AsthmaSAISONNCT00882128

Evaluation of the Control Level of Asthmatic Patients With Seasonal Increase of Respiratory Symptoms (High and/or Low)

An observational study of Asthma and Respiratory Symptoms, run by AstraZeneca at 1,051 sites in France.

Completed

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

Trial summary

To evaluate the level of control of Asthma (GINA : controlled, partially controlled, not controlled) of asthmatic patients consulting their general practitioner for a seasonal increase of respiratory symptoms (high and / or low) whether an inhaled corticotherapy is taken or not. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma, Respiratory Symptoms
How many people: 3,300 participants
Where: 1,051 sitesFrance
Study dates: May 2009to Oct 2009
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: The first 3 consecutive adult and asthmatic patients consulting their general practitioner for a seasonal increase of respiratory symptoms (high and / or low) and treated with PRN fast acting bronchodilatator alone or associated with inhaled IGCS, excluding all other treatments for asthma.

Who may be able to join

Asthmatic adults consulting for a seasonal increase of respiratory symptoms (high/low) and treated with PRN fast acting bronchodilator alone or associated with inhaled IGCS, excluding all other treatments for asthma.

Who cannot join

None listed.

Trial locations and contacts

1,051 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

France300 sites

Research Site
Abbaretz
Research Site
Acheux-en-Amiénois
Research Site
Agen
Research Site
Agneaux
Research Site
Agon-Coutainville
Research Site
Aignay-le-Duc
Research Site
Aiguillon
Research Site
Aiserey
Research Site
Aix-en-Provence
Research Site
Aix-les-Bains
Research Site
Ajaccio
Research Site
Albi
Research Site
Alençon
Research Site
Alès
Research Site
Alleins
Research Site
Allonnes
Research Site
Althen-des-Paluds
Research Site
Amagne
Research Site
Ambert
Research Site
Ambès
Research Site
Andance
Research Site
Andard
Research Site
Anizy-le-Château
Research Site
Annay
Research Site
Antibes
Research Site
Antony
Research Site
Anzin
Research Site
Arc-et-Senans
Research Site
Arcachon
Research Site
Arches
Research Site
Argentat
Research Site
Argenteuil
Research Site
Arles
Research Site
Art-sur-Meurthe
Research Site
Arthez-de-Béarn
Research Site
Asnières-sur-Seine
Research Site
Aspiran
Research Site
Aubagne
Research Site
Aubervilliers
Research Site
Auch
Research Site
Auchel
Research Site
Auchy-les-Mines
Research Site
Audincourt
Research Site
Augny
Research Site
Aulnat
Research Site
Aulnay-sous-Bois
Research Site
Aumetz
Research Site
Aurillac
Research Site
Auterive
Research Site
Authon-du-Perche
Research Site
Autun
Research Site
Auxerre
Research Site
Auxi-le-Château
Research Site
Auxonne
Research Site
Auzon
Research Site
Avallon
Research Site
Avignon
Research Site
Avoine
Research Site
Axat
Research Site
Bachant
Research Site
Badevel
Research Site
Bagneux
Research Site
Baignes Ste Radegonde
Research Site
Baigneux-les-Juifs
Research Site
Bailly-Romainvilliers
Research Site
Bains
Research Site
Bais
Research Site
Balan
Research Site
Bannalec
Research Site
Barbezieux-Saint-Hilaire
Research Site
Barentin
Research Site
Basse-Goulaine
Research Site
Bassens
Research Site
Baulon
Research Site
Bayeux
Research Site
Bayonne
Research Site
Beaucaire
Research Site
Beauchamp
Research Site
Beaumesnil
Research Site
Beaumont-de-Pertuis
Research Site
Beaumont-en-Véron
Research Site
Beaumont-sur-Lèze
Research Site
Beautor
Research Site
Beauvais
Research Site
Beauvallon
Research Site
Beauzelle
Research Site
Behren-lès-Forbach
Research Site
Belfort
Research Site
Bellême
Research Site
Bellemene
Research Site
Belleville-sur-Meuse
Research Site
Belz
Research Site
Benquet
Research Site
Bérat
Research Site
Berck
Research Site
Bergbieten
Research Site
Bergholtz
Research Site
Bermerain
Research Site
Berson
Research Site
Besançon
Research Site
Bétaille
Research Site
Béthisy-Saint-Pierre
Research Site
Bethoncourt
Research Site
Béville-le-Comte
Research Site
Béziers
Research Site
Bezons
Research Site
Biganos
Research Site
Billom
Research Site
Biver
Research Site
Blangy-sur-Bresle
Research Site
Blanquefort
Research Site
Blénod-lès-Pont-à-Mousson
Research Site
Bobigny
Research Site
Boëge
Research Site
Boën-sur-Lignon
Research Site
Bois-en-Ardres
Research Site
Bois-le-Roi
Research Site
Bolbec
Research Site
Bollène
Research Site
Bondoufle
Research Site
Bonnelles
Research Site
Bonnières-sur-Seine
Research Site
Boos
Research Site
Bordeaux
Research Site
Bormes-les-Mimosas
