CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 8,424 enrolled
Drug / intervention
Budesonide/formoteroldrug
Likely dose
Budesonide/formoterol (dose not specified)AI-extracted
Key inclusion· 5
  • ✓Age ≥18 years
  • ✓Persistent asthma with ≥6 months documented history
  • ✓Current inhaled glucocorticosteroid use for ≥1 month
  • ✓History of rapid-acting beta-2 agonist use for symptom relief
Key exclusion· 4
  • ✕Asthma exacerbation within 14 days prior to study start
  • ✕Age >40 years with smoking history >10 pack-years
  • ✕Chronic obstructive pulmonary disease (COPD)
  • ✕Other significant respiratory disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00463866
NCT00463866Phase 4Completed
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Local Phase 4 Pan-European SMART Study

AstraZeneca·interventional·Posted Apr 20, 2007·Updated Mar 22, 2010

In Brief

A Phase 4 clinical trial evaluating Budesonide/formoterol for Asthma. Completed, enrolled 8,424 participants across 817 sites in 14 countries.

Detailed Summary

The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesBelgium, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Netherlands, Norway, Russia, Spain, Sweden, United Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 20, 2007
Enrollment StartMar 1, 2007
Study CompletionDec 1, 2008
TodayJul 2, 2026
Posted 19.2 years ago

Interventions

Budesonide/formoteroldrug