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A Study to Investigate an Immunomodulatory Therapy in Adult Patients With Perennial Allergic Rhinoconjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cytos Biotechnology AG
ClinicalTrials.gov Identifier:
NCT00574704
First received: December 14, 2007
Last updated: June 4, 2013
Last verified: February 2013
Results First Received: February 14, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Perennial Allergic Rhinoconjunctivitis
House Dust Mite Allergy
Interventions: Drug: CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10)
Drug: House dust mite allergen extract in combination with CYT003-QbG10-placebo
Drug: CYT003-AllQbG10 in combination with house dust mite allergen extract placebo
Drug: CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo

  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
No text entered.

Reporting Groups
  Description
AllQbG10 CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
Allergen House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
QbG10 CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
Placebo CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits

Participant Flow:   Overall Study
    AllQbG10   Allergen   QbG10   Placebo
STARTED   10   10   10   10 
COMPLETED   10   10   9   10 
NOT COMPLETED   0   0   1   0 



  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
AllQbG10 CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
Allergen House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
QbG10 CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
Placebo CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
Total Total of all reporting groups

Baseline Measures
   AllQbG10   Allergen   QbG10   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   10   10   40 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   10   10   10   10   40 
>=65 years   0   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.2  (8.6)   36.5  (9.8)   36.8  (11.0)   31.0  (15.9)   34.6  (11.5) 
Gender 
[Units: Participants]
         
Female   3   6   3   4   16 
Male   7   4   7   6   24 
Region of Enrollment 
[Units: Participants]
         
Europe   10   10   10   10   40 


  Outcome Measures

1.  Primary:   Conjunctival Provocation Test (CPT) With House Dust Mite Allergen Solutions. Change of Median Individual Allergen Tolerance Compared to Baseline (Factor of Increase in Allergen Concentration to Induce a Threshold CPT Score ≥ 2)   [ Time Frame: baseline versus 2 months after baseline ]

2.  Secondary:   Safety and Tolerability of the Study Treatment by Collection of Adverse Events   [ Time Frame: about 30 min. at each visit ]
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: Head of Clinical Develpment
Organization: Cytos Biotechnology AG
phone: +41 44 733 4 ext 7 47
e-mail: info@cytos.com



Responsible Party: Cytos Biotechnology AG
ClinicalTrials.gov Identifier: NCT00574704     History of Changes
Other Study ID Numbers: CYT005-AllQbG10 03
Study First Received: December 14, 2007
Results First Received: February 14, 2013
Last Updated: June 4, 2013
Health Authority: Switzerland: Swissmedic