Trial · NCT01509677
Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease
NCT01509677, Phase 3, Completed, AstraZeneca; results first posted 2019-11-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease. Trials, record NCT01509677. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01509677
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease
- NCT number
- NCT01509677
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 158 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Interventions
- Roflumilast, Placebo
- First posted
- 2012-01-13
- Last updated
- 2019-11-29
- Other registries' IDs
- eudract:2011-000582-13
- Results first posted
- 2019-11-29
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | 16 weeks | 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. |
| 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 | 16 weeks | CD4+ Cell Counts in biopsied Material (submucosa):poisson regression model. Clarification: Measure type "Number" refers to "Risk of each treatment group". |
| Secondary | CD45+ Cell Counts in Biopsied Material (Submucosa):Poisson Regression Model | 16 weeks | CD45+ Cell Counts in biopsied Material (submucosa):poisson regression model. Clarification: Measure type "Number" refers to "treatment risk" |
| Secondary | Neutrophils Cell Counts in Biopsied Material (Submucosa):Poisson Regression Model | Baseline to 14 weeks | Neutrophils Cell Counts in biopsied Material (submucosa):poisson regression model. Clarification: Measure type "Number" refers to "Treatment risk" |
| Secondary | CD8+ Cell Count in Biopsied Material (Bronchial Epithelium): Poisson Regression Model | 16 weeks | CD8+ Cell Count in biopsied material (Bronchial Epithelium): poisson regression model. Clarification: Measure Type "Number" refers to "Treatment risk" |
| Secondary | CD68+ Cell Count in Biopsied Material (Bronchial Epithelium):Poisson Regression Model | 16 weeks | CD68+ Cell Count in biopsied material (Bronchial Epithelium):poisson regression model. Clarification: Measure type "Number" refers to "Treatment Risk" |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue. | 16 weeks | The CD8+ cells count results in submucosa for the primary outcome were available for 117 patients at V2 (41 missing) and 114 patients at V6 (44 missing). The reason for missing samples was that the sample amount did not reach the minimal area requested per study protocol. See section 11.4.1 in CSR | CD8+ cells count | MEAN |
| PRIMARY | Change in Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue | Baseline to 16 weeks | The CD8+ cells count results in submucosa for the primary outcome were available for 117 patients at V2 (41 missing) and 114 patients at V6 (44 missing). The reason for missing samples was that the sample amount did not reach the minimal area requested per study protocol. See section 11.4.1 in CSR | cells/mm^2 | MEAN |
| SECONDARY | CD68+ Count in Biopsied Material (Submucosa) | 16 weeks | The reason for missing samples was that the sample amount did not reach the minimal area requested per study protocol. See 11.4.7 in CSR | CD68+ Count | MEAN |
| SECONDARY | CD68+ Cell Count in Biopsied Material (Submucosa): Poisson Regression (Ratio) | 16 weeks | The reason for missing samples was that the sample amount did not reach the minimal area requested per study protocol. See 11.4.7 in CSR | CD68+ Cell Count | NUMBER |
| SECONDARY | Change From V2 to V6 in CD68+ Cell Count (Cells/mm^2) in Biopsied Material (Submucosa) (ITT) | Baseline and 16 weeks | The reason for missing samples was that the sample amount did not reach the minimal area requested per study protocol. See 11.4.7 in CSR | CD68+ Cell Count (cells/mm^2) | LEAST_SQUARES_MEAN |
| SECONDARY | CD4+ Cell Counts in Biopsied Material (Submucosa):Poisson Regression Model | 16 weeks | The reason for missing samples was that the sample amount did not reach the minimal area requested per study protocol. See 11.4.7 in CSR | CD4+ Cell Counts | NUMBER |
| SECONDARY | CD45+ Cell Counts in Biopsied Material (Submucosa):Poisson Regression Model | 16 weeks | The reason for missing samples was that the sample amount did not reach the minimal area requested per study protocol. See 11.4.7 in CSR | CD45+ Cell Counts | NUMBER |
| SECONDARY | Neutrophils Cell Counts in Biopsied Material (Submucosa):Poisson Regression Model | Baseline to 14 weeks | The reason for missing samples was that the sample amount did not reach the minimal area requested per study protocol. See 11.4.7 in CSR | Neutrophils Cell Counts | NUMBER |
| SECONDARY | CD8+ Cell Count in Biopsied Material (Bronchial Epithelium): Poisson Regression Model | 16 weeks | The reason for missing samples was that the sample amount did not reach the minimal area requested per study protocol. See 11.4.7 in CSR | CD8+ Cell Count | NUMBER |
| SECONDARY | CD68+ Cell Count in Biopsied Material (Bronchial Epithelium):Poisson Regression Model | 16 weeks | The reason for missing samples was that the sample amount did not reach the minimal area requested per study protocol. See 11.4.7 in CSR | CD68+ Cell Count | NUMBER |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue. | R500 | 442.4 | Standard Deviation 312.74 | CD8+ cells count | |
| Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue. | Placebo | 427.1 | Standard Deviation 261.42 | CD8+ cells count | |
| Change in Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue | R500 | 13.4 | Standard Deviation 302.69 | cells/mm^2 | |
| Change in Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue | Placebo | 29.4 | Standard Deviation 298.88 | cells/mm^2 | |
| CD68+ Count in Biopsied Material (Submucosa) | R500 | 149.1 | Standard Deviation 113.91 | CD68+ Count | |
| CD68+ Count in Biopsied Material (Submucosa) | Placebo | 124.4 | Standard Deviation 93.15 | CD68+ Count | |
| CD68+ Cell Count in Biopsied Material (Submucosa): Poisson Regression (Ratio) | R500 | 126.8 | NA | CD68+ Cell Count | |
| CD68+ Cell Count in Biopsied Material (Submucosa): Poisson Regression (Ratio) | Placebo | 121.6 | NA | CD68+ Cell Count | |
| Change From V2 to V6 in CD68+ Cell Count (Cells/mm^2) in Biopsied Material (Submucosa) (ITT) | R500 | 6.1 | Standard Error 10.99 | CD68+ Cell Count (cells/mm^2) | |
| Change From V2 to V6 in CD68+ Cell Count (Cells/mm^2) in Biopsied Material (Submucosa) (ITT) | Placebo | -5.3 | Standard Error 11.05 | CD68+ Cell Count (cells/mm^2) |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | R500 | 79 | |
| Overall Study | STARTED | Placebo | 79 | |
| Overall Study | COMPLETED | R500 | 76 | |
| Overall Study | COMPLETED | Placebo | 73 | |
| Overall Study | NOT COMPLETED | R500 | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events102
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | R500 | 11 | 79 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 4 | 79 | 4 |
| other | Dry mouth | Gastrointestinal disorders | R500 | 0 | 79 | 0 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 3 | 79 | 3 |
| other | Nausea | Gastrointestinal disorders | R500 | 6 | 79 | 6 |
| other | Nausea | Gastrointestinal disorders | Placebo | 1 | 79 | 1 |
| other | Vomiting | Gastrointestinal disorders | R500 | 5 | 79 | 5 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 2 | 79 | 2 |
| other | Fatigue | General disorders | R500 | 3 | 79 | 3 |
| other | Fatigue | General disorders | Placebo | 3 | 79 | 3 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | R500 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | R500 | 69 | 79 |
| Total, other adverse events | Placebo | 57 | 79 |
| Total, serious adverse events | R500 | 8 | 79 |
| Total, serious adverse events | Placebo | 5 | 79 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30224319 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| R500 vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01509677
GET https://conductscience.org/api/trials/v1/NCT01509677/registered?page=2