The primary objective of this study is:• To compare the rate of moderate-severe COPD exacerbations in COPD patients with and without cardiovascular diseases (CVD) The secondary objectives are:• To compare the rate of moderate-severe COPD…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Rate of COPD exacerbations (moderate-severe severity), based on a healthcare
utilisation defined as a worsening of symptoms that require oral
corticosteroids and/or antibiotics and/or hospitalizations
• Presence and severity of pre-defined cardiovascular diseases
Secondary outcome
• Presence and severity of other treated comorbidities
• Spirometry measurements - FEV1, forced vital capacity (FVC), FEV1/FVC ratio
• Health status scores - CAT; EQ-5D; Hospital Anxiety and Depression Scale
(HADS); Epworth Sleepiness Scale (ESS); Frequency Scale for the Symptoms of
Gastro-oesophageal reflux disease (FSSG)
• Medical Research Council (MRC) scores
• Number of deaths
• Healthcare utilisation: number of unscheduled GP contacts and
hospitalisations
• Blood chemistry, including glucose; Haemoglobin A1C (HbA1c);; low density
lipoprotein (LDL-c), High density lipoprotein (HDL-c), Total cholesterol;
triglycerides, prohormone natiuretice peptide (pro-BNP); high-sensitivity C
reactive protein (hs-CRP); protein; full blood count
• Blood pressure and electrocardiogram (ECG)
• Number of bone fractures
Background summary
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity
and mortality worldwide. Comorbid diseases are an important factor in the
prognosis and functional capabilities of COPD patients. There is a relationship
between cardiac comorbidity and COPD exacerbation frequency within COPD
patients and it has been observed that patients with a higher COPD exacerbation
frequency have a higher risk of cardiac events. A greater understanding of
comorbidities, their prevalence, severity, management and incidence over time
in a primary care COPD population; as well as correlation with COPD
exacerbations, forced expiratory volume in 1 second (FEV1) and health-related
quality of life (HRQL), can inform on optimal management of COPD in general
practice.
Study objective
The primary objective of this study is:
• To compare the rate of moderate-severe COPD exacerbations in COPD patients
with and without cardiovascular diseases (CVD)
The secondary objectives are:
• To compare the rate of moderate-severe COPD exacerbations in COPD patients
with and without other defined comorbidities
• To characterize the prevalence, severity and incidence over time of
comorbidities in a primary care COPD population
• To evaluate the relationship between CVD/other comorbidities and FEV1 decline
• To evaluate the relationship between CVD/other comorbidities and EQ-5D
• To evaluate the relationship between CVD/other comorbidities and COPD
Assessment Test* (CAT) scores
• To evaluate the longitudinal properties of the CAT in a primary care setting
An additional objective is:
• To evaluate the relationship between CVD and COPD exacerbations recovery time
(time to recover to normal activity)
Study design
A prospective, observational, non-drug interventional, non-randomized study.
Study burden and risks
Burden description:
Patients will have to fill out questionnaires during 4 visits (11
questionnaires in total), they will have 2 bloodsamples taken (ca. 20 mL in
total), vital signs measured twice, ECG performed twice, longfunction (incl.
reversibility) measured 2-3 times.
Risk assessment:
Small to none. There is no investigational product in this study, hence no
adverse events are to be expected in this regard. . Drawing a bloodsample can
be painful and leave a bruise. Measuring spirometry may lead to difficulty in
breathing. The brochodilator that will be adminisered during spirometry
(Ventolin) will have a small chance of temporary adverse events.
There is a possible benefit that subjects will have their health status
monitored more closely by their general practicioner, who can intervein earlier
if necessary if anything is identified.
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Huis ter Heideweg 62
Zeist 3705 LZ
NL
Listed location countries
Age
Inclusion criteria
1. Males/females >= 40 years of age.
2. COPD (all GOLD-stages) diagnosed >= 12 months ago.
3. FEV1/FVC (tiffeneau-index) after use of bronchodilator < 0.70.
4. Smoking history of >= 10 packyears
5. Singed informed consent form.
Exclusion criteria
1.In the opinion of the investigator, there is a current primary diagnosis of asthma (patients with a primary diagnosis of COPD but who also have asthma may be included)
2.A diagnosis of fibrosis or asbestosis
3.Diagnosis of cancer - includes current and within the last 5 years (patients in remission for >= 5 years may be included). Patients diagnosed with cancer during the study will be withdrawn
4.Diagnosis of clinically significant bronchiectasis
5.Subjects who are concurrently participating in any clinical study or who have received any investigational drugs within 4 weeks of Visit 1, or who will start any during the study period.
6.Unable to or unwilling to conform with the study requirements including completion of the health status questionnaires
7.Females who are pregnant or lactating.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL37931.060.11 |
| Other | nog niet bekend, wordt via openbare database op http://www.gsk-clinicalstudyregister.com/ geregistreerd |