AsthmaUFONCT01327001

Utilization of Fixed Combination (Budesonide/Formoterol and Salmeterol/Fluticasone and Beclomethasone/Formoterol) in Treatment of Asthma Patients

An observational study of Asthma, run by AstraZeneca at 100 sites in Czechia.

Completed

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

Trial summary

Moderate and severe asthma bronchiale is treated by fixed combination (budesonide/formoterol or salmeterol/fluticasone) in the Czech Republic. There is a hypothesis that doctors should prescribe to each patients per year: six units of fixed combination budesonide/formoterol, or seven units of fixed combination… Read more about this study

Who is it for?: Ages 6 years and older
Conditions the study is for: Asthma
How many people: 2,815 participants
Where: 100 sitesCzechia
Study dates: Apr 2011to Jun 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 6 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Primary care clinic (specialists in allergology and pulmology)

Who may be able to join

Male or female aged 6 years or over
Asthma bronchiale, classification of severity - moderate or severe persistent
Documented fixed combination (budesonide/formoterol or salmeterol/fluticasone) therapy for at least 18 months

Who cannot join

None listed.

Trial locations and contacts

100 sites in 1 country.

City, postcode or hospital

100 sites in 1 country

Czechia100 sites

Research Site
Benešov
Research Site
Beroun
Research Site
Bílovec
Research Site
Blansko
Research Site
Blovice
Research Site
Bohumín
Research Site
Brandys N/L
Research Site
Brno
Research Site
Čáslav
Research Site
Česká Lípa
Research Site
České Budějovice
Research Site
Český Krumlov
Research Site
Český Těšín
Research Site
Cheb
Research Site
Chomutov
Research Site
Chotěboř
Research Site
Chrudim
Research Site
Děčín
Research Site
Domažlice
Research Site
Fifejdy Ostrava
Research Site
Frýdek-Místek
Research Site
Fryštát
Research Site
Havířov
Research Site
Havlíčkův Brod
Research Site
Holice
Research Site
Horažďovice
Research Site
Hořovice
Research Site
Hradec Králové
Research Site
Hranice
Research Site
Jablonec N/N
Research Site
Jilemnice
Research Site
Jindřichův Hradec
Research Site
Kadaň
Research Site
Karlovy Vary
Research Site
Kladno
Research Site
Klatovy
Research Site
Kolín
Research Site
Kralupy N/V
Research Site
Krnov
Research Site
Kroměříž
Research Site
Kutná Hora
Research Site
Liberec
Research Site
Litoměřice
Research Site
Litomyšl
Research Site
Litvnov
Research Site
Lochovice
Research Site
Lovosice
Research Site
MarianskeLazne
Research Site
Mělník
Research Site
Mladá Boleslav
Research Site
Mnichovo Hradiště
Research Site
Most
Research Site
Náchod
Research Site
Neratovice
Research Site
Nové Město na Moravě
Research Site
Nový Jičín
Research Site
Olomouc
Research Site
Opava
Research Site
Orlová
Research Site
Ostrava
Research Site
Ostrava - Hrabuvka
Research Site
Pardubice
Research Site
Pelhřimov
Research Site
Pilsen
Research Site
Písek
Research Site
Poděbrady
Research Site
Prachatice
Research Site
Prague
Research Site
Přerov
Research Site
Příbor
Research Site
Příbram
Research Site
Prostějov
Research Site
Prostejov - Karlov
Research Site
Rakovník
Research Site
Roudnice N/L
Research Site
Rožnov pod Radhoštěm
Research Site
Rychnov nad Kněžnou
Research Site
Slaný
Research Site
Sokolov
Research Site
Stod
Research Site
Strakonice
Research Site
Šumperk
Research Site
Svitavy
Research Site
Tábor
Research Site
Tachov
Research Site
Teplice
Research Site
Třebíč
Research Site
Třemošná
Research Site
Trutnov
Research Site
Týn nad Vltavou
Research Site
Ústí nad Labem
Research Site
Valašské Meziříčí
Research Site
Vsetín
Research Site
Vyškov
Research Site
Žamberk
Research Site
Žatec
Research Site
Zdar
Research Site
Železný Brod
Research Site
Zlín
Research Site
Znojmo

Other trials in Czechia

About this study

Official title: Utilization of Fixed Combination (Budesonide/Formoterol and Salmeterol/Fluticasone and Beclomethasone/Formoterol) in Treatment of Asthma Patients in Real Life Condition in Czech Republic (UFO)

Moderate and severe asthma bronchiale is treated by fixed combination (budesonide/formoterol or salmeterol/fluticasone) in the Czech Republic.

There is a hypothesis that doctors should prescribe to each patients per year: six units of fixed combination budesonide/formoterol, or seven units of fixed combination budesonide/formoterol in approach SMART, or twelve units of fixed combination salmeterol/fluticasone. With regard to current prices the treatment by fixed combination budesonide/formoterol should cost less.

The investigators do not have any data about real life utilization of fixed combination in asthma treatment in Czech Republic The investigators propose to conduct a non-interventional multicentric retrospective epidemiological study looking into the patients records kept by specialist - allergists and pulmologists.

Retrospective data for eligible patients will be reviewed by participating investigators, physicians taking care of their patients, and recorded in the electronic CRF. Only patients who have been treated for asthma bronchiale (classification of severity - moderate or severe persistent asthma) with fixed combination for at least one year could be included into the study. There are no scheduled visits for any patient participating in the study.

Conditions: Asthma
Keywords: Asthma bronchiale, fixed combination
Medical subject headings: Asthma

What is being measured

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

Number of packs of fixed combination prescribed to patients with asthma bronchiale in one year
Measured: 1 year

Secondary outcomes (2)

Asthma severity in patients treated with fixed combination
Measured: 1 year
Strength/dose of prescribed fixed combination
Measured: 1 year

Timeline

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

Apr 2011Jun 2011

First posted31 Mar 2011 (estimated)
Study startApr 2011
Study completionJun 2011

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: Case only
Time perspective: Retrospective
Enrolment: 2,815 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01327001
Sponsor's protocol ID: NIS-RCZ-SYM-2010/1
Acronym: UFO
Status last verified: Jul 2011
First submitted: 28 Mar 2011
Last updated: 25 Jul 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

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Asthma
RecruitingPhase 1
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RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Utilization of Fixed Combination (Budesonide/Formoterol and Salmeterol/Fluticasone and Beclomethasone/Formoterol) in Treatment of Asthma Patients in Real Life Condition in Czech Republic (UFO)
ClinicalTrials.gov ID: NCT01327001
Acronym / sponsor ID: UFO / NIS-RCZ-SYM-2010/1
Conditions: Asthma
Keywords: Asthma bronchiale, fixed combination
Study type: Observational
Recruitment status: Completed
Enrolment: 2,815 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Apr 2011
Study completion: Jun 2011 (actual)
First posted: 31 Mar 2011 (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.

Moderate and severe asthma bronchiale is treated by fixed combination (budesonide/formoterol or salmeterol/fluticasone) in the Czech Republic.

Study design

Observational model: Case only
Time perspective: Retrospective

Who may qualify

Ages: 6 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Primary care clinic (specialists in allergology and pulmology)

Key inclusion criteria (3 listed)

Male or female aged 6 years or over
Asthma bronchiale, classification of severity - moderate or severe persistent
Documented fixed combination (budesonide/formoterol or salmeterol/fluticasone) therapy for at least 18 months

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

Number of packs of fixed combination prescribed to patients with asthma bronchiale in one year
Time frame: 1 year

2 secondary outcomes

Asthma severity in patients treated with fixed combination
Time frame: 1 year
Strength/dose of prescribed fixed combination
Time frame: 1 year

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 25 Jul 2011.

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.

Viktor Kasak, MD principal investigator

LERYMED spol. s.r.o.

100 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, run by AstraZeneca at 100 sites in Czechia.

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 3 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 25 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in Czechia. 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?

Number of packs of fixed combination prescribed to patients with asthma bronchiale in one year (time frame: 1 year). 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 NCT01327001.

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 25 Jul 2011.