Chronic Obstructive Pulmonary DiseaseNCT02128529
Epidemiology of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Chronic Obstructive Pulmonary Disease and Chronic Bronchitis, run by AstraZeneca.
Trial summary
The purpose of this study was to investigate the prevalence of chronic bronchitis in patients suffering from moderate to very severe chronic obstructive pulmonary disease (COPD), and to assess the difference in exacerbation rates in patients suffering from moderate to very severe COPD with chronic bronchitis vs. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Chronic Bronchitis
- How many people
- 976 participants
- Where
- No sites listed yet
- Study dates
- Oct 2010to Apr 2011
- 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 with or without chronic bronchitis in Belgium and Luxembourg.
Who may be able to join
- 1. Written informed consent. 2. Age ≥ 40 years. 3. Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio (post-bronchodilator) <70%. 4. FEV1 (post-bronchodilator) < 80% of predicted.
Who cannot join
- 1. Moderate and severe exacerbations during the last 4 weeks. 2. Pregnancy. 3. Already participated in the study (allowed to participate only once).
About this study
Official title: A Cross-sectional Observational Study in Pulmonology Departments in Belgium and Luxembourg to Investigate the Epidemiology of Chronic Bronchitis in Patients Suffering From Moderate to Very Severe COPD
The purpose of this study was to investigate the prevalence of chronic bronchitis in patients suffering from moderate to very severe chronic obstructive pulmonary disease (COPD), and to assess the difference in exacerbation rates in patients suffering from moderate to very severe COPD with chronic bronchitis vs. a population of patients without chronic bronchitis.
Read the detailed description
This was an observational study so participants only took medication that was prescribed by their regular healthcare provider. No additional study medication was administered. This study enrolled patients who were previously diagnosed with moderate to very severe chronic obstructive pulmonary disease (COPD). This study looked at the prevalence of chronic bronchitis in patients suffering from moderate, severe or very severe COPD, and it also compared worsening of COPD in patients with or without chronic bronchitis. This study enrolled 976 patients. This multi-centre trial was conducted in Belgium and Luxembourg. The overall time to participate in this study was at a single, regularly scheduled visit at the pulmonologists office. There were no follow-up assessments for this study.
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
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 |
|---|---|---|
| Chronic obstructive pulmonary disease | Patients with chronic obstructive pulmonary disease will undergo a single visit with the collection of data from his/her records. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Chronic Bronchitis
Chronic bronchitis is defined as the presence of cough and sputum production for at least 3 months in each of 2 consecutive years.
Measured: 2 years prior to the study visit on Day 1
Exacerbation Rate
An exacerbation is defined as an event in the natural course of the disease characterised by a change in the patient's baseline dyspnoea, cough, and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication in a patient with underlying COPD for three or more days. Exacerbation rate is defined as number of exacerbations per year.
Measured: 12 Months prior to the study visit
Secondary outcomes (6)
Percentage of Participants with Moderate, Severe or Very Severe COPD
COPD severity will be assessed based on post-bronchodilator forced expiratory volume after 1 second (FEV1) and post-bronchodilator ratio of FEV1 to forced vital capacity (FVC) and then classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD): Moderate - FEV1/FVC<0.7, FEV1 50-79% normal; Severe - FEV1/FVC<0.70, FEV1 30-49% normal; Very Severe - FEV1/FVC<0.70, FEV1 <30% predicted or FEV1<50% predicted plus chronic respiratory failure.
Measured: At the study visit (Day 1)
Percentage of Participants with Risk Factors
Risk factors are defined as smoking status and exposure to environmental risk factors (mineral dusts, organic dusts, fumes and vapours or metallic dusts).
Measured: 12 months prior to study visit
Changes in Post-bronchodilator forced expiratory volume after 1 second (FEV1)
Measured: At the study visit, and 6 months and 12 Months prior to study visit
Percentage of Participants with Other Relevant Diseases
Relevant disease are defined as respiratory diseases (allergy, asthma, chronic respiratory failure), cardiovascular diseases (ischaemic heart disease, heart failure, hypertension), and other diseases (which could be related to COPD) (osteoporosis, skeletal muscle wasting, cachexia, diabetes mellitus, depression, normocytic, anaemia, gastroesophageal reflux disease and lung cancer).
