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:

Drug Information available for: Budesonide Formoterol

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	Carlos Barcina, MD	AstraZeneca

More Information


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 Formoterol Fumarate Budesonide Budesonide, Formoterol Fumarate Drug Combination Bronchodilator Agents Autonomic Agents	Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 30, 2016