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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39121

Enrollment

480

Registered

2011-11-11

Start date

2011-12-02

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD lung emphysema

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 = 10 packyears 5. Singed informed consent form.

Exclusion criteria

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 Patients diagnosed with cancer during the study will be withdrawn 4.Diagnosis of clinically significant bronchiectasis 5.Subjects who are concurrently participating in any clinical study or who have received any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 outcomes

Primary

Measure	Time frame
• 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

Measure	Time frame
• 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	—

Measure

Time frame

• 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

—

Countries

Netherlands

Outcome results