Asthma Care With Alvesco® (Ciclesonide) in Primary Care in Adults - The ACCEPT-study (BY9010/CA-102)

This study has been completed.

Sponsor:

Information provided by:

Takeda Global Research & Development Center, Inc.

ClinicalTrials.gov Identifier:

NCT00404547

First received: November 27, 2006

Last updated: May 4, 2012

Last verified: March 2010

History of Changes

Results First Received: March 8, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Asthma
Interventions:	Drug: Ciclesonide Drug: Usual Care Inhaled Glucocorticosteroids

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The number of subjects STARTED is related to the number of randomized subjects (= subjects who were eligible for treatment period). It differs from the number of subjects of the Intention to Treat (ITT) population in Baseline Characteristics and Outcome Measures. The statistical analyses of the Outcome Measures is based on the ITT population.

Reporting Groups

	Description
Alvesco	320 mcg/day or 640 mcg/day
Usual Asthma Care and Dosage	as chosen by the Primary Care Physician

Participant Flow: Overall Study

	Alvesco	Usual Asthma Care and Dosage
STARTED	762	359
COMPLETED	672	334
NOT COMPLETED	90	25
Adverse Event	39	6
Withdrawal by Subject	19	2
Protocol Violation	0	1
Lost to Follow-up	20	9
Lack of compliance	5	1
Not known	4	0
Reason not stated	3	6

Baseline Characteristics

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Reporting Groups

	Description
Alvesco	320 mcg/day or 640 mcg/day
Usual Asthma Care and Dosage	as chosen by the Primary Care Physician
Total	Total of all reporting groups

Baseline Measures

	Alvesco	Usual Asthma Care and Dosage	Total
Number of Participants [units: participants]	712	345	1057
Age, Customized ^[1] [units: years] Mean ± Standard Deviation	47.3 ± 16.3	47.2 ± 16.7	47.26 ± 16.43
Gender ^[1] [units: participants]
Female	431	232	663
Male	281	113	394
Smoking Status ^[1] [units: participants]
Never	359	149	508
Current	156	81	237
Former	197	115	312
Duration of Asthma ^[1] [units: years] Mean ± Standard Deviation	12.4 ± 11.3	12.8 ± 11.9	12.5 ± 11.4

[1]	Basis is the Intention to Treat Population (ITT).

Outcome Measures

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1. Primary:

Change in Mean of Total Score of Asthma Control Questionnaire (ACQ) [ Time Frame: At the middle and end of the 12 week treatment period ]

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2. Secondary:

Change in Patient Assessment of Asthma Control [ Time Frame: At baseline and at week 12 ]

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3. Secondary:

Assessment of Patient Compliance During the Study [ Time Frame: 12 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

4. Secondary:

Assessment of Patient Treatment Satisfaction [ Time Frame: 12 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

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 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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI 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: Respiratory Medical Advisor
Organization: Nycomed GmbH
phone: 0049-7531-840
e-mail: clinicaltrials@nycomed.com

No publications provided

Responsible Party:	Nycomed GmbH (Ex ALTANA Pharma)
ClinicalTrials.gov Identifier:	NCT00404547 History of Changes
Other Study ID Numbers:	BY9010/CA-102
Study First Received:	November 27, 2006
Results First Received:	March 8, 2010
Last Updated:	May 4, 2012
Health Authority:	Canada: Ethics Review Committee

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