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

COPD Clinical Trial

— IMPAEPOC  

Official title:

Impact of Morning Symptoms in Clinical Control of COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01266395
• Other study ID #: NIS-RES-DUM-2010/2
• Status: Completed
• Phase: N/A
• First received: December 21, 2010
• Last updated: August 8, 2011
• Start date: January 2010
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee, Spanish Agency of Medicines
• Study type: Observational

Clinical Trial 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))

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1268
• Est. completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Spain	Research Site	A Picota (mazaricos)	Coruna
Spain	Research Site	Abadin (casco Urbano)	Lugo
Spain	Research Site	Alcala de Henares	Madrid
Spain	Research Site	Alcorcon	Madrid
Spain	Research Site	Almeria
Spain	Research Site	Arguineguin	Las Palmas
Spain	Research Site	Arriondas	Asturias
Spain	Research Site	Avila
Spain	Research Site	Badajoz
Spain	Research Site	Baralla (casco Urbano)	Lugo
Spain	Research Site	Barcelona
Spain	Research Site	Benaguasil	Valencia
Spain	Research Site	Burjassot	Valencia
Spain	Research Site	Cangas de Narcea	Asturias
Spain	Research Site	Carballo (carballo)	Coruna
Spain	Research Site	Castellon de La Plana	Castellon
Spain	Research Site	Cieza	Murcia
Spain	Research Site	Dos Hermanas	Sevilla
Spain	Research Site	El Hospitalet de Llobregat	Barcelona
Spain	Research Site	Elda	Alicante
Spain	Research Site	Espeluy	Jaen
Spain	Research Site	Ferrol	Coruna
Spain	Research Site	Guadalajara
Spain	Research Site	Inca	Illes Balears
Spain	Research Site	Jarrio	Asturias
Spain	Research Site	La Pobla de Vallbona	Valencia
Spain	Research Site	Leiro (capital)	Ourense
Spain	Research Site	Lucena	Cordoba
Spain	Research Site	Lugo
Spain	Research Site	Madrid
Spain	Research Site	Murcia
Spain	Research Site	Mures	Jaen
Spain	Research Site	Najera	La Rioja
Spain	Research Site	Oviedo	Asturias
Spain	Research Site	Pamplona	Navarra
Spain	Research Site	Pea'arroya-pueblonuevo	Cordoba
Spain	Research Site	Petrer	Alicante
Spain	Research Site	Placencia de Las Armas-soraluz	Guipuzcoa
Spain	Research Site	Puerto Real	CAdiz
Spain	Research Site	San Sebastian	Guipuzcoa
Spain	Research Site	San Sebastian de Los Reyes	Madrid
Spain	Research Site	Santiago de Compostela	Coruna
Spain	Research Site	Sevilla
Spain	Research Site	Son Ferriol	Illes Balears
Spain	Research Site	Torreblanca	Castellon
Spain	Research Site	Valencia
Spain	Research Site	Vigo	Pontevedra
Spain	Research Site	Villanueva Del Ariscal	Sevilla
Spain	Research Site	Vinaros	Castellon
Spain	Research Site	Vitoria	Alava
Spain	Research Site	Viveiro (casco Urbano)	Lugo
Spain	Research Site	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Assess comorbidities as a risk factor for frequent exacerbations		Retrospective, (previous 24 months)	No