Chronic Obstructive Pulmonary DiseaseVITALITENCT01007734
Factors Determining Quality of Life Related to Respiratory Status According to Gender of Chronic Obstructive Pulmonary Disease (COPD) Patients
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 178 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 449 participants
- Where
- 178 sitesFrance
- Study dates
- Oct 2009to Jul 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: First 3 consecutive adults with COPD with at least a three month follow up, seen by pneumologist
Who may be able to join
- Adult patient who has a clinical visit for their usual follow-up.
- patient with COPD with at least a three month follow up
Who cannot join
- Current or history of asthma
- Current participation in an interventional clinical study
Trial locations and contacts
178 sites in 1 country.
178 sites in 1 country
France178 sites
Research Site
Abbeville
Research Site
Agde
Research Site
Agen
Research Site
Aix-en-Provence
Research Site
Ajaccio
Research Site
Albi
Research Site
Alençon
Research Site
Alès
Research Site
Ambilly
Research Site
Amelie Les Bains Palalda
Research Site
Amiens
Research Site
Angers
Research Site
Angoulême
Research Site
Annecy
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Antibes
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Antony
Research Site
Armentières
Research Site
Auch
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Bagneux
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Bastia
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Bayonne
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Beauvais
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Belfort
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Berck
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Besançon
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Béthune
Research Site
Beuvry
Research Site
Béziers
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Bois-Guillaume
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Bonneville
Research Site
Bordeaux
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Bourges
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Bourgoin
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Brest
Research Site
Briey
Research Site
Brive-la-Gaillarde
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Cachan
Research Site
Caen
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Cagnes-sur-Mer
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Calais
Research Site
Cambo-les-Bains
Research Site
Cambrai
Research Site
Cannes
Research Site
Castelnau-le-Lez
Research Site
Cavaillon
Research Site
Challans
Research Site
Chalon-sur-Saône
Research Site
Châlons-en-Champagne
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Chamalières
Research Site
Chambéry
Research Site
Charleville-Mézières
Research Site
Cherbourg Octeville
Research Site
Cholet
Research Site
Clermont-Ferrand
Research Site
Cluses
Research Site
Cognac
Research Site
Colmar
Research Site
Corbeil-Essonnes
Research Site
Courbevoie
Research Site
Croix
Research Site
Denain
Research Site
Divion
Research Site
Écully
Research Site
Épernay
Research Site
Facture
Research Site
Figeac
Research Site
Fleury-les-Aubrais
Research Site
Foix
Research Site
Fontenay-le-Comte
Research Site
Fréjus
Research Site
Gap
Research Site
Givors
Research Site
Grande-Synthe
Research Site
Grenoble
Research Site
Guingamp
Research Site
Hagondange
Research Site
Herblay-sur-Seine
Research Site
Hyères
Research Site
Istres
Research Site
Jonzac
Research Site
Juan-les-Pins
Research Site
Juvisy-sur-Orge
Research Site
La Ferté-Bernard
Research Site
La Rochelle
Research Site
La Teste-de-Buch
Research Site
Lagny-sur-Marne
Research Site
Laon
Research Site
Le Cannet
Research Site
Le Chesnay
Research Site
Lège-Cap-Ferret
Research Site
Lens
Research Site
Libourne
Research Site
Liévin
Research Site
Lille
Research Site
Limoges
Research Site
LIsle-dEspagnac
Research Site
Lodève
Research Site
Lorient
Research Site
Lormont
Research Site
Lutterbach
Research Site
Lyon
Research Site
Maisons-Alfort
Research Site
Maisons-Laffitte
Research Site
Mandelieu-la-Napoule
Research Site
Marignane
Research Site
Marly-le-Roi
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Marmande
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Marseille
Research Site
Melun
Research Site
Mende
Research Site
Millau
Research Site
Molsheim
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Montauban
Research Site
Montbéliard
Research Site
Montfermeil
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Montgeron
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Montigny-lès-Metz
Research Site
Montpellier
Research Site
Nancy
Research Site
Nans-les-Pins
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Nantes
Research Site
Narbonne
Research Site
Nevers
Research Site
Nice
Research Site
Nîmes
Research Site
Niort
Research Site
Nogent-sur-Marne
Research Site
Ollioules
Research Site
Oloron-Sainte-Marie
Research Site
Orléans
Research Site
Paris
Research Site
Perpignan
Research Site
Pessac
Research Site
Pézenas
Research Site
Poitiers
Research Site
Pontault-Combault
Research Site
Pontivy
Research Site
Reims
Research Site
Rennes
Research Site
Rouen
Research Site
Royan
Research Site
Rueil-Malmaison
Research Site
Saint-André-les-Vergers
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Saint-Brieuc
Research Site
Saint-Denis
Research Site
Saint-Estève
Research Site
Saint-Etienne
Research Site
Saint-Girons
Research Site
Saint-Jean-de-Maurienne
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Saint-Julien-de-Raz
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Saint-Martin-Boulogne
Research Site
Saint-Martin-d'Hères
Research Site
Saint-Orens-de-Gameville
Research Site
Saint-Quentin
Research Site
Sarlat-la-Canéda
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Sélestat
Research Site
Sens
Research Site
St-Malo
Research Site
St.-Jean
Research Site
Ste Clotilde Cedex
Research Site
Strasbourg
Research Site
Taden
Research Site
Tergnier
Research Site
Thionville
Research Site
Thonon-les-Bains
Research Site
Thouars
Research Site
Toulon
Research Site
Toulouse
Research Site
Tourcoing
Research Site
Tours
Research Site
Valence
Research Site
Valenciennes
Research Site
Vénissieux
Research Site
Vienne
Research Site
Vierzon
Research Site
Villefranche-de-Lauragais
Research Site
Villefranche-sur-Saône
Research Site
Villeurbanne
About this study
Official title: 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Quality of life, COPD patients, Evaluation According to Gender the Determining Independent Factors of Quality of Life Related to Respiratory Status of Patient With Moderate to Severe COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 449 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alain Alain Castaigne, Medical Director, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007734
- Sponsor's protocol ID
- NIS-RFR-DUM-2009/1
- Acronym
- VITALITE
- Status last verified
- Jul 2010
- First submitted
- 31 Oct 2009
- Last updated
- 27 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Determining Quality of Life Related to Respiratory Status According to Gender of COPD Patients Followed by a Pneumologist
- ClinicalTrials.gov ID
- NCT01007734
- Acronym / sponsor ID
- VITALITE / NIS-RFR-DUM-2009/1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Quality of life, COPD patients, Evaluation According to Gender the Determining Independent Factors of Quality of Life Related to Respiratory Status of Patient With Moderate to Severe COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 449 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 4 Nov 2009 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- First 3 consecutive adults with COPD with at least a three month follow up, seen by pneumologist
Key inclusion criteria (2 listed)
- Adult patient who has a clinical visit for their usual follow-up.
- patient with COPD with at least a three month follow up
Key exclusion criteria (2 listed)
- Current or history of asthma
- Current participation in an interventional clinical study
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
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
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 27 Jul 2010.
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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.
Alain Alain Castaigne, Medical Director study director
AstraZeneca
178 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 178 sites in France.
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 2 inclusion and 2 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 27 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 178 sites in France. 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?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2010.