Trial to Assess the Anti-inflammatory Effects of Roflumilast in Chronic Obstructive Pulmonary Disease
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
4 other identifiers
interventional
158
5 countries
20
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2012
Typical duration for phase_3
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2011
CompletedFirst Posted
Study publicly available on registry
January 13, 2012
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedResults Posted
Study results publicly available
November 29, 2019
CompletedNovember 29, 2019
November 1, 2019
4 years
December 21, 2011
January 23, 2017
November 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue.
16 weeks
Change in Number of CD8+ Inflammatory Cells in Bronchial Biopsy Tissue
Baseline to 16 weeks
Secondary Outcomes (31)
CD68+ Count in Biopsied Material (Submucosa)
16 weeks
CD68+ Cell Count in Biopsied Material (Submucosa): Poisson Regression (Ratio)
16 weeks
Change From V2 to V6 in CD68+ Cell Count (Cells/mm^2) in Biopsied Material (Submucosa) (ITT)
Baseline and 16 weeks
CD4+ Cell Counts in Biopsied Material (Submucosa):Poisson Regression Model
16 weeks
CD45+ Cell Counts in Biopsied Material (Submucosa):Poisson Regression Model
16 weeks
- +26 more secondary outcomes
Study Arms (2)
Roflumilast
ACTIVE COMPARATOR500 μg tablet, once daily, oral administration in the morning after breakfast
Placebo
PLACEBO COMPARATORtablet, once daily, oral administration in the morning after breakfast
Interventions
500 μg tablet, once daily, oral administration in the morning after breakfast
tablet, once daily, oral administration in the morning after breakfast
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (20)
Unknown Facility
København NV, DK-2400, Denmark
Unknown Facility
København NV, Denmark
Unknown Facility
Freiburg im Breisgau, Germany
Unknown Facility
Großhansdorf, Germany
Unknown Facility
Hanover, Germany
Unknown Facility
Heidelberg, Germany
Unknown Facility
Immenhausen, Germany
Unknown Facility
Kiel, Germany
Unknown Facility
Mainz, Germany
Unknown Facility
Bialystok, Poland
Unknown Facility
Krakow, Poland
Unknown Facility
Lodz, 90-153, Poland
Unknown Facility
Lodz, Poland
Unknown Facility
Lund, Sweden
Unknown Facility
Cottingham, United Kingdom
Unknown Facility
Dafen, United Kingdom
Unknown Facility
Leicester, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Manchester, United Kingdom
Unknown Facility
Norwich, NR4 7UY, United Kingdom
Related Publications (1)
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.
PMID: 30224319DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- AstraZeneca Clinical Study Information Center
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
AstraZeneca AstraZeneca
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2011
First Posted
January 13, 2012
Study Start
February 1, 2012
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
November 29, 2019
Results First Posted
November 29, 2019
Record last verified: 2019-11