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

January 21, 2011 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1900

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aabenraa, Denmark
        • Research Site
      • Aalborg, Denmark
        • Research Site
      • Albertslund, Denmark
        • Research Site
      • Allingåbro, 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
      • Fredericia, Denmark
        • Research Site
      • Frederiksberg, Denmark
        • Research Site
      • Frederiksberg C, Denmark
        • Research Site
      • Frederikshavn, Denmark
        • Research Site
      • Frederikssund, Denmark
        • Research Site
      • Fåborg, Denmark
        • Research Site
      • Glesborg, Denmark
        • Research Site
      • Glumsø, Denmark
        • Research Site
      • Greve, 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
      • Hårlev, 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
      • Kolding, Denmark
        • Research Site
      • Kolind, Denmark
        • Research Site
      • Korsør, Denmark
        • Research Site
      • Kværndrup, Denmark
        • Research Site
      • København K, Denmark
        • Research Site
      • København S, Denmark
        • Research Site
      • København Ø, Denmark
        • Research Site
      • Lynge, Denmark
        • Research Site
      • Lystrup, Denmark
        • Research Site
      • Nakskov, Denmark
        • Research Site
      • Nibe, Denmark
        • Research Site
      • Nyborg, Denmark
        • Research Site
      • Nykøbing F., Denmark
        • Research Site
      • Nærum, Denmark
        • Research Site
      • Næstved, Denmark
        • Research Site
      • Nørre-Alslev, Denmark
        • Research Site
      • Nørresundby, Denmark
        • Research Site
      • Odense C, Denmark
        • Research Site
      • Odense NV, Denmark
        • Research Site
      • Oksbøl, Denmark
        • Research Site
      • Randers, Denmark
        • Research Site
      • Redsted M., Denmark
        • Research Site
      • Ringsted, Denmark
        • Research Site
      • Risskov, Denmark
        • Research Site
      • Roskilde, Denmark
        • Research Site
      • Rudkøbing, Denmark
        • Research Site
      • Rungsted Kyst, Denmark
        • Research Site
      • Rødovre, Denmark
        • Research Site
      • Saltum, Denmark
        • Research Site
      • Skibby, Denmark
        • Research Site
      • Slagelse, Denmark
        • Research Site
      • Stensved, Denmark
        • Research Site
      • Struer, Denmark
        • Research Site
      • Sulsted, Denmark
        • Research Site
      • Svendborg, Denmark
        • Research Site
      • Sæby, Denmark
        • Research Site
      • Sønderborg, Denmark
        • Research Site
      • Søndersø, Denmark
        • Research Site
      • Thorsø, Denmark
        • Research Site
      • Tåstrup, 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, Denmark
        • Research Site
      • Åbenrå, Denmark
        • Research Site
      • Ålborg, Denmark
        • Research Site
      • Ålbæk, Denmark
        • Research Site
      • Ålestrup, Denmark
        • Research Site
      • Århus C, Denmark
        • Research Site
      • Ølstykke, Denmark
        • Research Site
  • Finland
      • 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
      • Mikkeli, Finland
        • Research Site
      • Muhos, Finland
        • Research Site
      • Mäntsälä, 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, Finland
        • Research Site
  • Norway
      • Aksdal, Norway
        • Research Site
      • Arendal, 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
      • Lysaker, Norway
        • Research Site
      • Lørenskog, Norway
        • Research Site
      • Løvenstad, Norway
        • Research Site
      • Molde, Norway
        • Research Site
      • Nesbru, Norway
        • Research Site
      • Nesttun, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Paradis, Norway
        • Research Site
      • ROA, Norway
        • Research Site
      • Rykkinn, Norway
        • Research Site
      • Rådal, Norway
        • Research Site
      • SKI, Norway
        • Research Site
      • Sandvika, Norway
        • Research Site
      • Skedsmokorset, Norway
        • Research Site
      • Skien, Norway
        • Research Site
      • Slependen, Norway
        • Research Site
      • Spikkestad, Norway
        • Research Site
      • Steinkjer, Norway
        • Research Site
      • Straume, Norway
        • Research Site
      • Strømmen, Norway
        • Research Site
      • Svelvik, Norway
        • Research Site
      • Søgne, Norway
        • Research Site
      • Sørumsand, Norway
        • Research Site
      • Tolvsrød, Norway
        • Research Site
      • Trollåsen, Norway
        • Research Site
      • Tromsø, Norway
        • Research Site
      • Trondheim, Norway
        • Research Site
      • Ulset, Norway
        • Research Site
      • Årnes, Norway
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to first severe asthma exacerbation

Secondary Outcome Measures

Outcome Measure
Mean use of as-needed medication
Number of asthma exacerbations
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

October 18, 2005

First Submitted That Met QC Criteria

October 19, 2005

First Posted (Estimate)

October 20, 2005

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5890L00008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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