AsthmaPhase 4NCT00242411
MONO: Symbicort® Single Inhaler Therapy and Conventional Best Standard Treatment for the Treatment of Persistent Asthma in Adolescents and Adults
A Phase 4 study testing Budesonide/Formoterol Turbuhaler and Conventional Best Asthma Therapy in people with Asthma, run by AstraZeneca at 179 sites in 3 countries.
Trial summary
The purpose of the study is to compare the efficacy of a flexible dose of Symbicort (budesonide/formoterol) with conventional stepwise best standard treatment in patients with persistent asthma. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide/Formoterol Turbuhaler and Conventional Best Asthma Therapy
- How many people
- 1,900 participants
- Where
- 179 sitesin 3 countries
- Study dates
- Sep 2004to Oct 2006
- Phase
- Phase 4
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of asthma >= 3 months
- Prescribed daily use of glucocorticosteroids for at least 3 months prior to Visit 1
Who cannot join
- Smoking history > 10 pack-years
- Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion
- Any significant disease or disorder that may jeopardize the safety of the patient.
- Additional inclusion and exclusion criteria will be evaluated by the investigator.
Trial locations and contacts
179 sites in 3 countries.
179 sites in 3 countries
Denmark86 sites
Research Site
Aabenraa
Research Site
Aalborg
Research Site
Ålbæk
Research Site
Albertslund
Research Site
Ålestrup
Research Site
Allingåbro
Research Site
Århus C
Research Site
Bagsværd
Research Site
Ballerup Municipality
Research Site
Billund
Research Site
Birkerød
Research Site
Brønderslev
Research Site
Brønshøj
Research Site
Ejby
Research Site
Fåborg
Research Site
Fredericia
Research Site
Frederiksberg
Research Site
Frederiksberg C
Research Site
Frederikshavn
Research Site
Frederikssund
Research Site
Glesborg
Research Site
Glumsø
Research Site
Greve
Research Site
Hårlev
Research Site
Hellerup
Research Site
Helsinge
Research Site
Herning
Research Site
Hillerød
Research Site
Holbæk
Research Site
Hornbæk
Research Site
Horsens
Research Site
Humlebæk
Research Site
Hvidovre
Research Site
Ikast
Research Site
Jægerspris
Research Site
Karlslunde
Research Site
Kåstrup
Research Site
Kjellerup
Research Site
Klarup
Research Site
København K
Research Site
København Ø
Research Site
København S
Research Site
Kolding
Research Site
Kolind
Research Site
Korsør
Research Site
Kværndrup
Research Site
Lynge
Research Site
Lystrup
Research Site
Nærum
Research Site
Næstved
Research Site
Nakskov
Research Site
Nibe
Research Site
Nørre Alslev
Research Site
Nørresundby
Research Site
Nyborg
Research Site
Nykøbing Falster
Research Site
Odense C
Research Site
Odense NV
Research Site
Oksbøl
Research Site
Ølstykke
Research Site
Randers
Research Site
Redsted
Research Site
Ringsted
Research Site
Risskov
Research Site
Rødovre Municipality
Research Site
Roskilde
Research Site
Rudkøbing
Research Site
Rungsted Kyst
Research Site
Sæby
Research Site
Saltum
Research Site
Skibby
Research Site
Slagelse
Research Site
Sønderborg
Research Site
Søndersø
Research Site
Stensved
Research Site
Struer Municipality
Research Site
Sulsted
Research Site
Svendborg
Research Site
Tåstrup
Research Site
Thorsø
Research Site
Tølløse
Research Site
Tønder
Research Site
Varde
Research Site
Viborg
Research Site
Viby J
Research Site
Vojens
Norway51 sites
Research Site
Aksdal
Research Site
Arendal
Research Site
Årnes
Research Site
Asker
Research Site
Bergen
Research Site
Bodø
Research Site
Drammen
Research Site
Fevik
Research Site
Fjerdingby
Research Site
Flatåsen
Research Site
Fredrikstad
Research Site
Fyllingsdalen
Research Site
Hafrsfjord
Research Site
Harstad
Research Site
Haugesund
Research Site
Hosle
Research Site
Høvik
Research Site
Karmsund
Research Site
Kristiansand
Research Site
Lena
Research Site
Lier
Research Site
Lierskogen
Research Site
Lillestrøm
Research Site
Lørenskog
Research Site
Løvenstad
Research Site
Lysaker
Research Site
Molde
Research Site
Nesbru
Research Site
Nesttun
Research Site
Oslo
Research Site
Paradis
Research Site
Rådal
Research Site
Røa
Research Site
Rykkin
Research Site
Sandvika
Research Site
Skedsmokorset
Research Site
Ski
Research Site
Skien
Research Site
Slependen
Research Site
Søgne
Research Site
Sørumsand
Research Site
Spikkestad
Research Site
Steinkjer
Research Site
Straume
Research Site
Strømmen
Research Site
Svelvik
Research Site
Tolvsrød
Research Site
Trollåsen
Research Site
Tromsø
Research Site
Trondheim
Research Site
Ulset
Finland42 sites
Research Site
Anjalankoski
Research Site
Espoo
Research Site
Hammaslahti
Research Site
Harjavalta
Research Site
Heinola
Research Site
Helsingin Kaup
Research Site
Helsinki
Research Site
Jakobstad
Research Site
Joensuu
Research Site
Joutseno
