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

Tracking Information
First Received Date ^ICMJE	December 21, 2010
Last Updated Date	August 8, 2011
Start Date ^ICMJE	January 2010
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: December 23, 2010)	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)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01266395 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 23, 2010)	Assess comorbidities as a risk factor for frequent exacerbations [ Time Frame: Retrospective, (previous 24 months) ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Impact of Morning Symptoms in Clinical Control of Chronic Obstructive Pulmonary Disease (COPD)
Official Title ^ICMJE	Impact of Morning Symptoms in Clinical Control of COPD
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 Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	General Practitioners and pneumologist
Condition ^ICMJE	COPD
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1268
Completion Date	July 2011
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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%
Gender	Both
Ages	40 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT01266395
Other Study ID Numbers ^ICMJE	NIS-RES-DUM-2010/2
Has Data Monitoring Committee	No
Responsible Party	MC MD, AstraZeneca
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	August 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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