MONO: Symbicort® Single Inhaler Therapy and Conventional Best Standard Treatment for the Treatment of Persistent Asthma in Adolescents and Adults

Condition(s) targeted: Asthma

Intervention: Budesonide/Formoterol Turbuhaler (Drug); Conventional Best Asthma Therapy (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Symbicort Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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.

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Time to first severe asthma exacerbation

Secondary outcome:

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

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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.

Research Site, København K, Denmark

Research Site, København Ø, Denmark

Research Site, København S, Denmark

Research Site, Rungsted Kyst, Denmark

Research Site, Humlebæk, Denmark

Research Site, Hornbæk, Denmark

Research Site, Helsinge, Denmark

Research Site, Hillerød, Denmark

Research Site, Lynge, Denmark

Research Site, Frederikssund, Denmark

Research Site, Jægerspris, Denmark

Research Site, Ølstykke, Denmark

Research Site, Skibby, Denmark

Research Site, Birkerød, Denmark

Research Site, Brønshøj, Denmark

Research Site, Frederiksberg C, Denmark

Research Site, Frederiksberg, Denmark

Research Site, Rødovre, Denmark

Research Site, Albertslund, Denmark

Research Site, Tåstrup, Denmark

Research Site, Hvidovre, Denmark

Research Site, Ballerup, Denmark

Research Site, Kastrup, Denmark

Research Site, Nærum, Denmark

Research Site, Bagsværd, Denmark

Research Site, Hellerup, Denmark

Research Site, Greve, Denmark

Research Site, Roskilde, Denmark

Research Site, Ringsted, Denmark

Research Site, Glumsø, Denmark

Research Site, Slagelse, Denmark

Research Site, Hårlev, Denmark

Research Site, Næstved, Denmark

Research Site, Stensved, Denmark

Research Site, Nykøbing F., Denmark

Research Site, Nørre-Alslev, Denmark

Research Site, Nakskov, Denmark

Research Site, Holbæk, Denmark

Research Site, Karlslunde, Denmark

Research Site, Tølløse, Denmark

Research Site, Korsør, Denmark

Research Site, Tønder, Denmark

Research Site, Odense C, Denmark

Research Site, Odense NV, Denmark

Research Site, Ejby, Denmark

Research Site, Svendborg, Denmark

Research Site, Nyborg, Denmark

Research Site, Rudkøbing, Denmark

Research Site, Aabenraa, Denmark

Research Site, Sønderborg, Denmark

Research Site, Oksbøl, Denmark

Research Site, Billund, Denmark

Research Site, Varde, Denmark

Research Site, Vojens, Denmark

Research Site, Kværndrup, Denmark

Research Site, Fåborg, Denmark

Research Site, Søndersø, Denmark

Research Site, Åbenrå, Denmark

Research Site, Kolding, Denmark

Research Site, Århus C, Denmark

Research Site, Kolind, Denmark

Research Site, Lystrup, Denmark

Research Site, Viby J, Denmark

Research Site, Glesborg, Denmark

Research Site, Horsens, Denmark

Research Site, Randers, Denmark

Research Site, Allingåbro, Denmark

Research Site, Risskov, Denmark

Research Site, Fredericia, Denmark

Research Site, Herning, Denmark

Research Site, Ikast, Denmark

Research Site, Struer, Denmark

Research Site, Redsted M., Denmark

Research Site, Kjellerup, Denmark

Research Site, Viborg, Denmark

Research Site, Thorsø, Denmark

Research Site, Aalborg, Denmark

Research Site, Klarup, Denmark

Research Site, Sulsted, Denmark

Research Site, Sæby, Denmark

Research Site, Ålbæk, Denmark

Research Site, Nørresundby, Denmark

Research Site, Ålestrup, Denmark

Research Site, Brønderslev, Denmark

Research Site, Frederikshavn, Denmark

Research Site, Saltum, Denmark

Research Site, Ålborg, Denmark

