COPDPhase 3NCT01509677
Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease
A Phase 3 study testing Roflumilast in people with COPD and Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 20 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Roflumilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 20 sitesin 5 countries
- Study dates
- 1 Feb 2012to 1 Feb 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
Germany7 sites
Study site
Freiburg im Breisgau
Study site
Großhansdorf
Study site
Hanover
Study site
Heidelberg
Study site
Immenhausen
Study site
Kiel
Study site
Mainz
United Kingdom6 sites
Study site
Cottingham
Study site
Dafen
Study site
Leicester
Study site
London
Study site
Manchester
Study site
Norwich, NR4 7UY
Poland4 sites
Study site
Bialystok
Study site
Krakow
Study site
Lodz, 90-153
Study site
Lodz
About this study
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
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.
Read the detailed description
This was a multicenter, double-blind, randomized, parallel group, phase 3 study. Patients included had a history of COPD (GOLD stage II-III, in Germany stage II only) with chronic productive cough.
There were 2 parallel treatment arms (placebo and roflumilast 500 μg once daily). A 1 to 1 randomization scheme was used, that is, patients were allocated to roflumilast 500 μg or placebo in equal proportions. Randomization was stratified by concomitant LABA use.
The total duration of this study was 24 weeks maximum per patient. The study consisted of the following periods:
- Single-blind placebo run-in period (6 weeks) with visits at Week -6 (visit 0 [V0]), Week -2 (V1), and Week 0 (V2, randomization visit), during which all patients received placebo.
- Double-blind treatment period (16 weeks) during which patients received either roflumilast or matching placebo with visits at Week 6 (V4), Week 14 (V5), and Week 16 (V6).
An additional visit (V3) within 2 weeks after bronchoscopy/bronchial biopsy was performed purely as a safety visit. The exact timing of this safety visit was to be determined by the investigator. Safety follow-up. All AEs were followed up to 30 days after the double-blind treatment period. An additional safety visit, V7, was scheduled within 2 weeks after the second bronchoscopy. The exact timing of the safety visit was to be determined by the investigator.
Patients were required not to take any food or drink overnight for at least 8 hours prior to returning to the study center for each visit. Patients were also asked to avoid strenuous exercise for 8 hours prior to each study visit and to avoid smoking for 4 hours prior to each study visit.
For visits where patients did not undergo blood collections or biopsies, the fasting requirement was only mandated if clinically indicated, per investigator judgment.
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Being tested
- Roflumilast, Placebo
- Keywords
- Roflumilast, Chronic Obstructive Pulmonary Disease, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoflumilastDrug
Also called Daxas
500 μg tablet, once daily, oral administration in the morning after breakfast
PlaceboDrug
Also called Placebo to Roflumilast
tablet, once daily, oral administration in the morning after breakfast
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast | Active comparator | 500 μg tablet, once daily, oral administration in the morning after breakfast Receives: Drug: Roflumilast |
| Placebo | Placebo comparator | tablet, once daily, oral administration in the morning after breakfast Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue.
Measured: 16 weeks
Change in Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue
Measured: Baseline to 16 weeks
Secondary outcomes (31)
CD68+ Count in Biopsied Material (Submucosa)
Measured: 16 weeks
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.
Measured: 16 weeks
Change From V2 to V6 in CD68+ Cell Count (Cells/mm^2) in Biopsied Material (Submucosa) (ITT)
Measured: Baseline and 16 weeks
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".
Measured: 16 weeks
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"
Measured: 16 weeks
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"
Measured: Baseline to 14 weeks
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"
Measured: 16 weeks
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"
Measured: 16 weeks
Change From V1 to V5 in Absolute Cell Count in Induced Sputum (10^6 Neutrophils/mL): Between-Treatment Difference
Measured: Baseline to 14 weeks
Change From V1 to V5 in Absolute Cell Count inInduced Sputum (10^6 Macrophages/mL): Between-Treatment Difference
Measured: Baseline to 14 weeks
Change From V1 to V5 in Absolute Cell Count inInduced Sputum (10^6 Eosinophils/mL): Between-Treatment Difference
Measured: Baseline to 14 weeks
Change From V1 to V5 in Absolute Cell Count inInduced Sputum (10^6 Lymphocytes/mL): Between-Treatment Difference
Measured: BAseline to 14 weeks
Change From V1 to V5 in Differential Cell Count in Induced Sputum(10^6 Neutrophils/mL)
Measured: Baseline to 14 weeks
Change From V1 to V5 in Differential Cell Count in Induced Sputum(10^6 Macrophages/mL)
Measured: Baseline to 14 weeks
Change From V1 to V5 in Differential Cell Count in Induced Sputum(10^6 Eosinophils/mL)
Measured: Baseline to 14 weeks
Change From V1 to V5 in Differential Cell Count in Induced Sputum(10^6 Lymphocytes)/mL)
Measured: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (Alfa- 2-Macroglobulin (µg/mL))
Measured: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (IL-8 (pg/mL))
Measured: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (MMP Type 9 (ng/mL))
Measured: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (MCP-1 (pg/mL))
Measured: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (TIMP-1 (ng/mL))
Measured: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (VEGF (pg/mL))
Measured: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (Alfa-2-Macroglobulin (µg/mL))
Measured: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (IL-8 (pg/mL))
Measured: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (MMP Type 9 (ng/mL))
Measured: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (MCP-1(pg/mL))
Measured: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (TIMP-1(ng/mL))
Measured: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (VEGF(pg/mL))
Measured: Baseline to 14 weeks
Change From Baseline in Lung Function Variables: Between-Treatment Differences (FAS) (FEV1 (L))
Measured: Baseline to 16 weeks
Change From Baseline in Lung Function Variables: Between-Treatment Differences (FAS) (FVC (L))
Measured: Baseline to 16 weeks
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.
Measured: Baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study start1 Feb 2012
- Primary completion1 Feb 2016
- Study completion1 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AstraZeneca AstraZeneca, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509677
- Sponsor's protocol ID
- RO-2455-402-RD
- Other IDs
- 2011-000582-13, U1111-1155-8767, D7120C00003
- Status last verified
- Nov 2019
- First submitted
- 21 Dec 2011
- Last updated
- 29 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rabe KF, Watz H, Baraldo S, Pedersen F, Biondini D, Bagul N, Hanauer G, Gohring UM, Purkayastha D, Roman J, Alagappan VKT, Saetta M. Anti-inflammatory effects of roflumilast in chronic obstructive pulmonary disease (ROBERT): a 16-week, randomised, placebo-controlled trial. Lancet Respir Med. 2018 Nov;6(11):827-836. doi: 10.1016/S2213-2600(18)30331-X. Epub 2018 Sep 14.
PubMed 30224319
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01509677
- Acronym / sponsor ID
- RO-2455-402-RD
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Keywords
- Roflumilast, Chronic Obstructive Pulmonary Disease, COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 1 Feb 2016 (actual)
- Study completion
- 1 Feb 2016 (actual)
- First posted
- 13 Jan 2012 (estimated)
- Results
- Posted 29 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a multicenter, double-blind, randomized, parallel group, phase 3 study. Patients included had a history of COPD (GOLD stage II-III, in Germany stage II only) with chronic productive cough.
There were 2 parallel treatment arms (placebo and roflumilast 500 μg once daily). A 1 to 1 randomization scheme was used, that is, patients were allocated to roflumilast 500 μg or placebo in equal proportions. Randomization was stratified by concomitant LABA use.
The total duration of this study was 24 weeks maximum per patient. The study consisted of the following periods:
- Single-blind placebo run-in period (6 weeks) with visits at Week -6 (visit 0 [V0]), Week -2 (V1), and Week 0 (V2, randomization visit), during which all patients received placebo.
- Double-blind treatment period (16 weeks) during which patients received either roflumilast or matching placebo with visits at Week 6 (V4), Week 14 (V5), and Week 16 (V6).
An additional visit (V3) within 2 weeks after bronchoscopy/bronchial biopsy was performed purely as a safety visit. The exact timing of this safety visit was to be determined by the investigator. Safety follow-up. All AEs were followed up to 30 days after the double-blind treatment period. An additional safety visit, V7, was scheduled within 2 weeks after the second bronchoscopy. The exact timing of the safety visit was to be determined by the investigator.
Patients were required not to take any food or drink overnight for at least 8 hours prior to returning to the study center for each visit. Patients were also asked to avoid strenuous exercise for 8 hours prior to each study visit and to avoid smoking for 4 hours prior to each study visit.
For visits where patients did not undergo blood collections or biopsies, the fasting requirement was only mandated if clinically indicated, per investigator judgment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roflumilast | Active comparator | Drug: Roflumilast500 μg tablet, once daily, oral administration in the morning after breakfast |
| Placebo | Placebo comparator | Drug: Placebotablet, once daily, oral administration in the morning after breakfast |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RoflumilastAlso: Daxas500 μg tablet, once daily, oral administration in the morning after breakfast | Drug | Roflumilast |
| PlaceboAlso: Placebo to Roflumilasttablet, once daily, oral administration in the morning after breakfast | Drug | Placebo |
Primary outcome
Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue.
