1236 oral tablet, 75 mg, twice daily during 6 weeks
Placebo Comparator: 2	Drug: Placebo Dosing to match AZD1236

Safety/tolerability study with AZD1236 in Chronic Obstructive Pulmonary Disease (COPD) patients - CERA

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=359&filename=CSR-D4260C00003.pdf

CSR-D4260C00003.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator