Efficacy of SLITone in House Dust Mite Allergic Patients

This study has been completed.
Sponsor:
Information provided by:
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT00633919
First received: March 4, 2008
Last updated: June 7, 2011
Last verified: June 2011
Results First Received: November 11, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Allergy
Interventions: Biological: SLITone(TM) Dermatophagoides mix
Biological: Placebo
Drug: Salbutamol inhaler
Drug: Budesonide/formoterol inhaler
Drug: Prednisone tablet
Drug: Desloratadine tablet
Drug: Budesonide nasal spray

  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
First subject first visit: 22 June 2006

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Active SLITone Dermatophagoides Mix
Placebo SLITone Placebo

Participant Flow:   Overall Study
    Active     Placebo  
STARTED     63     61  
COMPLETED     36     39  
NOT COMPLETED     27     22  



  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
Active SLITone Dermatophagoides Mix
Placebo SLITone Placebo
Total Total of all reporting groups

Baseline Measures
    Active     Placebo     Total  
Number of Participants  
[units: participants]
  63     61     124  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     63     61     124  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  32  ± 8.0     30  ± 9.0     31  ± 8.6  
Gender  
[units: participants]
     
Female     39     39     78  
Male     24     22     46  
Region of Enrollment  
[units: participants]
     
Spain     63     61     124  



  Outcome Measures
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1.  Primary:   Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2008   [ Time Frame: 8 weeks ]

2.  Secondary:   Average Daily Asthma Medication Score During a 2-months Evaluation Period in Autumn 2007   [ Time Frame: 8 weeks ]

3.  Secondary:   Global Evaluation of Efficacy by Subject at the End of The Evaluation Period in 2008   [ Time Frame: 8 weeks ]

4.  Secondary:   Global Evaluation of Efficacy by Investigator at the End of the Evaluation Period in Autumn 2008   [ Time Frame: 8 weeks ]

5.  Secondary:   Global Evaluation of Efficacy by Subject and Investigator at the End of the Evaluation Period in Autumn 2007   [ Time Frame: 8 weeks ]


  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
Retrospectively, trial design (medication use did not reflect the asthma status of subjects), and subject number (low power) and characteristics (mild, well-controlled asthma; low medication use needed) were not optimal for this trial purpose.


  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 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.


Results Point of Contact:  
Name/Title: Santiago Martín - Trial Manager
Organization: ALK-Abelló S.A.
phone: +34 913276127
e-mail: santiago.martin@alk-abello.com


No publications provided


Responsible Party: Santiago Martín -Trial Manager; ALK-Abelló S.A., ALK-Abelló S.A.
ClinicalTrials.gov Identifier: NCT00633919     History of Changes
Other Study ID Numbers: E02/04/SLIT1-M, EudraCT - 2005-004731-21
Study First Received: March 4, 2008
Results First Received: November 11, 2010
Last Updated: June 7, 2011
Health Authority: Spain: Spanish Agency of Medicines