Local Phase 4 Pan-European SMART Study - Full Text View

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: Budesonide/formoterol	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Budesonide Formoterol Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Number of Severe Asthma Exacerbations Per Participant. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.

Secondary Outcome Measures:

Fraction of Participants With Severe Asthma Exacerbation [ Time Frame: 6 months. ] [ Designated as safety issue: No ]
The total number of severe asthma exacerbations was calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.
Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment. [ Time Frame: 6 months. ] [ Designated as safety issue: No ]
A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. Number of events per participant
Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation [ Time Frame: 6 months. ] [ Designated as safety issue: No ]
Total number of days with oral/systemic glucocorticosteroids during severe exacerbation calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.
Mean Daily Number of Inhalations of As-needed Medication. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The number of as-needed inhalations was measured 2 times during 2 weeks before 13 weeks and 26 weeks of treatment.
Percent of Participants With a Well Controlled Asthma Week. [ Time Frame: 6 months. ] [ Designated as safety issue: No ]
The mean percent of participants fulfilling the criteria for a well controlled asthma week in each treatment. A well controlled asthma week is defined as a week with no exacerbations and no night-time awakenings due to asthma and a maximum of 2 days with symptoms and as-needed inhalation use.
Mean Overall Asthma Control Questionnaire (ACQ) Score [ Time Frame: 6 months. ] [ Designated as safety issue: No ]
The ACQ5 was used. The lower value the better with a full range from 0=no impairment, 6= maximum impairment. Awakenings, morning symptoms, limitations, shortness of breath and wheeze.
The Mean Total Daily Dose of Steroids From Symbicort. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The mean total daily dose of steroids from Symbicort was calculated as the sum of the maintenance dose and the as-needed dose.
Mean Cost Per Participant Per Country [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Mean cost is calculated for each country using participants from the whole study and country specific costs. Mean value for the whole study can not be calculated.

Enrollment:	8424
Study Start Date:	March 2007
Study Completion Date:	December 2008

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463866

Show 819 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Michel Aubier, Prof	FRANCE
Study Chair:	Juliette Ostinelli, MD	AstraZeneca, MC France

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Aubier M, Haughney J, Selroos O, van Schayck OC, Ekström 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. Epub 2011 May 17.

Haughney J, Aubier M, Jørgensen 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. Epub 2011 Mar 23.

Aubier M, Buhl R, Ekström 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. Epub 2010 Jul 1.

ClinicalTrials.gov Identifier:	NCT00463866 History of Changes
Other Study ID Numbers:	D5890L00022, EUROSMART, EudraCTNo. 2006-006512-30
Study First Received:	April 19, 2007
Results First Received:	December 22, 2009
Last Updated:	March 8, 2010
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Greece: National Organization of Medicines Ireland: Irish Medicines Board Italy: Ethics Committee Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Norway:National Committee for Medical and Health Research Ethics Russia: Ministry of Health of the Russian Federation Spain: Spanish Agency of Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Asthma

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013