Time frame: 16 weeks
Change in Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue
Time frame: Baseline to 16 weeks
31 secondary outcomes
CD68+ Count in Biopsied Material (Submucosa)
Time frame: 16 weeks
CD68+ Cell Count in Biopsied Material (Submucosa): Poisson Regression (Ratio)
Time frame: 16 weeks
Change From V2 to V6 in CD68+ Cell Count (Cells/mm^2) in Biopsied Material (Submucosa) (ITT)
Time frame: Baseline and 16 weeks
CD4+ Cell Counts in Biopsied Material (Submucosa):Poisson Regression Model
Time frame: 16 weeks
CD45+ Cell Counts in Biopsied Material (Submucosa):Poisson Regression Model
Time frame: 16 weeks
Neutrophils Cell Counts in Biopsied Material (Submucosa):Poisson Regression Model
Time frame: Baseline to 14 weeks
CD8+ Cell Count in Biopsied Material (Bronchial Epithelium): Poisson Regression Model
Time frame: 16 weeks
CD68+ Cell Count in Biopsied Material (Bronchial Epithelium):Poisson Regression Model
Time frame: 16 weeks
Change From V1 to V5 in Absolute Cell Count in Induced Sputum (10^6 Neutrophils/mL): Between-Treatment Difference
Time frame: Baseline to 14 weeks
Change From V1 to V5 in Absolute Cell Count inInduced Sputum (10^6 Macrophages/mL): Between-Treatment Difference
Time frame: Baseline to 14 weeks
Change From V1 to V5 in Absolute Cell Count inInduced Sputum (10^6 Eosinophils/mL): Between-Treatment Difference
Time frame: Baseline to 14 weeks
Change From V1 to V5 in Absolute Cell Count inInduced Sputum (10^6 Lymphocytes/mL): Between-Treatment Difference
Time frame: BAseline to 14 weeks
Change From V1 to V5 in Differential Cell Count in Induced Sputum(10^6 Neutrophils/mL)
Time frame: Baseline to 14 weeks
Change From V1 to V5 in Differential Cell Count in Induced Sputum(10^6 Macrophages/mL)
Time frame: Baseline to 14 weeks
Change From V1 to V5 in Differential Cell Count in Induced Sputum(10^6 Eosinophils/mL)
Time frame: Baseline to 14 weeks
Change From V1 to V5 in Differential Cell Count in Induced Sputum(10^6 Lymphocytes)/mL)
Time frame: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (Alfa- 2-Macroglobulin (µg/mL))
Time frame: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (IL-8 (pg/mL))
Time frame: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (MMP Type 9 (ng/mL))
Time frame: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (MCP-1 (pg/mL))
Time frame: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (TIMP-1 (ng/mL))
Time frame: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Induced Sputum: Primary Parameters of Interest (FAS) (VEGF (pg/mL))
Time frame: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (Alfa-2-Macroglobulin (µg/mL))
Time frame: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (IL-8 (pg/mL))
Time frame: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (MMP Type 9 (ng/mL))
Time frame: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (MCP-1(pg/mL))
Time frame: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (TIMP-1(ng/mL))
Time frame: Baseline to 14 weeks
Change From Baseline of Concentration of Inflammatory Biomarkers in Blood Serum: Primary Parameters of Interest (FAS) (VEGF(pg/mL))
Time frame: Baseline to 14 weeks
Change From Baseline in Lung Function Variables: Between-Treatment Differences (FAS) (FEV1 (L))
Time frame: Baseline to 16 weeks
Change From Baseline in Lung Function Variables: Between-Treatment Differences (FAS) (FVC (L))
Time frame: Baseline to 16 weeks
Wicoxon Signed-rank Test for Change From V2 to V6 in Post-bronchodilator FEV1/FVC
Time frame: Baseline to 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30224319Rabe KF, Watz H, Baraldo S, Pedersen F, Biondini D, Bagul N, Hanauer G, Gohring UM, Purkayastha D, Roman J, Alagappan VKT, Saetta M. Anti-inflammatory effects of roflumilast in chronic obstructive pulmonary disease (ROBERT): a 16-week, randomised, placebo-controlled trial. Lancet Respir Med. 2018 Nov;6(11):827-836. doi: 10.1016/S2213-2600(18)30331-X. Epub 2018 Sep 14.
- RO-2455-402-RD Updated Protocol v 6.0 (Amendment 12)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca AstraZeneca study director
AstraZeneca
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Roflumilast in people with COPD and Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany, United Kingdom, Poland, Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue. (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01509677, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019.