Chronic Obstructive Pulmonary DiseaseATLASNCT02187926
Evaluation of Clinical Effectiveness of Roflumilast in Routine Practice, in Chronic Obstructive Pulmonary Disease (COPD) Patients in Greece
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca.
Trial summary
The purpose of this study was to examine the characteristics of patients selected for treatment with roflumilast and the effectiveness and safety of roflumilast in patients with severe or very severe COPD treated in Hospital and outpatient specialist ward settings in Greece. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 2,577 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Dec 2013
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients prescribed roflumilast in Greece.
Who may be able to join
- Be diagnosed with COPD at stages 3 or 4 according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.
- Have the clinical phenotype of chronic bronchitis with cough and sputum production (with or without emphysema).
- Already be receiving treatment for their disease (inhaled bronchodilators (long-acting beta2-agonists (LABA), long-acting muscarinic antagonists (LAMA), short-acting beta2-agonists (SABA), short-acting muscarinic antagonist (SAMA)), inhaled corticosteroids (ICS), combination of inhaled bronchodilators and corticosteroids.
- Be aged over 40 years
Who cannot join
- None
About this study
Official title: Observational Study for the Evaluation of Clinical Effectiveness in Routine Practice of Daxas® (Roflumilast), in Approximately 2700 Patients With Severe and Very Severe COPD (Chronic Obstructive Pulmonary Disease) in Greece
The purpose of this study was to examine the characteristics of patients selected for treatment with roflumilast and the effectiveness and safety of roflumilast in patients with severe or very severe COPD treated in Hospital and outpatient specialist ward settings in Greece.
Read the detailed description
The drug being observed in this study is called roflumilast. Roflumilast is used to treat people who have chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis with a history of worsening symptoms. This study looked at side effects and the lung function of people who take roflumilast. The study enrolled 2577 patients who were already prescribed roflumilast as an add on to bronchiodilator treatment by their healthcare provider. This multi-centre trial was conducted in Greece. The overall time to participate in this study was up to 6 months. Participants were evaluated during routine appointments with their healthcare provider.
- 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 | Roflumilast will be administered according to the prescribing information of the approved label in Greece. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Forced Expiratory Volume in First Second (FEV1) at Month 6
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Measured: Baseline and Month 6
Change From Baseline in Forced Vital Capacity (FVC) at Month 6
Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Measured: Baseline and Month 6
Change From Baseline in Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity (FEV1/FVC) at Month 6
The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation.
Measured: Baseline and Month 6
Secondary outcomes (12)
Change from Baseline in Forced Expiratory Volume in First Second (FEV1) at Month 6
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Measured: Baseline and Month 6
Percentage of Participants with Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
A COPD exacerbation is an event characterised by a worsening in the patient's baseline dyspnoea, or cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management, and may be accompanied by increased wheeze, chest tightness, purulent sputum and symptoms of cold and/or fatigue.
Measured: Month 3 and Month 6
Percentage of Participants requiring Hospitalizations due to Exacerbations of COPD
Measured: Up to Month 6
Change from Baseline in Clinical COPD Questionnaire (CCQ) Total Score
Quality of life will be evaluated using the Clinical COPD Questionnaire (CCQ) 10-item questionnaire. The questions in the CCQ are divided into three area's, or domains: Symptoms: items 1, 2, 5 and 6; Functional state: items 7, 8, 9 and 10; Mental state: items 3 and 4. Individual items within the CCQ are equally weighted. The total score is calculated by adding the scores of the ten items and dividing that number by ten (= number of items). The total CCQ score, and the score on each of the three domains, varies between 0 (very good health status) to 6 (extremely poor health status).
Measured: Baseline and Months 3 and 6
Change from Baseline in MRC Dyspnea Scale
The Medical Research Council (MRC) breathlessness (dyspnea) scale comprises five statements that describe almost the entire range of respiratory disability: 1 - Not troubled by breathlessness except on strenuous exercise; 2 - Short of breath when hurrying or walking up a slight hill; 3 - Walks slower than contemporaries on level ground because of breathlessness, or has to stop for breath when walking at own pace; 4 - Stops for breath after walking about 100m or after a few minutes on level ground; 5 - Too breathless to leave the house, or breathless when dressing or undressing. The highest numbered question to which the subject answered 'Yes' is the Dyspnea Scale Score.
Measured: Baseline and Months 3 and 6
Patient's Satisfaction with Roflumilast
Is the perception of the participant according to the scale provided.
Measured: Baseline and Months 3 and 6
Physician's Satisfaction with Roflumilast
Is the perception of Physician taking into consideration the effectiveness and the tolerability of the drug.
