NCT01266395

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))

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,268

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

52 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

August 9, 2011

Status Verified

August 1, 2011

First QC Date

December 21, 2010

Last Update Submit

August 8, 2011

Conditions

Keywords

morning symptoms COPD

Outcome Measures

Primary Outcomes (1)

  • 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

    Capacity of Daily Living during the Morning Qustionnaire (CDLMQ), Global Chest Symptoms Questionnaire (GCSQ)and COPD Control Questionnaire (CCQ)

    Retrospective, (previous 24 months)

Secondary Outcomes (1)

  • Assess comorbidities as a risk factor for frequent exacerbations

    Retrospective, (previous 24 months)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

General Practitioners and pneumologist

You may qualify if:

  • 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)

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (52)

Research Site

Vitoria-Gasteiz, Alava, Spain

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Elda, Alicante, Spain

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Petrel, Alicante, Spain

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Almería, Almeria, Spain

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Ávila, Avila, Spain

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Badajoz, Badajoz, Spain

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Inca, Balearic Islands, Spain

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Son Ferriol, Balearic Islands, Spain

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Barcelona, Barcelona, Spain

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El Hospitalet de Llobregat, Barcelona, Spain

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Puerto Real, CAdiz, Spain

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Castellon, Castellon, Spain

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Torreblanca, Castellon, Spain

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Vinaròs, Castellon, Spain

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Lucena, Cordoba, Spain

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Pea'arroya-pueblonuevo, Cordoba, Spain

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A Picota (mazaricos), Coruna, Spain

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Carballo (carballo), Coruna, Spain

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Ferrol, Coruna, Spain

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Santiago de Compostela, Coruna, Spain

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Guadalajara, Guadalajara, Spain

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Donostia / San Sebastian, Guipuzcoa, Spain

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Placencia de Las Armas-soraluz, Guipuzcoa, Spain

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Espelúy, Jaen, Spain

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Mures, Jaen, Spain

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Nájera, La Rioja, Spain

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Arguineguín, Las Palmas, Spain

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Abadin (casco Urbano), Lugo, Spain

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Baralla (casco Urbano), Lugo, Spain

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Lugo, Lugo, Spain

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Viveiro (casco Urbano), Lugo, Spain

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Alcalá de Henares, Madrid, Spain

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Alcorcón, Madrid, Spain

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Madrid, Madrid, Spain

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San Sebastián de los Reyes, Madrid, Spain

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Cieza, Murcia, Spain

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Murcia, Murcia, Spain

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Pamplona, Navarre, Spain

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Leiro (capital), Ourense, Spain

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Vigo, Pontevedra, Spain

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Arriondas, Principality of Asturias, Spain

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Cangas de Narcea, Principality of Asturias, Spain

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Jarrio, Principality of Asturias, Spain

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Oviedo, Principality of Asturias, Spain

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Dos Hermanas, Sevilla, Spain

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Seville, Sevilla, Spain

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Villanueva del Ariscal, Sevilla, Spain

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Benaguasil, Valencia, Spain

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Burjassot, Valencia, Spain

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La Pobla de Vallbona, Valencia, Spain

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Valencia, Valencia, Spain

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Zaragoza, Zaragoza, Spain

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 21, 2010

First Posted

December 24, 2010

Study Start

January 1, 2010

Study Completion

July 1, 2011

Last Updated

August 9, 2011

Record last verified: 2011-08

Locations