Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults - Full Text View

Purpose

This study is intended to extend the knowledge of Symbicort Single Inhaler Therapy into a more general setting in order to assess the real-life impact of introducing this new treatment concept. The study will compare the Symbicort Single Inhaler Therapy concept with a conventional stepwise treatment regimen according to the investigator's judgement in patients who present with symptoms on inhaled glucocorticosteroids (GCS) treatment or who require and are already on treatment with a combination of inhaled and long-acting B2 agonists (LABA).

Condition	Intervention	Phase
Asthma, Bronchial	Drug: Symbicort (budesonide/formoterol) Turbuhaler Drug: Conventional treatment	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 Micrograms, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults - a 26-week, Randomised, Open-label, Parallel-group, Multicentre Study. Study SPAIN

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:

Time to First Severe Asthma Exacerbation [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: No ]
Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral Glucocorticosteroids (GCS) treatment for at least 3 days.

Secondary Outcome Measures:

Total Number of Severe Exacerbations [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: No ]
Severe asthma exacerbation is defined as deterioration in asthma leading to at least one of Hospitalization/Emergency room (or equivalent) treatment due to asthma or Oral (GCS) treatment for at least 3 days.
Mean Use of as Needed Medication [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: No ]
Mean use of as needed medication during the treatment period
Use of Inhaled Steroids [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: No ]
Mean micrograms/day of inhaled steroids (beclomethasone dipropionate equivalents)
Change in the Asthma Control Questionnaire(ACQ) Score [ Time Frame: Daily 14 days prior to each of visit 2-4 ] [ Designated as safety issue: No ]
The ACQ is a 7-point scale with scores ranging from 0 (very well controlled) to 6 (very badly controlled)
Peak Expiratory Flow (PEF) [ Time Frame: 6 months (end of the study) ] [ Designated as safety issue: No ]
Peak expiratory flow (PEF)

Enrollment:	654
Study Start Date:	September 2006
Study Completion Date:	October 2008

Eligibility

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

Criteria

Inclusion Criteria:

Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition (9).
Prescribed inhaled GCS at a dose of 400μg/day of budesonide (or equivalents)and within the approved label for the relevant drug during the last 3 months prior to Visit 1.
Either daily maintenance treatment with both inhaled GCS and LABA or daily treatment with inhaled GCS alone (i.e. without LABA)
A history of suboptimal asthma control the month prior to enrolment as judged by the investigator
Use of ≥3 inhalations of as needed medication for symptom relief during the last 7 days before enrolment

Exclusion Criteria:

Previous treatment with Symbicort Single Inhaler;
Use of any b-blocking agent, including eye-drops and oral GCS as maintenance treatment.
Known or suspected hypersensitivity to study therapy or excipients.
A history of smoking ≥ 10 pack years.
Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at Visit 1.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385593

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Locations

Spain
Research Site
A Coruna, Spain
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Alagon, Spain
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Alicante, Spain
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Almoradi, Spain
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Barcelona, Spain
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Burgos, Spain
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Cadiz, Spain
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Caravaca, Spain
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Cartagena, Spain
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Cordoba, Spain
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Coslada, Spain
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Dos Hermanas, Spain
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Elche, Spain
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Fuencarral, Spain
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Fuenlabrada, Spain
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Galdacano, Spain
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Gallur, Spain
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Gandia, Spain
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Getafe, Spain
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Gijon, Spain
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Granada, Spain
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Huelva, Spain
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Huesca, Spain
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Idiazabal, Spain
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Jaen, Spain
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Lugo, Spain
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Madrid, Spain
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Malaga, Spain
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Mataro, Spain
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Oviedo, Spain
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Pamplona, Spain
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Pinto, Spain
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Pozuelo de Alarcon, Spain
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Sagunto, Spain
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Salamanca, Spain
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San Juan, Spain
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San Sebastian, Spain
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Santander, Spain
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Santiago, Spain
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Santiago de Compostela, Spain
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Sevilla, Spain
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Terrassa, Spain
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Valdemoro, Spain
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Valencia, Spain
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Valladolid, Spain
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Vigo, Spain
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Viladecans, Spain
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Vilanova, Spain
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Villabona, Spain
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Villanueva de la Canada, Spain
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Vitoria, Spain
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Zaragoza, Spain

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Carlos Barcina, MD

AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00385593 History of Changes
Other Study ID Numbers:	D5890L00010, 2005-005974-64, SPAIN
Study First Received:	October 6, 2006
Results First Received:	October 14, 2009
Last Updated:	November 30, 2010
Health Authority:	Spain: Spanish Agency of Medicines

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 19, 2013