Measured: Baseline and Months 3 and 6
Change From Baseline in Forced Vital Capacity (FVC) at Month 3
Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Measured: Baseline and Month 3
Change From Baseline in Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity (FEV1/FVC) at Month 3
The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation.
Measured: Baseline and Month 3
Compliance to treatment
According to physician's judgment
Measured: 6 months
Number of participants with adverse drug reactions (ADR)
An ADR is any response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of diseases or for the restoration, correction or modification of physiological function.
Measured: 6 months
Concomitant administration of inhaled bronchodilators and corticosteroids
Concomitant administration of inhaled bronchodilators and corticosteroids, either separately or in combination.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startMay 2011
- Primary completionDec 2013
- Study completionDec 2013
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,577 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
- NCT02187926
- Sponsor's protocol ID
- RO-2455-401-GR
- Acronym
- ATLAS
- Status last verified
- Sep 2016
- First submitted
- 29 Apr 2014
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study for the Evaluation of Clinical Effectiveness in Routine Practice of Daxas® (Roflumilast), in Approximately 2700 Patients With Severe and Very Severe COPD (Chronic Obstructive Pulmonary Disease) in Greece
- ClinicalTrials.gov ID
- NCT02187926
- Acronym / sponsor ID
- ATLAS / RO-2455-401-GR
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Drug therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,577 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Jul 2014 (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.
The purpose of this study was to examine the characteristics of patients selected for treatment with roflumilast and the effectiveness and safety of roflumilast in patients with severe or very severe COPD treated in Hospital and outpatient specialist ward settings in Greece.
Detailed description
The drug being observed in this study is called roflumilast. Roflumilast is used to treat people who have chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis with a history of worsening symptoms. This study looked at side effects and the lung function of people who take roflumilast. The study enrolled 2577 patients who were already prescribed roflumilast as an add on to bronchiodilator treatment by their healthcare provider. This multi-centre trial was conducted in Greece. The overall time to participate in this study was up to 6 months. Participants were evaluated during routine appointments with their healthcare provider.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Roflumilast | – | –Roflumilast will be administered according to the prescribing information of the approved label in Greece. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients prescribed roflumilast in Greece.
Key inclusion criteria (4 listed)
- Be diagnosed with COPD at stages 3 or 4 according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.
- Have the clinical phenotype of chronic bronchitis with cough and sputum production (with or without emphysema).
- Already be receiving treatment for their disease (inhaled bronchodilators (long-acting beta2-agonists (LABA), long-acting muscarinic antagonists (LAMA), short-acting beta2-agonists (SABA), short-acting muscarinic antagonist (SAMA)), inhaled corticosteroids (ICS), combination of inhaled bronchodilators and corticosteroids.
- Be aged over 40 years
Key exclusion criteria (1 listed)
- None
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
Change from Baseline in Forced Expiratory Volume in First Second (FEV1) at Month 6
Time frame: Baseline and Month 6
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Change From Baseline in Forced Vital Capacity (FVC) at Month 6
Time frame: Baseline and Month 6
Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
Change From Baseline in Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity (FEV1/FVC) at Month 6
Time frame: Baseline and Month 6
The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation.
12 secondary outcomes
Change from Baseline in Forced Expiratory Volume in First Second (FEV1) at Month 6
Time frame: Baseline and Month 6
Percentage of Participants with Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Time frame: Month 3 and Month 6
Percentage of Participants requiring Hospitalizations due to Exacerbations of COPD
Time frame: Up to Month 6
Change from Baseline in Clinical COPD Questionnaire (CCQ) Total Score
Time frame: Baseline and Months 3 and 6
Change from Baseline in MRC Dyspnea Scale
Time frame: Baseline and Months 3 and 6
Patient's Satisfaction with Roflumilast
Time frame: Baseline and Months 3 and 6
Physician's Satisfaction with Roflumilast
Time frame: Baseline and Months 3 and 6
Change From Baseline in Forced Vital Capacity (FVC) at Month 3
Time frame: Baseline and Month 3
Change From Baseline in Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity (FEV1/FVC) at Month 3
Time frame: Baseline and Month 3
Compliance to treatment
Time frame: 6 months
Number of participants with adverse drug reactions (ADR)
Time frame: 6 months
Concomitant administration of inhaled bronchodilators and corticosteroids
Time frame: 6 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 5 Dec 2016.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca.
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 4 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 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from Baseline in Forced Expiratory Volume in First Second (FEV1) at Month 6 (time frame: Baseline and Month 6). The study lists 3 primary outcomes in all. 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 5 Dec 2016.