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

This study has been terminated.

Study NCT00385593 Information provided by AstraZeneca

First Received on October 6, 2006. Last Updated on November 30, 2010 History of Changes

Results First Received: October 14, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Asthma, Bronchial
Interventions:	Drug: Symbicort (budesonide/formoterol) Turbuhaler Drug: Conventional treatment

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
654

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
SMART	Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
Conv. Best Practice	Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.

Participant Flow: Overall Study

	SMART	Conv. Best Practice
STARTED	328	326
COMPLETED	270	289
NOT COMPLETED	58	37
Adverse Event	3	2
Withdrawal by Subject	17	7
Lost to Follow-up	12	8
Protocol Violation	7	4
Several reasons	17	15
Incorrect inclusion	2	0
Incorrect randomization	0	1

Baseline Characteristics

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Reporting Groups

	Description
SMART	Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
Conv. Best Practice	Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.

Baseline Measures

	SMART	Conv. Best Practice	Total
Number of Participants [units: participants]	328	326	654
Age [units: Years] Mean ± Standard Deviation	43.7 ± 16.4	44.3 ± 16.5	44.0 ± 16.5
Gender [units: Participants]
Female	218	202	420
Male	110	124	234

Outcome Measures

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1. Primary:

Time to First Severe Asthma Exacerbation [ Time Frame: Baseline up to 6 months ]

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2. Secondary:

Total Number of Severe Exacerbations [ Time Frame: Baseline up to 6 months ]

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3. Secondary:

Mean Use of as Needed Medication [ Time Frame: Baseline up to 6 months ]

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4. Secondary:

Use of Inhaled Steroids [ Time Frame: Baseline up to 6 months ]

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5. Secondary:

Change in the Asthma Control Questionnaire(ACQ) Score [ Time Frame: Daily 14 days prior to each of visit 2-4 ]

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6. Secondary:

Peak Expiratory Flow (PEF) [ Time Frame: 6 months (end of the study) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was prematurely stopped, because it was not possible to recruit the sample size required in the period of time established.

Results Point of Contact:

Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com

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