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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 this study is to study histological changes, cellularity, clinical efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease

14729-D9831C00002- 1 month Biopsy study

Oral tablet, twice daily, 4 weeks treatment

Research Site

A double-blind, placebo-controlled, randomised, parallel group phase IIa study to evaluate the histological changes, cellularity, clinical efficacy and safety of AZD1981 in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD)

Composite endpoint subscores: histological grade, immunohistochemistry grade, leucocyte counts. Change from baseline.

Change in Bronchoalveolar Lavage (BAL): Eosinophil count (%) from baseline

Change in Bronchoalveolar Lavage (BAL): Neutrophil count (%) from baseline

Change in Bronchoalveolar Lavage (BAL): Macrophages count (%) from baseline

Change in Bronchoalveolar Lavage (BAL): Lymphocytes count (%) from baseline

Change in Bronchoalveolar Lavage (BAL): Epithelial cells count (%) from baseline

Change in Bronchoalveolar Lavage (BAL): Total cells count  from baseline

Change in Induced sputum Eosinophil count (%) from baseline

Change in Induced sputum Neutrophils count (%)  from baseline

Change in Induced sputum Macrophages count (%)from baseline

Change in Induced sputum Lymphocytes count (%) from baseline

Change in Induced sputum Epithelial cells count (%) from baseline

Change in Induced sputum Total cells count from baseline

Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to end of treatment

Change in total CCQ score from baseline to last measurement on treatment.  scored on a scale of 0 - 6.   0 =(low symptoms)-6 =(high symptoms)

Mean change in Peak Expiratory Flow (PEF) morning from baseline to the average of the treatment period

Mean change in Peak Expiratory Flow (PEF) evening from baseline to the average of the treatment period

Mean change in COPD symptom night-time awakening score from baseline to the average of the treatment period.  0=(no symptom)-4=(no sleep)

Mean change in COPD symptom breathing score from baseline to the average of the treatment period.   0= (none) - 4 =(severe).

Mean change in COPD symptom cough score from baseline to the average of the treatment period.  0= (none) - 4= (almost constant)

Mean change in COPD symptom sputum score from baseline to the average of the treatment period. 0= (none) - 4= (severe).

Number of participants with an Adverse Event

Arms	Assigned Interventions
Experimental: AZD1981	Drug: AZD1981 Oral tablet, twice daily, 4 weeks treatment
Placebo Comparator: Placebo	Drug: Placebo Placebo

14729-D9831C00002- 1 month Biopsy study - Biopsy

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=216&filename=CSR-D9831C00002.pdf

CSR-D9831C00002.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator