Assessment of Comorbidities in COPD in European Symptomatic Subjects from primary care.

Completed

Conditions: COPD
lung emphysema
10038716

Registration Number: NL-OMON39121

Lead Sponsor: GlaxoSmithKline

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 480

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 Patients diagnosed with cancer during the study will be withdrawn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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• Rate of COPD exacerbations (moderate-severe severity), based on a healthcare<br /><br>utilisation defined as a worsening of symptoms that require oral<br /><br>corticosteroids and/or antibiotics and/or hospitalizations<br /><br>• Presence and severity of pre-defined cardiovascular diseases</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Presence and severity of other treated comorbidities<br /><br>• Spirometry measurements - FEV1, forced vital capacity (FVC), FEV1/FVC ratio<br /><br>• Health status scores - CAT; EQ-5D; Hospital Anxiety and Depression Scale<br /><br>(HADS); Epworth Sleepiness Scale (ESS); Frequency Scale for the Symptoms of<br /><br>Gastro-oesophageal reflux disease (FSSG)<br /><br>• Medical Research Council (MRC) scores<br /><br>• Number of deaths<br /><br>• Healthcare utilisation: number of unscheduled GP contacts and<br /><br>hospitalisations<br /><br>• Blood chemistry, including glucose; Haemoglobin A1C (HbA1c);; low density<br /><br>lipoprotein (LDL-c), High density lipoprotein (HDL-c), Total cholesterol;<br /><br>triglycerides, prohormone natiuretice peptide (pro-BNP); high-sensitivity C<br /><br>reactive protein (hs-CRP); protein; full blood count<br /><br>• Blood pressure and electrocardiogram (ECG)<br /><br>• Number of bone fractures</p><br>