Asthma Control LevelNCT00900861

Asthma Control and Clinical Practice in Hungary 2009

An observational study of Asthma Control Level, run by AstraZeneca at 75 sites in Hungary.

Completed

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

Trial summary

A prospective study led amongst pulmonologists. Patients asthma control level will be evaluated based on GINA guideline criteria. HRQoL measured by Visual analogue scale. Clinical practice: non controlled patients therapy assessed. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma Control Level
How many people: 3,000 participants
Where: 75 sitesHungary
Study dates: Apr 2009to Nov 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: Pulmonology outpatient clinics

Who may be able to join

Asthma patients treated with ICS or bronchodilators

Who cannot join

COPD
pulmonary cancer
pulmonary tuberculosis

Trial locations and contacts

75 sites in 1 country.

City, postcode or hospital

75 sites in 1 country

Hungary75 sites

Research Site
Aszód
Research Site
Bácsalmás
Research Site
Baja
Research Site
Baktalórántháza
Research Site
Balassagyarmat
Research Site
Békés
Research Site
Békéscsaba
Research Site
Berettyóújfalu
Research Site
Bonyhád
Research Site
Cegléd
Research Site
Celldömölk
Research Site
Csorna
Research Site
Dabas
Research Site
Debrecen
Research Site
Dombóvár
Research Site
Dunaharaszti
Research Site
Dunaújváros
Research Site
Dunavecse
Research Site
Edelény
Research Site
Eger
Research Site
Encs
Research Site
Érd
Research Site
Esztergom
Research Site
Gávavencsellő
Research Site
Gödöllő
Research Site
Győr
Research Site
Győrújbarát
Research Site
Gyungyos
Research Site
Hajdúnánás
Research Site
Hatvan
Research Site
Ikrény
Research Site
Jászberény
Research Site
Kaposvár
Research Site
Kapuvár
Research Site
Kazincbarcika
Research Site
Keszthely
Research Site
Kisbér
Research Site
Kiskőrös
Research Site
Kiskunhalas
Research Site
Kistelek
Research Site
Kisvárda
Research Site
Mátészalka
Research Site
Mezőkövesd
Research Site
Miskolc
Research Site
Monor
Research Site
Mór
Research Site
Mosonmagyaróvár
Research Site
Nagyatád
Research Site
Nagykőrös
Research Site
Nyírbátor
Research Site
Nyíregyháza
Research Site
Orosháza
Research Site
Ózd
Research Site
Pápa
Research Site
Pásztó
Research Site
Pécs
Research Site
Salgótarján
Research Site
Sárbogárd
Research Site
Sárvár
Research Site
Siófok
Research Site
Szarvas
Research Site
Százhalombatta
Research Site
Szécsény
Research Site
Szeged
Research Site
Székesfehérvár
Research Site
Szentendre
Research Site
Szerencs
Research Site
Szolnok
Research Site
Tapolca
Research Site
Tata
Research Site
Tiszalök
Research Site
Tiszaújváros
Research Site
Törökbálint
Research Site
Vác
Research Site
Vásárosnamény

Other trials in Hungary

About this study

Conditions: Asthma Control Level
Keywords: asthma control level, visual analogue scale

What participants receive

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

Study groups in NCT00900861
Study group	Role	What they receive
1		Asthmatic patients above 18 y, treated with ICS or bronchodilators

What is being measured

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

Asthma control level
Measured: 3 times

Secondary outcomes (2)

Visual Analogue Scale
Measured: 3 times
Routine Therapeutical habits in control maintenance
Measured: 3 times

Timeline

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

Apr 2009Nov 2009

First posted13 May 2009 (estimated)
Study startApr 2009
Study completionNov 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Asthma Control LevelStudies 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: Prospective
Enrolment: 3,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00900861
Sponsor's protocol ID: NIS-RHU-DUM-2009/1
Status last verified: Dec 2009
First submitted: 12 May 2009
Last updated: 4 Dec 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

Recruiting
This Study Aims to Compare Asthma Control in Children Monitored With FeNO Against a Historical Cohort Without FeNO. Secondary Objectives Include Evaluating Associations Between FeNO Levels, ACT/C-ACT Scores, Eosinophil Counts, FEV1%, ICS Adherence, and Exacerbation Frequency.
Asthma Childhood
RecruitingPhase 4
45th Multicenter Airway Research Collaboration
Asthma Acute, Asthma Exacerbation
RecruitingObservational study
Remission in Adults With Mild-to-moderate Asthma in Thailand
Asthma, Mild-to-moderate Asthma
RecruitingObservational study
Remission in Adults With Severe Asthma in Thailand
Severe Asthma, Asthma Control Level
Not yet recruiting
Effects of Buteyko Breathing Exercise in Children With Uncontrolled Asthma
Breathing Techniques, Asthma Control Level

All Asthma Control Level trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Asthma Control and Clinical Practice in Hungary 2009
ClinicalTrials.gov ID: NCT00900861
Acronym / sponsor ID: NIS-RHU-DUM-2009/1
Conditions: Asthma Control Level
Keywords: asthma control level, visual analogue scale
Study type: Observational
Recruitment status: Completed
Enrolment: 3,000 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Apr 2009
Study completion: Nov 2009 (actual)
First posted: 13 May 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: Prospective
Number of arms: 1

Arm	Type	Receives
1	–	–Asthmatic patients above 18 y, treated with ICS or bronchodilators

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Pulmonology outpatient clinics

Key inclusion criteria (1 listed)

Asthma patients treated with ICS or bronchodilators

Key exclusion criteria (3 listed)

COPD
pulmonary cancer
pulmonary tuberculosis

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

Asthma control level
Time frame: 3 times

2 secondary outcomes

Visual Analogue Scale
Time frame: 3 times
Routine Therapeutical habits in control maintenance
Time frame: 3 times

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 4 Dec 2009.

Related trials for Asthma Control Level

Recruiting
This Study Aims to Compare Asthma Control in Children Monitored With FeNO Against a Historical Cohort Without FeNO. Secondary Objectives Include Evaluating Associations Between FeNO Levels, ACT/C-ACT Scores, Eosinophil Counts, FEV1%, ICS Adherence, and Exacerbation Frequency.
Asthma Childhood
RecruitingPhase 4
45th Multicenter Airway Research Collaboration
Asthma Acute, Asthma Exacerbation
RecruitingObservational study
Remission in Adults With Mild-to-moderate Asthma in Thailand
Asthma, Mild-to-moderate Asthma
RecruitingObservational study
Remission in Adults With Severe Asthma in Thailand
Severe Asthma, Asthma Control Level
Not yet recruiting
Effects of Buteyko Breathing Exercise in Children With Uncontrolled Asthma
Breathing Techniques, Asthma Control Level

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.

Zoltan Bartfai, MD PhD principal investigator

Semmelweis University Budapest Pulmonology Clinic

Lilla Szabo study chair

AstraZeneca Hungary

Eva Gulyas study director

AstraZeneca Hungary

75 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 Control Level, run by AstraZeneca at 75 sites in Hungary.

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 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 4 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 sites in Hungary. 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?

Asthma control level (time frame: 3 times). 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 NCT00900861.

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 4 Dec 2009.