Chronic Obstructive Pulmonary DiseaseCOPD LanguageNCT01219946
A Study for the Assessment of the Words Used by Patients and Physicians to Express the Symptoms of Chronic Obstructive Pulmonary Disease (COPD)
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 32 sites in Greece.
Trial summary
Chronic obstructive pulmonary disease (COPD) is characterized by a progressive decline in lung function and increased symptoms such as breathlessness/dyspnoea, cough and expectoration. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 700 participants
- Where
- 32 sitesGreece
- Study dates
- Oct 2010to Mar 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Chronic Obstructive Pulmonary Disease
Who may be able to join
- Aged 45-75 years
- Current or former smokers
- Known history of COPD for at least 6 months before enrolment into the study documented by spirometry (FEV1 /FVC <70%)
- Patients with stable COPD (no exacerbation within the last month before enrolment into the study) under treatment with a long-acting inhaled bronchodilator (LABA and/or LAMA) alone or in combination with an inhaled corticosteroid
- Written consent for participation in the study
- Patients who are able to complete by themselves in Greek a questionnaire on COPD.
Who cannot join
- Patients with diagnosed Asthma
- Patients with any psychiatric, neurological or other disorder render them unable to complete the COPD questionnaire by themselves
- The patient participates in another study.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Greece32 sites
Research Site
Agrinio, Sterea
Research Site
Alexándreia, Makedonia
Research Site
Athens, Attica
Research Site
Chania, Crete
Research Site
Corfu, Eptanisa
Research Site
Drama, Makedonia
Research Site
Florina, Makedonia
Research Site
Halkida, Sterea
Research Site
Heraklion, Crete
Research Site
Ioannina, Ipiros
Research Site
Itea, Sterea
Research Site
Kallithea, Attica
Research Site
Katerini, Makedonia
Research Site
Kavala, Makedonia
Research Site
Kozani, Makedonia
Research Site
Krestena, Peloponisos
Research Site
Larissa, Kyklades
Research Site
Lechainá, Peloponisos
Research Site
Livadia, Sterea
Research Site
Marousi, Attica
Research Site
Megara, Attica
Research Site
Mykonos, Kyklades
Research Site
Nea Ionia, Attica
Research Site
Nea Makri, Attica
Research Site
Pátrai, Peloponisos
Research Site
Piraeus, Attica
Research Site
Rhodes, Dodekanisa
Research Site
Serres, Makedonia
Research Site
Skála, Peloponisos
Research Site
Thesaloniki, Makedonia
Research Site
Volos, Thesalia
Research Site
Xánthi, Traki
About this study
Official title: A Cross Sectional Study for the Assessment of the Words Used by Patients and Physicians to Express the Symptoms of Chronic Obstructive Pulmonary Disease and the Limitations of Patients' Activities in Primary Care.
Chronic obstructive pulmonary disease (COPD) is characterized by a progressive decline in lung function and increased symptoms such as breathlessness/dyspnoea, cough and expectoration.
Even though subjective in nature, the symptomatology of COPD and mainly that of breathlessness/dyspnoea has been studied with the use of objective measurement tools. Taking into consideration that the symptoms experienced by the patient who suffers from a progressive disease such as COPD can only be perceived and interpreted by the patient him- or herself, and thus difficult to be quantified, COPD remains a challenge in clinical research.
Read more
Therefore, there is a need to carry out qualitative studies that will provide insight into the wide spectrum of COPD symptomatology from the patient's perspective. In addition, a further mapping of the impact that COPD symptoms' perception has on a patient's life is required, as well as of the different pathways through which symptoms' perception is interpreted regarding the limitations of daily living activities, and the subsequent impact on disease management. The more the physician learns on the embodied experience of COPD, the better he/she may assist the patient in achieving optimal COPD management.
Thus this cross-sectional observational study was designed aiming to obtain these data. Specifically, the study aims to evaluate the most frequently used words by the patients and the physicians to express the symptoms of COPD as well as the limitation of activities that it causes.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, symptoms
- 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 |
|---|---|---|
| 1 | Patients with Chronic Obstructive Pulmonary Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Words used by the patients and the physicians to express the symptoms of COPD as well as the limitations of patients' daily living activities caused by COPD.
Measured: End of recruitment (estimated timeframe :2.5 months)
Secondary outcomes (20)
Age
Measured: End of recruitment (estimated timeframe :2.5 months)
Gender
Measured: End of recruitment (estimated timeframe :2.5 months)
Place of residence
Measured: End of recruitment (estimated timeframe :2.5 months)
Marital status
Measured: End of recruitment (estimated timeframe :2.5 months)
Native language
Measured: End of recruitment (estimated timeframe :2.5 months)
Educational level
Measured: End of recruitment (estimated timeframe :2.5 months)
Occupation
Measured: End of recruitment (estimated timeframe :2.5 months)
Co-morbidities
Measured: End of recruitment (estimated timeframe :2.5 months)
Years / months since COPD diagnosis and years with COPD symptoms
Measured: End of recruitment (estimated timeframe :2.5 months)
Smoking history
Measured: End of recruitment (estimated timeframe :2.5 months)
Number of exacerbations during the last year
Measured: End of recruitment (estimated timeframe :2.5 months)
Current therapy
Measured: End of recruitment (estimated timeframe :2.5 months)
CCQ score
Measured: End of recruitment (estimated timeframe :2.5 months)
Compliance with therapy
Measured: End of recruitment (estimated timeframe :2.5 months)
Actions/therapeutic recommendations by the physician associated with each chosen word that express the chronic daily symptoms
Measured: End of recruitment (estimated timeframe :2.5 months)
Scale for the assessment of the severity of the relevant symptoms
Measured: End of recruitment (estimated timeframe :2.5 months)
Actions/therapeutic recommendations by the physician when any of the symptoms worsen
Measured: End of recruitment (estimated timeframe :2.5 months)
Severity scale regarding how the patient experiences each of the chosen words that express the chronic daily symptoms
Measured: End of recruitment (estimated timeframe :2.5 months)
Related actions initiated by the patient regarding chronic daily symptoms
Measured: End of recruitment (estimated timeframe :2.5 months)
Related actions initiated by the patient when the symptoms worsen.
Measured: End of recruitment (estimated timeframe :2.5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2011
- Study completionMar 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Panagiotis Pontikis, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219946
- Sponsor's protocol ID
- NIS-RGR-DUM-2010/1
- Acronym
- COPD Language
- Status last verified
- Mar 2012
- First submitted
- 8 Oct 2010
- Last updated
- 21 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross Sectional Study for the Assessment of the Words Used by Patients and Physicians to Express the Symptoms of Chronic Obstructive Pulmonary Disease and the Limitations of Patients' Activities in Primary Care.
- ClinicalTrials.gov ID
- NCT01219946
- Acronym / sponsor ID
- COPD Language / NIS-RGR-DUM-2010/1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 13 Oct 2010 (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.
Chronic obstructive pulmonary disease (COPD) is characterized by a progressive decline in lung function and increased symptoms such as breathlessness/dyspnoea, cough and expectoration.
Even though subjective in nature, the symptomatology of COPD and mainly that of breathlessness/dyspnoea has been studied with the use of objective measurement tools. Taking into consideration that the symptoms experienced by the patient who suffers from a progressive disease such as COPD can only be perceived and interpreted by the patient him- or herself, and thus difficult to be quantified, COPD remains a challenge in clinical research.
Therefore, there is a need to carry out qualitative studies that will provide insight into the wide spectrum of COPD symptomatology from the patient's perspective. In addition, a further mapping of the impact that COPD symptoms' perception has on a patient's life is required, as well as of the different pathways through which symptoms' perception is interpreted regarding the limitations of daily living activities, and the subsequent impact on disease management. The more the physician learns on the embodied experience of COPD, the better he/she may assist the patient in achieving optimal COPD management.
Thus this cross-sectional observational study was designed aiming to obtain these data. Specifically, the study aims to evaluate the most frequently used words by the patients and the physicians to express the symptoms of COPD as well as the limitation of activities that it causes.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with Chronic Obstructive Pulmonary Disease |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Chronic Obstructive Pulmonary Disease
Key inclusion criteria (6 listed)
- Aged 45-75 years
- Current or former smokers
- Known history of COPD for at least 6 months before enrolment into the study documented by spirometry (FEV1 /FVC <70%)
- Patients with stable COPD (no exacerbation within the last month before enrolment into the study) under treatment with a long-acting inhaled bronchodilator (LABA and/or LAMA) alone or in combination with an inhaled corticosteroid
- Written consent for participation in the study
Key exclusion criteria (3 listed)
- Patients with diagnosed Asthma
- Patients with any psychiatric, neurological or other disorder render them unable to complete the COPD questionnaire by themselves
- The patient participates in another study.
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
Words used by the patients and the physicians to express the symptoms of COPD as well as the limitations of patients' daily living activities caused by COPD.
Time frame: End of recruitment (estimated timeframe :2.5 months)
20 secondary outcomes
Age
Time frame: End of recruitment (estimated timeframe :2.5 months)
Gender
Time frame: End of recruitment (estimated timeframe :2.5 months)
Place of residence
Time frame: End of recruitment (estimated timeframe :2.5 months)
Marital status
Time frame: End of recruitment (estimated timeframe :2.5 months)
Native language
Time frame: End of recruitment (estimated timeframe :2.5 months)
Educational level
Time frame: End of recruitment (estimated timeframe :2.5 months)
Occupation
Time frame: End of recruitment (estimated timeframe :2.5 months)
Co-morbidities
Time frame: End of recruitment (estimated timeframe :2.5 months)
Years / months since COPD diagnosis and years with COPD symptoms
Time frame: End of recruitment (estimated timeframe :2.5 months)
Smoking history
Time frame: End of recruitment (estimated timeframe :2.5 months)
Number of exacerbations during the last year
Time frame: End of recruitment (estimated timeframe :2.5 months)
Current therapy
Time frame: End of recruitment (estimated timeframe :2.5 months)
CCQ score
Time frame: End of recruitment (estimated timeframe :2.5 months)
Compliance with therapy
Time frame: End of recruitment (estimated timeframe :2.5 months)
Actions/therapeutic recommendations by the physician associated with each chosen word that express the chronic daily symptoms
Time frame: End of recruitment (estimated timeframe :2.5 months)
Scale for the assessment of the severity of the relevant symptoms
Time frame: End of recruitment (estimated timeframe :2.5 months)
Actions/therapeutic recommendations by the physician when any of the symptoms worsen
Time frame: End of recruitment (estimated timeframe :2.5 months)
Severity scale regarding how the patient experiences each of the chosen words that express the chronic daily symptoms
Time frame: End of recruitment (estimated timeframe :2.5 months)
Related actions initiated by the patient regarding chronic daily symptoms
Time frame: End of recruitment (estimated timeframe :2.5 months)
Related actions initiated by the patient when the symptoms worsen.
Time frame: End of recruitment (estimated timeframe :2.5 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 21 Mar 2012.
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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.
Panagiotis Pontikis study director
32 sites in 1 country: 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 32 sites in Greece.
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 6 inclusion and 3 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 21 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Greece. 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?
Words used by the patients and the physicians to express the symptoms of COPD as well as the limitations of patients' daily living activities caused by COPD. (time frame: End of recruitment (estimated timeframe :2.5 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 21 Mar 2012.