Asthma Clinical Trial
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
| Verified date | January 2011 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: Danish Medicines Agency |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1900 |
| Est. completion date | October 2006 |
| Est. primary completion date | October 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Research Site | Aabenraa | |
| Denmark | Research Site | Aalborg | |
| Denmark | Research Site | Åbenrå | |
| Denmark | Research Site | Ålbæk | |
| Denmark | Research Site | Albertslund | |
| Denmark | Research Site | Ålborg | |
| Denmark | Research Site | Ålestrup | |
| Denmark | Research Site | Allingåbro | |
| Denmark | Research Site | Århus C | |
| Denmark | Research Site | Bagsværd | |
| Denmark | Research Site | Ballerup | |
| Denmark | Research Site | Billund | |
| Denmark | Research Site | Birkerød | |
| Denmark | Research Site | Brønderslev | |
| Denmark | Research Site | Brønshøj | |
| Denmark | Research Site | Ejby | |
| Denmark | Research Site | Fåborg | |
| Denmark | Research Site | Fredericia | |
| Denmark | Research Site | Frederiksberg | |
| Denmark | Research Site | Frederiksberg C | |
| Denmark | Research Site | Frederikshavn | |
| Denmark | Research Site | Frederikssund | |
| Denmark | Research Site | Glesborg | |
| Denmark | Research Site | Glumsø | |
| Denmark | Research Site | Greve | |
| Denmark | Research Site | Hårlev | |
| Denmark | Research Site | Hellerup | |
| Denmark | Research Site | Helsinge | |
| Denmark | Research Site | Herning | |
| Denmark | Research Site | Hillerød | |
| Denmark | Research Site | Holbæk | |
| Denmark | Research Site | Hornbæk | |
| Denmark | Research Site | Horsens | |
| Denmark | Research Site | Humlebæk | |
| Denmark | Research Site | Hvidovre | |
| Denmark | Research Site | Ikast | |
| Denmark | Research Site | Jægerspris | |
| Denmark | Research Site | Karlslunde | |
| Denmark | Research Site | Kastrup | |
| Denmark | Research Site | Kjellerup | |
| Denmark | Research Site | Klarup | |
| Denmark | Research Site | København K | |
| Denmark | Research Site | København Ø | |
| Denmark | Research Site | København S | |
| Denmark | Research Site | Kolding | |
| Denmark | Research Site | Kolind | |
| Denmark | Research Site | Korsør | |
| Denmark | Research Site | Kværndrup | |
| Denmark | Research Site | Lynge | |
| Denmark | Research Site | Lystrup | |
| Denmark | Research Site | Nærum | |
| Denmark | Research Site | Næstved | |
| Denmark | Research Site | Nakskov | |
| Denmark | Research Site | Nibe | |
| Denmark | Research Site | Nørre-Alslev | |
| Denmark | Research Site | Nørresundby | |
| Denmark | Research Site | Nyborg | |
| Denmark | Research Site | Nykøbing F. | |
| Denmark | Research Site | Odense C | |
| Denmark | Research Site | Odense NV | |
| Denmark | Research Site | Oksbøl | |
| Denmark | Research Site | Ølstykke | |
| Denmark | Research Site | Randers | |
| Denmark | Research Site | Redsted M. | |
| Denmark | Research Site | Ringsted | |
| Denmark | Research Site | Risskov | |
| Denmark | Research Site | Rødovre | |
| Denmark | Research Site | Roskilde | |
| Denmark | Research Site | Rudkøbing | |
| Denmark | Research Site | Rungsted Kyst | |
| Denmark | Research Site | Sæby | |
| Denmark | Research Site | Saltum | |
| Denmark | Research Site | Skibby | |
| Denmark | Research Site | Slagelse | |
| Denmark | Research Site | Sønderborg | |
| Denmark | Research Site | Søndersø | |
| Denmark | Research Site | Stensved | |
| Denmark | Research Site | Struer | |
| Denmark | Research Site | Sulsted | |
| Denmark | Research Site | Svendborg | |
| Denmark | Research Site | Tåstrup | |
| Denmark | Research Site | Thorsø | |
| Denmark | Research Site | Tølløse | |
| Denmark | Research Site | Tønder | |
| Denmark | Research Site | Varde | |
| Denmark | Research Site | Viborg | |
| Denmark | Research Site | Viby J | |
| Denmark | Research Site | Vojens | |
| Finland | Research Site | Anjalankoski | |
| Finland | Research Site | Espoo | |
| Finland | Research Site | Hammaslahti | |
| Finland | Research Site | Harjavalta | |
| Finland | Research Site | Heinola | |
| Finland | Research Site | Helsingin kaup | |
| Finland | Research Site | Helsinki | |
| Finland | Research Site | Joensuu | |
| Finland | Research Site | Joutseno | |
| Finland | Research Site | Jyväskylä | |
| Finland | Research Site | Kajaani | |
| Finland | Research Site | Kinkomaa | |
| Finland | Research Site | Kotka | |
| Finland | Research Site | Kouvola | |
| Finland | Research Site | Kuusamo | |
| Finland | Research Site | Lahti | |
| Finland | Research Site | Lappeenranta | |
| Finland | Research Site | Lapua | |
| Finland | Research Site | Lieto | |
| Finland | Research Site | Lohja | |
| Finland | Research Site | Mäntsälä | |
| Finland | Research Site | Mikkeli | |
| Finland | Research Site | Muhos | |
| Finland | Research Site | Nokia | |
| Finland | Research Site | Oulu | |
| Finland | Research Site | Parkano | |
| Finland | Research Site | Pattijoki | |
| Finland | Research Site | Pietarsaari | |
| Finland | Research Site | Polvijärvi | |
| Finland | Research Site | Pori | |
| Finland | Research Site | Porvoo | |
| Finland | Research Site | Ristiina | |
| Finland | Research Site | Rovaniemi | |
| Finland | Research Site | Savonlinna | |
| Finland | Research Site | Tampere | |
| Finland | Research Site | Tornio | |
| Finland | Research Site | Turku | |
| Finland | Research Site | Vantaa | |
| Finland | Research Site | Varkaus | |
| Finland | Research Site | Vimpeli | |
| Finland | Research Site | Ylitornio | |
| Finland | Research Site | Ylöjärvi | |
| Norway | 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 | Drammen | |
| Norway | Research Site | Fevik | |
| Norway | Research Site | Fjerdingby | |
| Norway | Research Site | Flatåsen | |
| Norway | Research Site | Fredrikstad | |
| Norway | Research Site | Fyllingsdalen | |
| Norway | Research Site | Hafrsfjord | |
| 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 | 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 | 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 | Ulset |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Denmark, Finland, Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to first severe asthma exacerbation | |||
| Secondary | Number of asthma exacerbations | |||
| Secondary | Mean use of as-needed medication | |||
| Secondary | Prescribed asthma medication | |||
| Secondary | Asthma Control Questionnaire | |||
| Secondary | Safety: serious adverse events and discontinuations due to adverse events | |||
| Secondary | All variables assessed over the 6 month treatment period |
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