Measured: 12 months prior to study visit
COPD Treatment
COPD treatments are defined as inhaled therapies, oral therapies and other therapies administered within the last 12 months as influenza vaccination and smoking cessation therapy.
Measured: At the study visit (Day 1)
Changes in post-bronchodilator ratio of FEV1 to forced vital capacity (FVC)
Measured: At the study visit, and 6 months and 12 Months prior to study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startOct 2010
- Primary completionApr 2011
- Study completionApr 2011
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
- Cross-sectional
- Enrolment
- 976 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
- NCT02128529
- Sponsor's protocol ID
- RO-2455-401-BE
- Status last verified
- Sep 2016
- First submitted
- 29 Apr 2014
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Observational Study in Pulmonology Departments in Belgium and Luxembourg to Investigate the Epidemiology of Chronic Bronchitis in Patients Suffering From Moderate to Very Severe COPD
- ClinicalTrials.gov ID
- NCT02128529
- Acronym / sponsor ID
- RO-2455-401-BE
- Keywords
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 976 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 1 May 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 investigate the prevalence of chronic bronchitis in patients suffering from moderate to very severe chronic obstructive pulmonary disease (COPD), and to assess the difference in exacerbation rates in patients suffering from moderate to very severe COPD with chronic bronchitis vs. a population of patients without chronic bronchitis.
Detailed description
This was an observational study so participants only took medication that was prescribed by their regular healthcare provider. No additional study medication was administered. This study enrolled patients who were previously diagnosed with moderate to very severe chronic obstructive pulmonary disease (COPD). This study looked at the prevalence of chronic bronchitis in patients suffering from moderate, severe or very severe COPD, and it also compared worsening of COPD in patients with or without chronic bronchitis. This study enrolled 976 patients. This multi-centre trial was conducted in Belgium and Luxembourg. The overall time to participate in this study was at a single, regularly scheduled visit at the pulmonologists office. There were no follow-up assessments for this study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic obstructive pulmonary disease | – | –Patients with chronic obstructive pulmonary disease will undergo a single visit with the collection of data from his/her records. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients with or without chronic bronchitis in Belgium and Luxembourg.
Key inclusion criteria (1 listed)
- 1. Written informed consent. 2. Age ≥ 40 years. 3. Forced expiratory volume in one second (FEV1)/Forced vital capacity (FVC) ratio (post-bronchodilator) <70%. 4. FEV1 (post-bronchodilator) < 80% of predicted.
Key exclusion criteria (1 listed)
- 1. Moderate and severe exacerbations during the last 4 weeks. 2. Pregnancy. 3. Already participated in the study (allowed to participate only once).
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
Percentage of Participants with Chronic Bronchitis
Time frame: 2 years prior to the study visit on Day 1
Chronic bronchitis is defined as the presence of cough and sputum production for at least 3 months in each of 2 consecutive years.
Exacerbation Rate
Time frame: 12 Months prior to the study visit
An exacerbation is defined as an event in the natural course of the disease characterised by a change in the patient's baseline dyspnoea, cough, and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication in a patient with underlying COPD for three or more days. Exacerbation rate is defined as number of exacerbations per year.
6 secondary outcomes
Percentage of Participants with Moderate, Severe or Very Severe COPD
Time frame: At the study visit (Day 1)
Percentage of Participants with Risk Factors
Time frame: 12 months prior to study visit
Changes in Post-bronchodilator forced expiratory volume after 1 second (FEV1)
Time frame: At the study visit, and 6 months and 12 Months prior to study visit
Percentage of Participants with Other Relevant Diseases
Time frame: 12 months prior to study visit
COPD Treatment
Time frame: At the study visit (Day 1)
Changes in post-bronchodilator ratio of FEV1 to forced vital capacity (FVC)
Time frame: At the study visit, and 6 months and 12 Months prior to study visit
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 2 Nov 2016.
Related trials for Chronic Obstructive Pulmonary Disease
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
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 and Chronic Bronchitis, 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 1 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 2 Nov 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?
Percentage of Participants with Chronic Bronchitis (time frame: 2 years prior to the study visit on Day 1). 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?
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 2 Nov 2016.