Research Site
Bort-les-Orgues
Research Site
Bouffémont
Research Site
Bouguenais
Research Site
Boujan-sur-Libron
Research Site
Boulogne-Billancourt
Research Site
Boulogne-sur-Gesse
Research Site
Boulogne-sur-Mer
Research Site
Bourcefranc-le-Chapus
Research Site
Bourg-en-Bresse
Research Site
Bourg-la-Reine
Research Site
Bourges
Research Site
Bourron-Marlotte
Research Site
Bourth
Research Site
Boves
Research Site
Boynes
Research Site
Branne
Research Site
Brantôme
Research Site
Bréhal
Research Site
Bresles
Research Site
Brest
Research Site
Breteuil
Research Site
Bretteville-l'Orgueilleuse
Research Site
Briançon
Research Site
Brie-Comte-Robert
Research Site
Brignais
Research Site
Brignoles
Research Site
Brive-la-Gaillarde
Research Site
Brunstatt
Research Site
Bruyères-sur-Oise
Research Site
Buc
Research Site
Bulgnéville
Research Site
Bussang
Research Site
Cachan
Research Site
Cagnes-sur-Mer
Research Site
Cahuzac-sur-Vère
Research Site
Calais
Research Site
Calvi
Research Site
Calvisson
Research Site
Camblanes
Research Site
Cambrai
Research Site
Camors
Research Site
Canteleu
Research Site
Cany-Barville
Research Site
Capbreton
Research Site
Capdenac-Gare
Research Site
Cappelle-en-Pévèle
Research Site
Cappelle-la-Grande
Research Site
Carantec
Research Site
Carbon-Blanc
Research Site
Carcassonne
Research Site
Carhaix-Plouguer
Research Site
Carpentras
Research Site
Carquefou
Research Site
Carresse-Cassaber
Research Site
Carvin
Research Site
Castelnau-Montratier
Research Site
Castets-en-Dorthe
Research Site
Caveirac
Research Site
Caylus
Research Site
Celles-sur-Plaine
Research Site
Cérences
Research Site
Cérilly
Research Site
Chabris
Research Site
Chaingy
Research Site
Chalais
Research Site
Chalamont
Research Site
Chaleins
Research Site
Châlons-en-Champagne
Research Site
Chambéry
Research Site
Champagne-sur-Oise
Research Site
Champagne-sur-Seine
Research Site
Champagnole
Research Site
Champcueil
Research Site
Champdeniers-Saint-Denis
Research Site
Champeaux
Research Site
Champigné
Research Site
Champigneulles
Research Site
Champigny-sur-Marne
Research Site
Champs-sur-Marne
Research Site
Chanteheux
Research Site
Chantepie
Research Site
Chantilly
Research Site
Chantonnay
Research Site
Chapelle Saint Martin Plaine
Research Site
Charleville-Mézières
Research Site
Charmes
Research Site
Chartres
Research Site
Chasseneuil-du-Poitou
Research Site
Chassieu
Research Site
Château-d'Olonne
Research Site
Châteaubriant
Research Site
Châteaugay
Research Site
Chateauneuf Ille Vilaine
Research Site
Châteauneuf-sur-Cher
Research Site
Châteauroux
Research Site
Châtelaillon-Plage
Research Site
Châtellerault
Research Site
Châtenay-Malabry
Research Site
Châtenois-les-Forges
Research Site
Châtillon-sur-Colmont
Research Site
Chatte
Research Site
Chauvigny
Research Site
Cherbourg Octeville
Research Site
Cherisy
Research Site
Cherves-Richemont
Research Site
Cheval-Blanc
Research Site
Chinon
Research Site
Choisey
Research Site
Cholet
Research Site
Ciboure
Research Site
Ciry-le-Noble
Research Site
Clairac
Research Site
Clamart
Research Site
Clermont
Research Site
Clermont-Ferrand
Research Site
Clichy
Research Site
Colomars
Research Site
Colombes
Research Site
Colombey-les-Belles
Research Site
Colomiers
Research Site
Combrit
Research Site
Combs-la-Ville
Research Site
Comines
Research Site
Commentry
Research Site
Communay
Research Site
Comps
Research Site
Conflans Ste Honorine
Research Site
Contes
Research Site
Conty
Research Site
Corbehem
Research Site
Corbeil-Essonnes
Research Site
Corbie
Research Site
Corcieux
Research Site
Cordes-sur-Ciel
Research Site
Coudekerque-Branche
Research Site
Coudes
Research Site
Courbevoie
Research Site
Courçon
Research Site
Courcy
Research Site
Courpière
Research Site
Coursan
Research Site
Courseulles-sur-Mer
Research Site
Courthézon
Research Site
Cousolre
Research Site
Coussac-Bonneval
Research Site
Coutances
Research Site
Coutouvre
Research Site
Coye-la-Forêt
Research Site
Cravanche
Research Site
Crécy-la-Chapelle
Research Site
Creil
Research Site
Créteil
Research Site
Creysse
Research Site
Croissy-sur-Seine
Research Site
Croix
Research Site
Crolles
Research Site
Crosne
Research Site
Cuers
Research Site
Cugand
Research Site
Cuise-la-Motte
Research Site
Dambach-la-Ville
Research Site
Daoulas
Research Site
Daux
Research Site
Décines-Charpieu
Research Site
Dieppe
Research Site
Dieuze
Research Site
Digne-les-Bains
Research Site
Dinard
Research Site
Dissay
Research Site
Dole
Research Site
Dompierre-sur-Mer
Research Site
Donges
Research Site
Dossenheim-sur-Zinsel
Research Site
Dugny-sur-Meuse
Research Site
Dunières

