COPDIMPAEPOCNCT01266395

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

An observational study of COPD, run by AstraZeneca at 52 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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… Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: COPD
How many people: 1,268 participants
Where: 52 sitesSpain
Study dates: Jan 2010to Jul 2011
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: General Practitioners and pneumologist

Who may be able to join

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)

Who cannot join

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%

Trial locations and contacts

52 sites in 1 country.

City, postcode or hospital

52 sites in 1 country

Spain52 sites

Research Site
A Picota (mazaricos), Coruna
Research Site
Abadin (casco Urbano), Lugo
Research Site
Alcalá de Henares, Madrid
Research Site
Alcorcón, Madrid
Research Site
Almería, Almeria
Research Site
Arguineguín, Las Palmas
Research Site
Arriondas, Principality of Asturias
Research Site
Ávila, Avila
Research Site
Badajoz, Badajoz
Research Site
Baralla (casco Urbano), Lugo
Research Site
Barcelona, Barcelona
Research Site
Benaguasil, Valencia
Research Site
Burjassot, Valencia
Research Site
Cangas de Narcea, Principality of Asturias
Research Site
Carballo (carballo), Coruna
Research Site
Castellon, Castellon
Research Site
Cieza, Murcia
Research Site
Donostia / San Sebastian, Guipuzcoa
Research Site
Dos Hermanas, Sevilla
Research Site
El Hospitalet de Llobregat, Barcelona
Research Site
Elda, Alicante
Research Site
Espelúy, Jaen
Research Site
Ferrol, Coruna
Research Site
Guadalajara, Guadalajara
Research Site
Inca, Balearic Islands
Research Site
Jarrio, Principality of Asturias
Research Site
La Pobla de Vallbona, Valencia
Research Site
Leiro (capital), Ourense
Research Site
Lucena, Cordoba
Research Site
Lugo, Lugo
Research Site
Madrid, Madrid
Research Site
Murcia, Murcia
Research Site
Mures, Jaen
Research Site
Nájera, La Rioja
Research Site
Oviedo, Principality of Asturias
Research Site
Pamplona, Navarre
Research Site
Pea'arroya-pueblonuevo, Cordoba
Research Site
Petrel, Alicante
Research Site
Placencia de Las Armas-soraluz, Guipuzcoa
Research Site
Puerto Real, CAdiz
Research Site
San Sebastián de los Reyes, Madrid
Research Site
Santiago de Compostela, Coruna
Research Site
Seville, Sevilla
Research Site
Son Ferriol, Balearic Islands
Research Site
Torreblanca, Castellon
Research Site
Valencia, Valencia
Research Site
Vigo, Pontevedra
Research Site
Villanueva del Ariscal, Sevilla
Research Site
Vinaròs, Castellon
Research Site
Vitoria-Gasteiz, Alava
Research Site
Viveiro (casco Urbano), Lugo
Research Site
Zaragoza, Zaragoza

Other trials in Spain

About this study

Official title: Impact of Morning Symptoms in Clinical Control of COPD

Conditions: COPD
Keywords: morning symptoms COPD
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Retrospective, (previous 24 months)

Secondary outcomes (1)

Assess comorbidities as a risk factor for frequent exacerbations
Measured: Retrospective, (previous 24 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Jul 2011

First posted24 Dec 2010 (estimated)
Study startJan 2010
Study completionJul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COPDStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Cross-sectional
Enrolment: 1,268 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01266395
Sponsor's protocol ID: NIS-RES-DUM-2010/2
Acronym: IMPAEPOC
Status last verified: Aug 2011
First submitted: 21 Dec 2010
Last updated: 9 Aug 2011
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Morning Symptoms in Clinical Control of COPD
ClinicalTrials.gov ID: NCT01266395
Acronym / sponsor ID: IMPAEPOC / NIS-RES-DUM-2010/2
Conditions: COPD
Keywords: morning symptoms COPD
Study type: Observational
Recruitment status: Completed
Enrolment: 1,268 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jan 2010
Study completion: Jul 2011 (actual)
First posted: 24 Dec 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Time perspective: Cross-sectional

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: General Practitioners and pneumologist

Key inclusion criteria (5 listed)

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:

Key exclusion criteria (3 listed)

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%

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

1 secondary outcome

Assess comorbidities as a risk factor for frequent exacerbations
Time frame: Retrospective, (previous 24 months)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2011.

Related trials for COPD

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

52 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COPD, run by AstraZeneca at 52 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Retrospective, (previous 24 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01266395.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2011.