Factors Determining Quality of Life Related to Respiratory Status According to Gender of Chronic Obstructive Pulmonary Disease (COPD) Patients (VITALITE)

July 26, 2010 updated by: AstraZeneca

Factors Determining Quality of Life Related to Respiratory Status According to Gender of COPD Patients Followed by a Pneumologist

The purpose of this study is to evaluate with sufficient precision and according to gender the determining independent factors of quality of life related to respiratory status of patient with moderate to severe COPD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
449

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Abbeville, France
        • Research Site
      • Agde, France
        • Research Site
      • Agen, France
        • Research Site
      • Aix En Provence, France
        • Research Site
      • Ajaccio, France
        • Research Site
      • Albi, France
        • Research Site
      • Alencon, France
        • Research Site
      • Ales, France
        • Research Site
      • Ambilly, France
        • Research Site
      • Amelie Les Bains Palalda, France
        • Research Site
      • Amiens, France
        • Research Site
      • Angers, France
        • Research Site
      • Angouleme, France
        • Research Site
      • Annecy, France
        • Research Site
      • Antibes, France
        • Research Site
      • Antony Cedex, France
        • Research Site
      • Armentieres, France
        • Research Site
      • Auch, France
        • Research Site
      • Bagneux, France
        • Research Site
      • Bastia, France
        • Research Site
      • Bayonne, France
        • Research Site
      • Beauvais Cedex, France
        • Research Site
      • Belfort, France
        • Research Site
      • Berck Cedex, France
        • Research Site
      • Besancon, France
        • Research Site
      • Bethune, France
        • Research Site
      • Beuvry, France
        • Research Site
      • Beziers, France
        • Research Site
      • Bois Guillaume, France
        • Research Site
      • Bonneville, France
        • Research Site
      • Bordeaux, France
        • Research Site
      • Bourges, France
        • Research Site
      • Bourgoin Jallieu, France
        • Research Site
      • Brest, France
        • Research Site
      • Briey Cedex, France
        • Research Site
      • Brive La Gaillarde, France
        • Research Site
      • Cachan, France
        • Research Site
      • Caen Cedex 4, France
        • Research Site
      • Cagnes Sur Mer, France
        • Research Site
      • Calais Cedex, France
        • Research Site
      • Cambo Les Bains, France
        • Research Site
      • Cambrai, France
        • Research Site
      • Cannes, France
        • Research Site
      • Castelnau Le Lez Cedex, France
        • Research Site
      • Cavaillon, France
        • Research Site
      • Challans, France
        • Research Site
      • Chalon Sur Saone, France
        • Research Site
      • Chalons En Champagne Cedex, France
        • Research Site
      • Chamalieres, France
        • Research Site
      • Chambery, France
        • Research Site
      • Charleville Mezieres, France
        • Research Site
      • Cherbourg Octeville, France
        • Research Site
      • Cholet, France
        • Research Site
      • Clermont Ferrand, France
        • Research Site
      • Cluses, France
        • Research Site
      • Cognac, France
        • Research Site
      • Colmar, France
        • Research Site
      • Corbeil Essonnes, France
        • Research Site
      • Corbeil Essonnes Cedex, France
        • Research Site
      • Courbevoie, France
        • Research Site
      • Croix, France
        • Research Site
      • Denain Cedex, France
        • Research Site
      • Divion, France
        • Research Site
      • Ecully, France
        • Research Site
      • Epernay, France
        • Research Site
      • Facture, France
        • Research Site
      • Figeac, France
        • Research Site
      • Fleury Les Aubrais, France
        • Research Site
      • Foix, France
        • Research Site
      • Fontenay Le Comte, France
        • Research Site
      • Frejus, France
        • Research Site
      • GAP, France
        • Research Site
      • Givors Cedex, France
        • Research Site
      • Grande Synthe, France
        • Research Site
      • Grenoble Cedex 1, France
        • Research Site
      • Guingamp, France
        • Research Site
      • Hagondange, France
        • Research Site
      • Herblay, France
        • Research Site
      • Hyeres, France
        • Research Site
      • Istres, France
        • Research Site
      • Jonzac Cedex, France
        • Research Site
      • Juan Les Pins, France
        • Research Site
      • Juvisy Sur Orge Cedex, France
        • Research Site
      • L Isle D Espagnac, France
        • Research Site
      • La Ferte Bernard, France
        • Research Site
      • La Rochelle, France
        • Research Site
      • La Teste de Buch, France
        • Research Site
      • Lagny Sur Marne Cedex, France
        • Research Site
      • Laon, France
        • Research Site
      • Le Cannet, France
        • Research Site
      • Le Chesnay, France
        • Research Site
      • Lege Cap Ferret, France
        • Research Site
      • Lens Cedex, France
        • Research Site
      • Libourne, France
        • Research Site
      • Lievin Cedex, France
        • Research Site
      • Lille, France
        • Research Site
