EU Clinical Trial Information System (CTIS)

Brand Logo

Brand Logo Light

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.

I searched for some studies on AstraZeneca Clinical Trials, and found these studies that may also be of interest to you.
Here is the link to my search results

Official Title

The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.

Tolerability/safety and efficacy of inhaled AZD4818 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)

Research Site

A 4-week double-blind, placebo-controlled, randomized, parallel group phase IIa study to assess the tolerability/safety and efficacy of inhaled AZD4818 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)

Number of patients who had an Adverse Event

Age Continuous

Gender, Male/Female

Number of patients experiencing adverse events

Change in (FEV1)  from baseline to end of treatment

Forced Expiratory Volume 1 (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 from IC baseline to end of treatment

Inspiratory Capacity (IC)

Change in FEF from baseline to end of treatment

Forced Expiratory Flow (FEF) 25%-75%

Change from  average during run-in to average during treatment

Peak Expiratory Flow (PEF) morning

Change in PEF from  average during run-in to average during 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)

The Clinical COPD ( Chronic obstructive pulmonary disease) Questionnaire (CCQ) total

Change from  average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).

Chronic Obstructive Pulmonary Disease (COPD) symptoms, Breathlessness

Chronic Obstructive Pulmonary Disease (COPD) symptoms, chest tightness

Change from  average during run-in to average during treatment.  Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).

Chronic Obstructive Pulmonary Disease (COPD)  symptoms, Cough score

Change from  average during run-in to average during treatmentScores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).

Arms	Assigned Interventions
Experimental: 1 AZD4818	Drug: AZD4818 Dry Powder, inhalation, b.i.d., 4 weeks
Placebo Comparator: 2 Placebo	-

Tolerability/safety and efficacy of inhaled AZD4818 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) - TOP

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=316&filename=CSR-D3540C00005.pdf

CSR-D3540C00005.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator