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Trial record 47 of 248 for:    test AND provocation

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00574704
Recruitment Status : Completed
First Posted : December 17, 2007
Results First Posted : July 11, 2013
Last Update Posted : July 11, 2013
Sponsor:
Information provided by (Responsible Party):
Cytos Biotechnology AG

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AllQbG10 Allergen QbG10 Placebo
Hide Arm/Group Description CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
Period Title: Overall Study
Started 10 10 10 10
Completed 10 10 9 10
Not Completed 0 0 1 0
Arm/Group Title AllQbG10 Allergen QbG10 Placebo Total
Hide Arm/Group Description CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits Total of all reporting groups
Overall Number of Baseline Participants 10 10 10 10 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 10 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
10
 100.0%
10
 100.0%
40
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 10 participants 10 participants 40 participants
34.2  (8.6) 36.5  (9.8) 36.8  (11.0) 31.0  (15.9) 34.6  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 10 participants 40 participants
Female
3
  30.0%
6
  60.0%
3
  30.0%
4
  40.0%
16
  40.0%
Male
7
  70.0%
4
  40.0%
7
  70.0%
6
  60.0%
24
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Europe Number Analyzed 10 participants 10 participants 10 participants 10 participants 40 participants
10 10 10 10 40
1.Primary Outcome
Title 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)
Hide Description

The outcome measure is a conjunctival provocation test (CPT) with house dust mite allergen solutions. CPT score was measured as a sum of the following assessed symptoms: conjunctival hyperemia, tearing, itching, burning and swelling of eyelids. Each of the assessed symptom could be absent (0), mild (1 point), moderate (2 points) or severe (3 points). The provocation tests started with the maximal dilution of the allergen 1:1000. If the sum of the reached CPT score was <10 points, the test continued with the next dilution step 1:100. This procedure was repeated until patients reached the CPT score ≥ 10 points or the provocation solution reached the maximal concentration 1:1 (undiluted).

The outcome is then given as the change of median individual allergen tolerance at month two compared to baseline. The change is expressed as a factor of increase in allergen concentration to induce a threshold CPT score ≥ 2.

Time Frame baseline versus 2 months after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AllQbG10 Allergen QbG10 Placebo
Hide Arm/Group Description:
CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
Overall Number of Participants Analyzed 10 10 10 10
Median (Inter-Quartile Range)
Unit of Measure: Factor of Increased Allergen Tolerance
10
(1.0 to 100.0)
10
(1.0 to 10.0)
10
(1.0 to 10.0)
1
(0.1 to 10.0)
2.Secondary Outcome
Title Safety and Tolerability of the Study Treatment by Collection of Adverse Events
Hide Description [Not Specified]
Time Frame about 30 min. at each visit
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AllQbG10 Allergen QbG10 Placebo
Hide Arm/Group Description CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
All-Cause Mortality
AllQbG10 Allergen QbG10 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AllQbG10 Allergen QbG10 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/10 (10.00%)   0/10 (0.00%)   0/10 (0.00%)   0/10 (0.00%) 
Injury, poisoning and procedural complications         
fracture of right malleolus (accident)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AllQbG10 Allergen QbG10 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/10 (80.00%)   10/10 (100.00%)   8/10 (80.00%)   10/10 (100.00%) 
Eye disorders         
Conjunctivitis allergic  1/10 (10.00%)  2/10 (20.00%)  1/10 (10.00%)  2/10 (20.00%) 
Gastrointestinal disorders         
Diarrhea  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  2/10 (20.00%) 
General disorders         
Local reactions  2/10 (20.00%)  2/10 (20.00%)  1/10 (10.00%)  0/10 (0.00%) 
Infections and infestations         
Nasopharyngitis  4/10 (40.00%)  1/10 (10.00%)  4/10 (40.00%)  5/10 (50.00%) 
Influenza  3/10 (30.00%)  3/10 (30.00%)  0/10 (0.00%)  0/10 (0.00%) 
Rhinitis  0/10 (0.00%)  1/10 (10.00%)  2/10 (20.00%)  1/10 (10.00%) 
Nervous system disorders         
Headache  1/10 (10.00%)  0/10 (0.00%)  1/10 (10.00%)  1/10 (10.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma  3/10 (30.00%)  2/10 (20.00%)  0/10 (0.00%)  1/10 (10.00%) 
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.
Results Point of Contact
Name/Title: Head of Clinical Develpment
Organization: Cytos Biotechnology AG
Phone: +41 44 733 4 ext 7 47
Responsible Party: Cytos Biotechnology AG
ClinicalTrials.gov Identifier: NCT00574704     History of Changes
Other Study ID Numbers: CYT005-AllQbG10 03
First Submitted: December 14, 2007
First Posted: December 17, 2007
Results First Submitted: February 14, 2013
Results First Posted: July 11, 2013
Last Update Posted: July 11, 2013