Chronic Obstructive Pulmonary DiseaseNCT02015767
Patient Registry of Roflumilast In Real Life
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 51 sites in 6 countries.
Trial summary
A patient registry to capture real life data and demonstrate the performance of roflumilast (Daxas®) in a standard clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 1,950 participants
- Where
- 51 sitesin 6 countries
- Study dates
- 1 Feb 2013to 31 Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants prescribed roflumilast (Daxas®) according to local guidelines and marketing authorization. The registry sites will comprise hospitals, and office-based physicians. The investigators will be mainly pulmonologists, or as per the standard practice of the specific country.
Who may be able to join
- Signed informed consent to the data collection
- Roflumilast (Daxas®) treatment initiated in Roflumilast (Daxas®) naïve patients at the time of registry
Who cannot join
- There are no exclusion criteria per se. However it is expected that patients are treated according to locally approved marketing authorisation.
Trial locations and contacts
51 sites in 6 countries.
51 sites in 6 countries
Greece16 sites
Study site
Agrinio
Study site
Athens
Study site
Edessa
Study site
Herakleion-Crete
Study site
Imitos
Study site
Kaisarianí
Study site
Kalamaria
Study site
Katerini
Study site
Nafpaktos
Study site
Pátrai
Study site
Peristeri
Study site
Piraeus
Study site
Ptolemaida
Study site
Pýrgos
Study site
Thessaloniki
Study site
Volos
Slovakia14 sites
Study site
Banská Bystrica
Study site
Bardejov
Study site
Bratislava
Study site
Humenné
Study site
Malacky
Study site
Michalovce
Study site
Nitra
Study site
Považská Bystrica
Study site
Prešov
Study site
Revúca
Study site
Senica
Study site
Spišská Nová Ves
Study site
Štúrovo
Study site
Topoľčany
Norway9 sites
Study site
Arendal
Study site
Bergen
Study site
Elverum
Study site
Fredrikstad
Study site
Kongsvinger
Study site
Sandvika
Study site
Skien
Study site
Straume
Study site
Tønsberg
South Korea6 sites
Study site
Busan
Study site
Daegu
Study site
Gwangju
Study site
Jeonju
Study site
Seoul
Study site
Suwon
Bulgaria5 sites
Study site
Pleven
Study site
Razgrad
Study site
Sofia
Study site
Troyan Municipality
Study site
Vratsa
About this study
A patient registry to capture real life data and demonstrate the performance of roflumilast (Daxas®) in a standard clinical practice.
Read the detailed description
The drug being tested in this observational study design is called roflumilast, but not as an therapeutic intervention. Roflumilast is approved for and marketed globally for maintenance treatment of severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
This study will capture real life data and demonstrate the performance of roflumilast in a standard clinical practice. The study will enroll approximately 1350 (EU)+600(North Asia) patients. This multi-centre trial will be conducted in at least 4 EU and 2 North Asian countries.
The overall time to participate in this study is 12 months. No visits, diagnostic procedures or monitoring will take place, which would not happen had the patient not been included in the study.
Participants will be followed according to usual practice and data recorded approximately at 6 months and at 12 months of roflumilast treatment.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Drug therapy
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast | Participants prescribed roflumilast (Daxas®) according to local guidelines and marketing authorization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of observed exacerbations
Number of exacerbations observed during the study period and per patient per year
Measured: 12 months
Secondary outcomes (10)
Severity of exacerbations
Severity of exacerbations (proportion of exacerbations requiring systemic corticosteroid treatment and/or antibiotics or requiring hospitalization).
Measured: 12 months
Seasonal variation of exacerbation
Seasonal variation of exacerbation during Roflumilast treatment.
Measured: 12 months
Number of hospitalizations due to COPD exacerbations
Number of hospitalizations due to Chronic obstructive pulmonary disease (COPD) exacerbations per patient per year.
Measured: 12 months
Change from Baseline in lung function parameters (FEV1 and FEV1/FVC)
Change in lung function parameters parameters FEV1(Forced Expired Volume measured after 1 second expiration) and FEV1/FVC (Forced Vital Capacity) from Baseline to the last recorded value and to the end of the study.
