Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A 16-week, Randomized, Placebo-controlled, Double Blind, and Parallel Group Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease
Verified date | November 2019 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of the Biopsy trial is to investigate the effect of roflumilast 500 µg tablets
once daily versus placebo on inflammation parameters in bronchial biopsy tissue specimen and
additional in sputum and blood serum. Also data on safety status will be obtained.
Patients to be included required to have moderate to severe COPD associated with chronic
bronchitis. The total duration of this randomized, multicentre, phase III trial is 24 weeks
maximum.
Status | Completed |
Enrollment | 158 |
Est. completion date | February 1, 2016 |
Est. primary completion date | February 1, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Major Inclusion Criteria: - Giving written informed consent - History of COPD (according to GOLD 2009) for at least 12 months prior to baseline visit V0 associated with chronic productive cough for at least three months in each of the two years prior to baseline visit V0 (with other causes of productive cough excluded) - Outpatients 40-80 years of age - Post-bronchodilator 30% =FEV1 =80% predicted - Post-bronchodilator FEV1/FVC ratio =70% - Current or former smokers with smoking history =20 pack years Main Exclusion Criteria: • Criteria affecting the read-out parameters of the trial: - Clinical instability, defined as experiencing a COPD exacerbation six months prior to V0 - An upper/lower respiratory tract infection which has not resolved four weeks prior to V0 - Diagnosis of asthma and/or other relevant lung disease - Known alpha-1-antitrypsin deficiency - Suspicion or diagnosis of a bleeding disorders irrespective of its pathophysiological mechanism - Other protocol-defined exclusion criteria may apply |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Denmark, Germany, Poland, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue. | 16 weeks | ||
Primary | Change in Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue | Baseline to 16 weeks | ||
Secondary | CD68+ Count in Biopsied Material (Submucosa) | 16 weeks | ||
Secondary | CD68+ Cell Count in Biopsied Material (Submucosa): Poisson Regression (Ratio) | CD68+ Cell Count in Biopsied Material (submucosa): Poisson regression (ratio). Clarification: Measure type described as "Number" refers to "Risk of each treatment group". It is not possible to select "risk" from this template so "number" was selected instead. This issue applies to similar variables reporting poisson regression. | 16 weeks | |
Secondary | Change From V2 to V6 in CD68+ Cell Count (Cells/mm^2) in Biopsied Material (Submucosa) (ITT) | Baseline and 16 weeks | ||
Secondary | CD4+ Cell Counts in Biopsied Material (Submucosa):Poisson Regression Model | CD4+ Cell Counts in biopsied Material (submucosa):poisson regression model. Clarification: Measure type "Number" refers to "Risk of each treatment group". | 16 weeks | |
Secondary | CD45+ Cell Counts in Biopsied Material (Submucosa):Poisson Regression Model | CD45+ Cell Counts in biopsied Material (submucosa):poisson regression model. Clarification: Measure type "Number" refers to "treatment risk" | 16 weeks | |
Secondary | Neutrophils Cell Counts in Biopsied Material (Submucosa):Poisson Regression Model | Neutrophils Cell Counts in biopsied Material (submucosa):poisson regression model. Clarification: Measure type "Number" refers to "Treatment risk" | Baseline to 14 weeks | |
Secondary | CD8+ Cell Count in Biopsied Material (Bronchial Epithelium): Poisson Regression Model | CD8+ Cell Count in biopsied material (Bronchial Epithelium): poisson regression model. Clarification: Measure Type "Number" refers to "Treatment risk" | 16 weeks | |
Secondary | CD68+ Cell Count in Biopsied Material (Bronchial Epithelium):Poisson Regression Model | CD68+ Cell Count in biopsied material (Bronchial Epithelium):poisson regression model. Clarification: Measure type "Number" refers to "Treatment Risk" | 16 weeks | |
Secondary | Change From V1 to V5 in Absolute Cell Count in Induced Sputum (10^6 Neutrophils/mL): Between-Treatment Difference | Baseline to 14 weeks | ||
Secondary | Change From V1 to V5 in Absolute Cell Count inInduced Sputum (10^6 Macrophages/mL): Between-Treatment Difference | Baseline to 14 weeks | ||
Secondary | Change From V1 to V5 in Absolute Cell Count inInduced Sputum (10^6 Eosinophils/mL): Between-Treatment Difference | Baseline to 14 weeks | ||
Secondary | Change From V1 to V5 in Absolute Cell Count inInduced Sputum (10^6 Lymphocytes/mL): Between-Treatment Difference | BAseline to 14 weeks | ||
Secondary | Change From V1 to V5 in Differential Cell Count in Induced Sputum(10^6 Neutrophils/mL) | Baseline to 14 weeks | ||
Secondary | Change From V1 to V5 in Differential Cell Count in Induced Sputum(10^6 Macrophages/mL) | Baseline to 14 weeks | ||
Secondary | Change From V1 to V5 in Differential Cell Count in Induced Sputum(10^6 Eosinophils/mL) | Baseline to 14 weeks | ||
Secondary | Change From V1 to V5 in Differential Cell Count in Induced Sputum(10^6 Lymphocytes)/mL) | Baseline to 14 weeks | ||
Secondary | Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (Alfa- 2-Macroglobulin (µg/mL)) | Baseline to 14 weeks | ||
Secondary | Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (IL-8 (pg/mL)) | Baseline to 14 weeks | ||
Secondary | Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (MMP Type 9 (ng/mL)) | Baseline to 14 weeks | ||
Secondary | Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (MCP-1 (pg/mL)) | Baseline to 14 weeks | ||
Secondary | Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (TIMP-1 (ng/mL)) | Baseline to 14 weeks | ||
Secondary | Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (VEGF (pg/mL)) | Baseline to 14 weeks | ||
Secondary | Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (Alfa-2-Macroglobulin (µg/mL)) | Baseline to 14 weeks | ||
Secondary | Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (IL-8 (pg/mL)) | Baseline to 14 weeks | ||
Secondary | Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (MMP Type 9 (ng/mL)) | Baseline to 14 weeks | ||
Secondary | Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (MCP-1(pg/mL)) | Baseline to 14 weeks | ||
Secondary | Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (TIMP-1(ng/mL)) | Baseline to 14 weeks | ||
Secondary | Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (VEGF(pg/mL)) | Baseline to 14 weeks | ||
Secondary | Change From Baseline in Lung Function Variables: Between-Treatment Differences (FAS) (FEV1 (L)) | Baseline to 16 weeks | ||
Secondary | Change From Baseline in Lung Function Variables: Between-Treatment Differences (FAS) (FVC (L)) | Baseline to 16 weeks | ||
Secondary | Wicoxon Signed-rank Test for Change From V2 to V6 in Post-bronchodilator FEV1/FVC | Wilcoxon test is a non-parametric test to evaluate differences among treatments in the variable that is being reported here. The data reported in the outcome measure data table are hodges Lehmann estimate of change from baseline in FEV1/FVC ratio. | Baseline to 16 weeks |
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