Other trials in France

About this study

Official title: Evaluation of the Control Level (GINA) of Asthmatic Patients Consulting Their General Practitioner for a Seasonal Increase of Respiratory Symptoms (High and / or Low), Whether an Inhaled Corticotherapy is Taken or Not

Conditions: Asthma, Respiratory Symptoms
Keywords: Asthma seasonal respiratory symptoms, Asthmatic patients with increase of respiratory symptoms
Medical subject headings: Asthma, Signs and Symptoms, Respiratory

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00882128
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.

Evaluate the control level of Asthma of asthmatic patients consulting their GP for a seasonal increase of respiratory symptoms (high/low) with an inhaled corticotherapy or not.
Measured: One shot (patients will only have one visit to attend - this visit will take place between May 09 and September 09)

Timeline

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

May 2009Oct 2009

First posted16 Apr 2009 (estimated)
Study startMay 2009
Study completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AsthmaStudies 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: 3,300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00882128
Sponsor's protocol ID: NIS-RFR-DUM-2008/2
Acronym: SAISON
Status last verified: Nov 2009
First submitted: 15 Apr 2009
Last updated: 17 Nov 2009
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

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Control Level (GINA) of Asthmatic Patients Consulting Their General Practitioner for a Seasonal Increase of Respiratory Symptoms (High and / or Low), Whether an Inhaled Corticotherapy is Taken or Not
ClinicalTrials.gov ID: NCT00882128
Acronym / sponsor ID: SAISON / NIS-RFR-DUM-2008/2
Conditions: Asthma, Respiratory Symptoms
Keywords: Asthma seasonal respiratory symptoms, Asthmatic patients with increase of respiratory symptoms
Study type: Observational
Recruitment status: Completed
Enrolment: 3,300 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2009
Study completion: Oct 2009 (actual)
First posted: 16 Apr 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.

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: The first 3 consecutive adult and asthmatic patients consulting their general practitioner for a seasonal increase of respiratory symptoms (high and / or low) and treated with PRN fast acting bronchodilatator alone or associated with inhaled IGCS, excluding all other treatments for asthma.

Key inclusion criteria (1 listed)

Asthmatic adults consulting for a seasonal increase of respiratory symptoms (high/low) and treated with PRN fast acting bronchodilator alone or associated with inhaled IGCS, excluding all other treatments for asthma.

Key exclusion criteria (0 listed)

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

Evaluate the control level of Asthma of asthmatic patients consulting their GP for a seasonal increase of respiratory symptoms (high/low) with an inhaled corticotherapy or not.
Time frame: One shot (patients will only have one visit to attend - this visit will take place between May 09 and September 09)

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 17 Nov 2009.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

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 Castaigne Castaigne study director

AstraZeneca

1,051 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma and Respiratory Symptoms, run by AstraZeneca at 1,051 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 1 inclusion and 0 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 17 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1,051 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?

Evaluate the control level of Asthma of asthmatic patients consulting their GP for a seasonal increase of respiratory symptoms (high/low) with an inhaled corticotherapy or not. (time frame: One shot (patients will only have one visit to attend - this visit will take place between May 09 and September 09)). 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 NCT00882128.

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 17 Nov 2009.