Measured: Baseline and Month 12
Change from Baseline in blood oxygen saturation
Change in blood oxygen saturation assessed with pulse oximetry from Baseline to the last recorded value and the end of the study.
Measured: Baseline and Month 12
Percentage of compliance to treatment
Estimated percentage of prescribed doses taken since the last date of data collection.
Measured: 12 months
Changes in concomitant administration of COPD maintenance treatments
Changes in concomitant administration of COPD maintenance treatments since start of roflumilast treatment.
Measured: 12 months
Health status using the COPD Assessment Questionnaire (CAT)
Measured: Baseline, Month 6 and Month 12
Change from Baseline in breathlessness
Change in breathlessness assessed using the Modified Medical Research Council (mMRC) dyspnoea scale, from Baseline to the end of observation.
Measured: Baseline and Month 12
Number of Participants with adverse Drug Reactions (ADRs)
An ADR is a response to an observed medicinal product which is noxious and unintended resulting not only from the authorised use of a medicinal product at normal doses, but also from medication errors and uses outside the terms of the marketing authorisation, including the misuse and abuse of the medicinal product.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study start1 Feb 2013
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,950 participants (estimated)
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
- NCT02015767
- Sponsor's protocol ID
- RO-2455-407-RD
- Other IDs
- U1111-1146-5619
- Status last verified
- May 2017
- First submitted
- 13 Dec 2013
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Registry of Roflumilast In Real Life
- ClinicalTrials.gov ID
- NCT02015767
- Acronym / sponsor ID
- RO-2455-407-RD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Drug therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,950 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A patient registry to capture real life data and demonstrate the performance of roflumilast (Daxas®) in a standard clinical practice.
Detailed description
The drug being tested in this observational study design is called roflumilast, but not as an therapeutic intervention. Roflumilast is approved for and marketed globally for maintenance treatment of severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
This study will capture real life data and demonstrate the performance of roflumilast in a standard clinical practice. The study will enroll approximately 1350 (EU)+600(North Asia) patients. This multi-centre trial will be conducted in at least 4 EU and 2 North Asian countries.
The overall time to participate in this study is 12 months. No visits, diagnostic procedures or monitoring will take place, which would not happen had the patient not been included in the study.
Participants will be followed according to usual practice and data recorded approximately at 6 months and at 12 months of roflumilast treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Roflumilast | – | –Participants prescribed roflumilast (Daxas®) according to local guidelines and marketing authorization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants prescribed roflumilast (Daxas®) according to local guidelines and marketing authorization. The registry sites will comprise hospitals, and office-based physicians. The investigators will be mainly pulmonologists, or as per the standard practice of the specific country.
Key inclusion criteria (2 listed)
- Signed informed consent to the data collection
- Roflumilast (Daxas®) treatment initiated in Roflumilast (Daxas®) naïve patients at the time of registry
Key exclusion criteria (1 listed)
- There are no exclusion criteria per se. However it is expected that patients are treated according to locally approved marketing authorisation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of observed exacerbations
Time frame: 12 months
Number of exacerbations observed during the study period and per patient per year
10 secondary outcomes
Severity of exacerbations
Time frame: 12 months
Seasonal variation of exacerbation
Time frame: 12 months
Number of hospitalizations due to COPD exacerbations
Time frame: 12 months
Change from Baseline in lung function parameters (FEV1 and FEV1/FVC)
Time frame: Baseline and Month 12
Change from Baseline in blood oxygen saturation
Time frame: Baseline and Month 12
Percentage of compliance to treatment
Time frame: 12 months
Changes in concomitant administration of COPD maintenance treatments
Time frame: 12 months
Health status using the COPD Assessment Questionnaire (CAT)
Time frame: Baseline, Month 6 and Month 12
Change from Baseline in breathlessness
Time frame: Baseline and Month 12
Number of Participants with adverse Drug Reactions (ADRs)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Related InfoLink provided by the sponsor.
- Related InfoLink 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
51 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 51 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in Greece, Slovakia, Norway, South Korea, Bulgaria and 1 more country. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 observed exacerbations (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2017.