Clinical trial NCT00242411: MONO: Symbicort® Single Inhaler Therapy and Conventional Best Standard Treatment for the Treatment of Persistent Asthma in Adolescents and Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-20
Enrollment: 1900
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of asthma \>= 3 months
* Prescribed daily use of glucocorticosteroids for at least 3 months prior to Visit 1

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Time to first severe asthma exacerbation
Secondary outcomes:
measure: Number of asthma exacerbations
measure: Mean use of as-needed medication
measure: Prescribed asthma medication
measure: Asthma Control Questionnaire
measure: Safety: serious adverse events and discontinuations due to adverse events
measure: All variables assessed over the 6 month treatment period
Other outcomes:
Locations:
city: Aabenraa
country: Denmark
facility: Research Site
city: Aalborg
country: Denmark
facility: Research Site
city: Albertslund
country: Denmark
facility: Research Site
city: Allingåbro
country: Denmark
facility: Research Site
city: Bagsværd
country: Denmark
facility: Research Site
city: Ballerup
country: Denmark
facility: Research Site
city: Billund
country: Denmark
facility: Research Site
city: Birkerød
country: Denmark
facility: Research Site
city: Brønderslev
country: Denmark
facility: Research Site
city: Brønshøj
country: Denmark
facility: Research Site
city: Ejby
country: Denmark
facility: Research Site
city: Fredericia
country: Denmark
facility: Research Site
city: Frederiksberg C
country: Denmark
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city: Frederiksberg
country: Denmark
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city: Frederikshavn
country: Denmark
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city: Frederikssund
country: Denmark
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city: Fåborg
country: Denmark
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city: Glesborg
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city: Glumsø
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city: Greve
country: Denmark
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city: Hellerup
country: Denmark
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city: Helsinge
country: Denmark
facility: Research Site
city: Herning
country: Denmark
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city: Hillerød
country: Denmark
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country: Denmark
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country: Denmark
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country: Denmark
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country: Denmark
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city: Hvidovre
country: Denmark
facility: Research Site
city: Hårlev
country: Denmark
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city: Ikast
country: Denmark
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city: Jægerspris
country: Denmark
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city: Karlslunde
country: Denmark
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country: Denmark
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city: Kjellerup
country: Denmark
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city: Korsør
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country: Denmark
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city: København K
country: Denmark
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city: København S
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city: København Ø
country: Denmark
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country: Denmark
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city: Lystrup
country: Denmark
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country: Denmark
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city: Ålestrup
country: Denmark
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city: Århus C
country: Denmark
facility: Research Site
city: Ølstykke
country: Denmark
facility: Research Site
city: Anjalankoski
country: Finland
facility: Research Site
city: Espoo
country: Finland
facility: Research Site
city: Hammaslahti
country: Finland
facility: Research Site
city: Harjavalta
country: Finland
facility: Research Site
city: Heinola
country: Finland
facility: Research Site
city: Helsingin kaup
country: Finland
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Joensuu
country: Finland
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city: Joutseno
country: Finland
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city: Jyväskylä
country: Finland
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city: Kajaani
country: Finland
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city: Kinkomaa
country: Finland
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city: Kotka
country: Finland
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city: Kouvola
country: Finland
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city: Kuusamo
country: Finland
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city: Lahti
country: Finland
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city: Lappeenranta
country: Finland
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city: Lapua
country: Finland
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country: Finland
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city: Lohja
country: Finland
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country: Finland
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country: Finland
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country: Finland
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city: Nokia
country: Finland
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country: Finland
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country: Finland
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country: Finland
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country: Finland
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country: Finland
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country: Finland
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country: Finland
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country: Finland
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country: Finland
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country: Finland
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city: Aksdal
country: Norway
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city: Arendal
country: Norway
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city: Asker
country: Norway
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city: Bergen
country: Norway
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city: Bodø
country: Norway
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city: Drammen
country: Norway
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city: Fevik
country: Norway
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city: Fjerdingby
country: Norway
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city: Flatåsen
country: Norway
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city: Fredrikstad
country: Norway
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city: Fyllingsdalen
country: Norway
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city: Hafrsfjord
country: Norway
facility: Research Site
city: Harstad
country: Norway
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city: Haugesund
country: Norway
facility: Research Site
city: Hosle
country: Norway
facility: Research Site
city: Høvik
country: Norway
facility: Research Site
city: Karmsund
country: Norway
facility: Research Site
city: Kristiansand
country: Norway
facility: Research Site
city: Lena
country: Norway
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city: Lierskogen
country: Norway
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city: Lier
country: Norway
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city: Lillestrøm
country: Norway
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city: Lysaker
country: Norway
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city: Lørenskog
country: Norway
facility: Research Site
city: Løvenstad
country: Norway
facility: Research Site
city: Molde
country: Norway
facility: Research Site
city: Nesbru
country: Norway
facility: Research Site
city: Nesttun
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Paradis
country: Norway
facility: Research Site
city: ROA
country: Norway
facility: Research Site
city: Rykkinn
country: Norway
facility: Research Site
city: Rådal
country: Norway
facility: Research Site
city: Sandvika
country: Norway
facility: Research Site
city: Skedsmokorset
country: Norway
facility: Research Site
city: Skien
country: Norway
facility: Research Site
city: SKI
country: Norway
facility: Research Site
city: Slependen
country: Norway
facility: Research Site
city: Spikkestad
country: Norway
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city: Steinkjer
country: Norway
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city: Straume
country: Norway
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city: Strømmen
country: Norway
facility: Research Site
city: Svelvik
country: Norway
facility: Research Site
city: Søgne
country: Norway
facility: Research Site
city: Sørumsand
country: Norway
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city: Tolvsrød
country: Norway
facility: Research Site
city: Trollåsen
country: Norway
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city: Tromsø
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research Site
city: Ulset
country: Norway
facility: Research Site
city: Årnes
country: Norway
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Symbicort Medical Science Director, MD
role: STUDY_DIRECTOR
References: