Clinical trial NCT01266395: Impact of Morning Symptoms in Clinical Control of Chronic Obstructive Pulmonary Disease (COPD)
Official title: Impact of Morning Symptoms in Clinical Control of COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: morning symptoms COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-12-24
Enrollment: 1268
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: General Practitioners and pneumologist

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))


Eligibility 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%

Primary outcomes:
measure: 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
timeFrame: Retrospective, (previous 24 months)
Secondary outcomes:
measure: Assess comorbidities as a risk factor for frequent exacerbations
timeFrame: Retrospective, (previous 24 months)
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Research Site
state: Alava
city: Elda
country: Spain
facility: Research Site
state: Alicante
city: Petrer
country: Spain
facility: Research Site
state: Alicante
city: Arriondas
country: Spain
facility: Research Site
state: Asturias
city: Cangas de Narcea
country: Spain
facility: Research Site
state: Asturias
city: Jarrio
country: Spain
facility: Research Site
state: Asturias
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: El Hospitalet de Llobregat
country: Spain
facility: Research Site
state: Barcelona
city: Puerto Real
country: Spain
facility: Research Site
state: CAdiz
city: Castellon de La Plana
country: Spain
facility: Research Site
state: Castellon
city: Torreblanca
country: Spain
facility: Research Site
state: Castellon
city: Vinaros
country: Spain
facility: Research Site
state: Castellon
city: Lucena
country: Spain
facility: Research Site
state: Cordoba
city: Pea'arroya-pueblonuevo
country: Spain
facility: Research Site
state: Cordoba
city: A Picota (mazaricos)
country: Spain
facility: Research Site
state: Coruna
city: Carballo (carballo)
country: Spain
facility: Research Site
state: Coruna
city: Ferrol
country: Spain
facility: Research Site
state: Coruna
city: Santiago de Compostela
country: Spain
facility: Research Site
state: Coruna
city: Placencia de Las Armas-soraluz
country: Spain
facility: Research Site
state: Guipuzcoa
city: San Sebastian
country: Spain
facility: Research Site
state: Guipuzcoa
city: Inca
country: Spain
facility: Research Site
state: Illes Balears
city: Son Ferriol
country: Spain
facility: Research Site
state: Illes Balears
city: Espeluy
country: Spain
facility: Research Site
state: Jaen
city: Mures
country: Spain
facility: Research Site
state: Jaen
city: Najera
country: Spain
facility: Research Site
state: La Rioja
city: Arguineguin
country: Spain
facility: Research Site
state: Las Palmas
city: Abadin (casco Urbano)
country: Spain
facility: Research Site
state: Lugo
city: Baralla (casco Urbano)
country: Spain
facility: Research Site
state: Lugo
city: Viveiro (casco Urbano)
country: Spain
facility: Research Site
state: Lugo
city: Alcala de Henares
country: Spain
facility: Research Site
state: Madrid
city: Alcorcon
country: Spain
facility: Research Site
state: Madrid
city: San Sebastian de Los Reyes
country: Spain
facility: Research Site
state: Madrid
city: Cieza
country: Spain
facility: Research Site
state: Murcia
city: Pamplona
country: Spain
facility: Research Site
state: Navarra
city: Leiro (capital)
country: Spain
facility: Research Site
state: Ourense
city: Vigo
country: Spain
facility: Research Site
state: Pontevedra
city: Dos Hermanas
country: Spain
facility: Research Site
state: Sevilla
city: Villanueva Del Ariscal
country: Spain
facility: Research Site
state: Sevilla
city: Benaguasil
country: Spain
facility: Research Site
state: Valencia
city: Burjassot
country: Spain
facility: Research Site
state: Valencia
city: La Pobla de Vallbona
country: Spain
facility: Research Site
state: Valencia
city: Almeria
country: Spain
facility: Research Site
city: Avila
country: Spain
facility: Research Site
city: Badajoz
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Guadalajara
country: Spain
facility: Research Site
city: Lugo
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
Study officials:
References: