Impact of Morning Symptoms in Clinical Control of Chronic Obstructive Pulmonary Disease (COPD)

Completed

• Conditions: COPD

• Registration Number: NCT01266395
• Lead Sponsor: AstraZeneca

Brief Summary

Observational study to know the Impact of morning symptoms in clinical control of COPD patients. 1200 patients will be included by General practitioners (GPs) and pneumologists. Objective: establish if there are differences in the impact of COPD on daily activities and morning symptoms measured through questionnaires of daily life activity (Capacity of Daily Living during the Morning (CDLM), Global Chest Symptoms Questionnaire (GCSQ))

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-12-21
• Study First Submitted QC: 2010-12-23
• Study First Posted: 2010-12-24
• Study Completion: 2011-07
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-08
• Last Update Posted: 2011-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1268

Inclusion Criteria

• Patient has signed informed consent form

• Patients of both sexes,> 40 years.

• Patients diagnosed with COPD according to global consensus on the definition, classification and management of the disease (GOLD) criteria:

  • post-bronchodilator forced expiratory volume in 1 s (FEV1) / forced vital capacity (FVC) <70%
  • post-bronchodilator FEV1 <80% (stage II, III and IV)

Exclusion Criteria

• Participating in an epidemiological study or clinical trial
• Patient with other respiratory disease than COPD (eg bronchial asthma, cystic fibrosis, severe bronchiectasis, restrictive lung disease, cancer, etc.).
• Patients with mild COPD: FEV1> 80%

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine if there are differences in the impact of COPD on patients according to the characteristics of the disease. To measure the impact of specific self-administered questionnaires used in COPD: CDLMQ, GCSQ and CCQ	Retrospective, (previous 24 months)	Capacity of Daily Living during the Morning Qustionnaire (CDLMQ), Global Chest Symptoms Questionnaire (GCSQ)and COPD Control Questionnaire (CCQ)

Secondary Outcome Measures

Name	Time	Method
Assess comorbidities as a risk factor for frequent exacerbations	Retrospective, (previous 24 months)

Trial Locations

Locations (1)

Research Site; 🇪🇸 Zaragoza, Spain