Clinical trial NCT00463866: Local Phase 4 Pan-European SMART Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-04-20
Enrollment: 8424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

* Patients at out-patient clinics
* \>18 years with a minimum of 6 months documented history of persistent asthma who have used inhaled glucocorticosteroids for at least one month and have a history of use in rapid-acting B2 agonists for symptom relief

Exclusion Criteria:

* Asthma exacerbation within the last 14 days prior to study start
* subject aged \>40 years with a smoking history of \>10pack-years
* subjects with chronic obstructive lung disease or other significant respiratory disease

Primary outcomes:
measure: Number of Severe Asthma Exacerbations Per Participant.
timeFrame: 6 months
Secondary outcomes:
measure: Fraction of Participants With Severe Asthma Exacerbation
timeFrame: 6 months.
measure: Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment.
timeFrame: 6 months.
measure: Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation
timeFrame: 6 months.
measure: Mean Daily Number of Inhalations of As-needed Medication.
timeFrame: 4 weeks
measure: Percent of Participants With a Well Controlled Asthma Week.
timeFrame: 6 months.
measure: Mean Overall Asthma Control Questionnaire (ACQ) Score
timeFrame: 6 months.
measure: The Mean Total Daily Dose of Steroids From Symbicort.
timeFrame: 4 weeks
measure: Mean Cost Per Participant Per Country
timeFrame: 6 months
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Research Site
city: Aarschot
country: Belgium
facility: Research Site
city: Aatrijken
country: Belgium
facility: Research Site
city: Asse
country: Belgium
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facility: Research Site
city: Weston-Super-Mare
country: United Kingdom
facility: Research Site
city: Whitstable
country: United Kingdom
facility: Research Site
city: Wishaw
country: United Kingdom
facility: Research Site
city: Yaxley
country: United Kingdom
facility: Research Site
Study officials:
affiliation: FRANCE
name: Michel Aubier, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca, MC France
name: Juliette Ostinelli, MD
role: STUDY_CHAIR
References:
citation: Aubier M, Haughney J, Selroos O, van Schayck OC, Ekstrom T, Ostinelli J, Buhl R. Is the patient's baseline inhaled steroid dose a factor for choosing the budesonide/formoterol maintenance and reliever therapy regimen? Ther Adv Respir Dis. 2011 Oct;5(5):289-98. doi: 10.1177/1753465811407236. Epub 2011 May 17.
citation: Haughney J, Aubier M, Jorgensen L, Ostinelli J, Selroos O, van Schayck CP, Buhl R. Comparing asthma treatment in elderly versus younger patients. Respir Med. 2011 Jun;105(6):838-45. doi: 10.1016/j.rmed.2011.02.011. Epub 2011 Mar 23.
citation: Aubier M, Buhl R, Ekstrom T, Ostinelli J, van Schayck CP, Selroos O, Haughney J. Comparison of two twice-daily doses of budesonide/formoterol maintenance and reliever therapy. Eur Respir J. 2010 Sep;36(3):524-30. doi: 10.1183/09031936.00022010. Epub 2010 Jul 1.