Research Site, Nibe, Denmark

Research Site, Helsinki, Finland

Research Site, Tampere, Finland

Research Site, Oulu, Finland

Research Site, Joutseno, Finland

Research Site, Ylitornio, Finland

Research Site, Vantaa, Finland

Research Site, Lohja, Finland

Research Site, Kotka, Finland

Research Site, Turku, Finland

Research Site, Vantaa, Finland

Research Site, Kajaani, Finland

Research Site, Pietarsaari, Finland

Research Site, Harjavalta, Finland

Research Site, Heinola, Finland

Research Site, Lappeenranta, Finland

Research Site, Joensuu, Finland

Research Site, Rovaniemi, Finland

Research Site, Mikkeli, Finland

Research Site, Varkaus, Finland

Research Site, Kouvola, Finland

Research Site, Kuusamo, Finland

Research Site, Tornio, Finland

Research Site, Lieto, Finland

Research Site, Lahti, Finland

Research Site, Muhos, Finland

Research Site, Kinkomaa, Finland

Research Site, Espoo, Finland

Research Site, Hammaslahti, Finland

Research Site, Jyväskylä, Finland

Research Site, Muhos, Finland

Research Site, Anjalankoski, Finland

Research Site, Espoo, Finland

Research Site, Helsingin kaup, Finland

Research Site, Helsinki, Finland

Research Site, Lahti, Finland

Research Site, Lapua, Finland

Research Site, Mäntsälä, Finland

Research Site, Nokia, Finland

Research Site, Oulu, Finland

Research Site, Parkano, Finland

Research Site, Pattijoki, Finland

Research Site, Polvijärvi, Finland

Research Site, Pori, Finland

Research Site, Porvoo, Finland

Research Site, Porvoo, Finland

Research Site, Ristiina, Finland

Research Site, Savonlinna, Finland

Research Site, Tampere, Finland

Research Site, Vimpeli, Finland

Research Site, Ylitornio, Finland

Research Site, Ylöjärvi, Finland

Research Site, AKSDAL, Norway

Research Site, ARENDAL, Norway

Research Site, ÅRNES, Norway

Research Site, ASKER, Norway

Research Site, BERGEN, Norway

Research Site, BODØ, Norway

Research Site, BODØ, Norway

Research Site, DRAMMEN, Norway

Research Site, DRAMMEN, Norway

Research Site, FEVIK, Norway

Research Site, FJERDINGBY, Norway

Research Site, FLATÅSEN, Norway

Research Site, FREDRIKSTAD, Norway

Research Site, FREDRIKSTAD, Norway

Research Site, FYLLINGSDALEN, Norway

Research Site, HAFRSFJORD, Norway

Research Site, HARSTAD, Norway

Research Site, HARSTAD, Norway

Research Site, HAUGESUND, Norway

Research Site, HOSLE, Norway

Research Site, HØVIK, Norway

Research Site, KARMSUND, Norway

Research Site, KRISTIANSAND, Norway

Research Site, KRISTIANSAND, Norway

Research Site, LENA, Norway

Research Site, LIER, Norway

Research Site, LIERSKOGEN, Norway

Research Site, LILLESTRØM, Norway

Research Site, LØRENSKOG, Norway

Research Site, LØVENSTAD, Norway

Research Site, LYSAKER, Norway

Research Site, MOLDE, Norway

Research Site, NESBRU, Norway

Research Site, NESTTUN, Norway

Research Site, OSLO, Norway

Research Site, OSLO, Norway

Research Site, PARADIS, Norway

Research Site, RÅDAL, Norway

Research Site, ROA, Norway

Research Site, RYKKINN, Norway

Research Site, SANDVIKA, Norway

Research Site, SKEDSMOKORSET, Norway

Research Site, SKI, Norway

Research Site, SKIEN, Norway

Research Site, SLEPENDEN, Norway

Research Site, SØGNE, Norway

Research Site, SØRUMSAND, Norway

Research Site, SPIKKESTAD, Norway

Research Site, STEINKJER, Norway

Research Site, STRAUME, Norway

Research Site, STRØMMEN, Norway

Research Site, SVELVIK, Norway

Research Site, TOLVSRØD, Norway

Research Site, TROLLÅSEN, Norway

Research Site, TROMSØ, Norway

Research Site, TRONDHEIM, Norway

Research Site, TRONDHEIM, Norway

Research Site, ULSET, Norway

Starting date: September 2004
Ending date: October 2006
Last updated: January 11, 2008