Text Size

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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01266395
First received: December 21, 2010
Last updated: August 8, 2011
Last verified: August 2011
History of Changes
  Purpose

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))


Condition
COPD

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Impact of Morning Symptoms in Clinical Control of COPD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 [ Time Frame: Retrospective, (previous 24 months) ] [ Designated as safety issue: No ]
    Capacity of Daily Living during the Morning Qustionnaire (CDLMQ), Global Chest Symptoms Questionnaire (GCSQ)and COPD Control Questionnaire (CCQ)


Secondary Outcome Measures:
  • Assess comorbidities as a risk factor for frequent exacerbations [ Time Frame: Retrospective, (previous 24 months) ] [ Designated as safety issue: No ]

Enrollment: 1268
Study Start Date: January 2010
Study Completion Date: July 2011
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

General Practitioners and pneumologist

Criteria

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%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266395

  Show 52 Study Locations
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01266395     History of Changes
Other Study ID Numbers: NIS-RES-DUM-2010/2
Study First Received: December 21, 2010
Last Updated: August 8, 2011
Health Authority: Spain: Ethics Committee, Spanish Agency of Medicines

Keywords provided by AstraZeneca:
morning symptoms COPD

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013