      • Limoges, France
        • Research Site
      • Lodeve, France
        • Research Site
      • Lorient, France
        • Research Site
      • Lormont, France
        • Research Site
      • Lutterbach, France
        • Research Site
      • Lyon, France
        • Research Site
      • Maisons Alfort, France
        • Research Site
      • Maisons Laffitte Cedex, France
        • Research Site
      • Mandelieu La Napoule, France
        • Research Site
      • Marignane, France
        • Research Site
      • Marly Le Roi, France
        • Research Site
      • Marmande, France
        • Research Site
      • Marseille, France
        • Research Site
      • Melun, France
        • Research Site
      • Mende, France
        • Research Site
      • Millau, France
        • Research Site
      • Molsheim, France
        • Research Site
      • Montauban, France
        • Research Site
      • Montauban Cedex, France
        • Research Site
      • Montbeliard, France
        • Research Site
      • Montfermeil, France
        • Research Site
      • Montgeron, France
        • Research Site
      • Montigny Les Metz, France
        • Research Site
      • Montpellier, France
        • Research Site
      • Nancy, France
        • Research Site
      • Nans Les Pins, France
        • Research Site
      • Nantes, France
        • Research Site
      • Narbonne, France
        • Research Site
      • Nevers, France
        • Research Site
      • Nice, France
        • Research Site
      • Nimes Cedex 9, France
        • Research Site
      • Niort, France
        • Research Site
      • Nogent Sur Marne, France
        • Research Site
      • Ollioules, France
        • Research Site
      • Oloron Ste Marie, France
        • Research Site
      • Orleans, France
        • Research Site
      • Paris, France
        • Research Site
      • Paris Cedex 14, France
        • Research Site
      • Paris Cedex 15, France
        • Research Site
      • Perpignan Cedex, France
        • Research Site
      • Pessac, France
        • Research Site
      • Pezenas, France
        • Research Site
      • Poitiers, France
        • Research Site
      • Pontault Combault, France
        • Research Site
      • Pontivy, France
        • Research Site
      • Reims, France
        • Research Site
      • Reims Cedex, France
        • Research Site
      • Rennes, France
        • Research Site
      • Rouen, France
        • Research Site
      • Royan, France
        • Research Site
      • Rueil Malmaison, France
        • Research Site
      • Sarlat La Caneda, France
        • Research Site
      • Selestat, France
        • Research Site
      • Sens, France
        • Research Site
      • St Andre, France
        • Research Site
      • St Andre Les Vergers, France
        • Research Site
      • St Brieuc Cedex 1, France
        • Research Site
      • St Denis Cedex, France
        • Research Site
      • St Esteve Cedex, France
        • Research Site
      • St Etienne, France
        • Research Site
      • St Girons, France
        • Research Site
      • St Jean, France
        • Research Site
      • St Jean de Maurienne, France
        • Research Site
      • St Julien de Raz, France
        • Research Site
      • St Malo, France
        • Research Site
      • St Martin Boulogne, France
        • Research Site
      • St Martin D Heres, France
        • Research Site
      • St Orens de Gameville, France
        • Research Site
      • St Quentin, France
        • Research Site
      • Ste Clotilde Cedex, France
        • Research Site
      • Strasbourg, France
        • Research Site
      • Taden, France
        • Research Site
      • Tergnier, France
        • Research Site
      • Thionville, France
        • Research Site
      • Thonon Les Bains, France
        • Research Site
      • Thouars Cedex, France
        • Research Site
      • Toulon, France
        • Research Site
      • Toulouse, France
        • Research Site
      • Toulouse Cedex 3, France
        • Research Site
      • Tourcoing, France
        • Research Site
      • Tours, France
        • Research Site
      • Valence, France
        • Research Site
      • Valenciennes Cedex, France
        • Research Site
      • Venissieux, France
        • Research Site
      • Vienne, France
        • Research Site
      • Vierzon, France
        • Research Site
      • Villefranche Sur Saone, France
        • Research Site
      • Villefranche de Lauragais, France
        • Research Site
      • Villeurbanne, France
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

First 3 consecutive adults with COPD with at least a three month follow up, seen by pneumologist

Description

Inclusion Criteria:

  • Adult patient who has a clinical visit for their usual follow-up.
  • patient with COPD with at least a three month follow up

Exclusion Criteria:

  • Current or history of asthma
  • Current participation in an interventional clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
1

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
To evaluate with sufficient precision and according to gender the determining independent factors of quality of life related to respiratory status of patient with moderate to severe COPD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Alain Alain Castaigne, Medical Director, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIS-RFR-DUM-2009/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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