Research Site
Jyväskylä
Research Site
Kajaani
Research Site
Kinkomaa
Research Site
Kotka
Research Site
Kouvola
Research Site
Kuusamo
Research Site
Lahti
Research Site
Lappeenranta
Research Site
Lapua
Research Site
Lieto
Research Site
Lohja
Research Site
Mäntsälä
Research Site
Mikkeli
Research Site
Muhos
Research Site
Nokia
Research Site
Oulu
Research Site
Parkano
Research Site
Pattijoki
Research Site
Polvijärvi
Research Site
Pori
Research Site
Porvoo
Research Site
Ristiina
Research Site
Rovaniemi
Research Site
Savonlinna
Research Site
Tampere
Research Site
Tornio
Research Site
Turku
Research Site
Vantaa
Research Site
Varkaus
Research Site
Vimpeli
Research Site
Ylitornio
Research Site
Ylöjärvi
About this study
Official title: A Comparison of the Efficacy of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5 mg 1 Inhalation b.i.d. Plus As-needed) and Conventional Best Standard Treatment for the Treatment of Persistent Asthma in Adolescents and Adults. A Randomized, Open, Parallel-group, Multicentre 26-weeks Study
The purpose of the study is to compare the efficacy of a flexible dose of Symbicort (budesonide/formoterol) with conventional stepwise best standard treatment in patients with persistent asthma.
- Conditions
- Asthma
- Being tested
- Budesonide/Formoterol Turbuhaler, Conventional Best Asthma Therapy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide/Formoterol TurbuhalerDrug
Conventional Best Asthma TherapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first severe asthma exacerbation
Secondary outcomes (6)
Number of asthma exacerbations
Mean use of as-needed medication
Prescribed asthma medication
Asthma Control Questionnaire
Safety: serious adverse events and discontinuations due to adverse events
All variables assessed over the 6 month treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2005 (estimated)
- Study startSep 2004
- Primary completionOct 2006
- Study completionOct 2006
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,900 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Symbicort Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242411
- Sponsor's protocol ID
- D5890L00008
- Status last verified
- Jan 2011
- First submitted
- 18 Oct 2005
- Last updated
- 24 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Efficacy of Symbicort® Single Inhaler Therapy (Symbicort Turbuhaler® 160/4.5 mg 1 Inhalation b.i.d. Plus As-needed) and Conventional Best Standard Treatment for the Treatment of Persistent Asthma in Adolescents and Adults. A Randomized, Open, Parallel-group, Multicentre 26-weeks Study
- ClinicalTrials.gov ID
- NCT00242411
- Acronym / sponsor ID
- D5890L00008
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,900 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 20 Oct 2005 (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 the study is to compare the efficacy of a flexible dose of Symbicort (budesonide/formoterol) with conventional stepwise best standard treatment in patients with persistent asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of asthma >= 3 months
- Prescribed daily use of glucocorticosteroids for at least 3 months prior to Visit 1
Key exclusion criteria (4 listed)
- Smoking history > 10 pack-years
- Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion
- Any significant disease or disorder that may jeopardize the safety of the patient.
- Additional inclusion and exclusion criteria will be evaluated by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide/Formoterol Turbuhaler | Drug | – |
| Conventional Best Asthma Therapy | Drug | – |
Primary outcome
Time to first severe asthma exacerbation
6 secondary outcomes
Number of asthma exacerbations
Mean use of as-needed medication
Prescribed asthma medication
Asthma Control Questionnaire
Safety: serious adverse events and discontinuations due to adverse events
All variables assessed over the 6 month treatment period
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 24 Jan 2011.
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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.
AstraZeneca Symbicort Medical Science Director, MD study director
AstraZeneca
179 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Budesonide/Formoterol Turbuhaler and Conventional Best Asthma Therapy in people with Asthma, run by AstraZeneca at 179 sites in 3 countries.
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 4 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 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 179 sites in Denmark, Norway, Finland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to first severe asthma exacerbation. 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 24 Jan 2011.