Phase 2 Study in Adults Sensitized to Cat

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antigen Laboratories, Inc.
ClinicalTrials.gov Identifier:
NCT00689299
First received: May 30, 2008
Last updated: February 27, 2014
Last verified: February 2014
Results First Received: May 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Allergy
Interventions: Biological: Standardized Allergenic Extract, Cat Hair
Biological: 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
Placebo Maintenance dose of 0.15 mL of liquid placebo administered as a daily oral liquid via sublingual route.
2.1 Units Fel d 1

Active Dose Group B

From a concentration of 14.0 Units/mL of Fel d 1, a maintenance dose of 0.15 mL (2.1 Units Fel d 1) was administered as a daily oral liquid via sublingual route.

0.21 Units Fel d 1

Active Dose Group A

From a concentration of 14.0 Units/mL of Fel d 1 diluted 1:10 v/v, a maintenance dose of 0.15 mL (0.21 Units Fel d 1) was administered as a daily oral liquid via sublingual route.


Participant Flow:   Overall Study
    Placebo     2.1 Units Fel d 1     0.21 Units Fel d 1  
STARTED     58     57     54  
COMPLETED     51     54     49  
NOT COMPLETED     7     3     5  
Adverse Event                 2                 1                 1  
Lost to Follow-up                 0                 1                 1  
Withdrawal by Subject                 4                 1                 3  
Protocol Violation                 1                 0                 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
Placebo Placebo - Dose Group C
0.21 Units Fel d 1 Standardized Allergenic Extract, Cat Hair ( Active Dose Group A
2.1 Units Fel d 1 Standardized Allergenic Extract, Cat Hair (F Active Dose Group B
Total Total of all reporting groups

Baseline Measures
    Placebo     0.21 Units Fel d 1 Standardized Allergenic Extract, Cat Hair (     2.1 Units Fel d 1 Standardized Allergenic Extract, Cat Hair (F     Total  
Number of Participants  
[units: participants]
  58     54     57     169  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     58     54     57     169  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  34  ± 9     36  ± 8     33  ± 9     34.5  ± 9  
Gender  
[units: participants]
       
Female     39     33     38     110  
Male     19     21     19     59  
Region of Enrollment  
[units: participants]
       
United States     58     54     57     169  



  Outcome Measures

1.  Primary:   Scores on a Scale (Average of Total Symptom Scores)   [ Time Frame: 20 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


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
Adverse events: 41%, 58%, and 45% > 5% in Group A, B, and C, respectively.  


Results Point of Contact:  
Name/Title: Mark Hites
Organization: Greer Laboratories, Inc. for Antigen Laboratories, Inc.
phone: 828-759-7548
e-mail: mhites@greerlabs.com


No publications provided


Responsible Party: Antigen Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00689299     History of Changes
Other Study ID Numbers: ALI002-08
Study First Received: May 30, 2008
Results First Received: May 24, 2011
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration