A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma (PASSION)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00628758

First received: January 10, 2008

Last updated: July 6, 2012

Last verified: July 2012

History of Changes

Results First Received: September 18, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Asthma
Interventions:	Drug: Symbicort TBH - Turbuhaler Drug: beta-II-agonist, inhale steroid

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
FSI: LSI: LSO: Center type: Research and Training Host, Chest Medicine and Internal Medicine 23 Clinics. Number of enrolled subjects: 432, randomized: 430, completed patients: 344 ( Arm A:165, Arm B 179)

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
Symbicort	Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
Conventional BP	Conventional Best Practice for Treatment of asthma

Participant Flow: Overall Study

	Symbicort	Conventional BP
STARTED	209	221
COMPLETED	165	179
NOT COMPLETED	44	42
Adverse Event	2	3
Withdrawal by Subject	6	3
Death	1	0
Protocol Violation	5	1
Lost to Follow-up	25	31
Pregnancy	2	2
Investigator Moved	3	0
Treatment Failure	0	2

Baseline Characteristics

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Reporting Groups

	Description
Symbicort	Symbicort Single Inhaler Therapy ( Turbohaler 160/4.5 microg, 1 inh bid + as need)
Conventional BP	Conventional Best Practice for Treatment of asthma
Total	Total of all reporting groups

Baseline Measures

	Symbicort	Conventional BP	Total
Number of Participants [units: participants]	209	221	430
Age [units: years] Mean ± Standard Deviation	44.28 ± 12.09	45.17 ± 12.71	44.7 ± 12.4
Gender [units: Participants]
Female	157	179	336
Male	52	42	94

Outcome Measures

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1. Primary:

Time to First Severe Asthma Exacerbation [ Time Frame: 26 weeks ]

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2. Secondary:

Number of Severe Asthma Exacerbations [ Time Frame: 26 weeks ]

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3. Secondary:

Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score [ Time Frame: Baseline and 26 weeks ]

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4. Secondary:

Mean Use of As-needed Medication Per Day During Treatment Period [ Time Frame: Daily recording during the treatment period of 26 weeks ]

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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
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Results Point of Contact:

Name/Title: Gerard Lynch
Organization: AstraZeneca
phone: +44 1509 645895
e-mail: aztrial_results_posting@astrazeneca.com

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00628758 History of Changes
Other Study ID Numbers:	D5890L00016
Study First Received:	January 10, 2008
Results First Received:	September 18, 2009
Last Updated:	July 6, 2012
Health Authority:	Turkey: Ministry of Health

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