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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
ClinicalTrials.gov Identifier:
NCT00404547
First received: November 27, 2006
Last updated: May 4, 2012
Last verified: March 2010
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
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 ]

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

3.  Secondary:   Assessment of Patient Compliance During the Study   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Assessment of Patient Treatment Satisfaction   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  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:
unchecked 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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