Status:
COMPLETED
Proof of Activity Study of UR-63325 in Allergic Rhinitis Induced by Nasal Challenge
Lead Sponsor:
Palau Pharma S.L.U.
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
MALE
18-55 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to explore the activity of UR-63325 in a model of allergic rhinitis induced by nasal allergen challenge to known allergic rhinitis patients otherwise healthy.
Eligibility Criteria
Inclusion
- Provision of written informed consent to participate (prior to any study-related procedures being performed) as shown by a signature on the volunteer consent form and to be able to adhere to the study restrictions and examination schedule
- Subjects with confirmed history of seasonal allergic rhinitis to grass pollen (by direct questioning of presence of positive skin prick test to pollen and History of Symptoms of allergic rhinitis) within the previous two years
- Positive skin prick test to timothy grass pollen (wheal difference with negative control ≥ 3 mm) at screening
- Subjects with positive response to screening nasal challenge with increasing doses of timothy grass pollen (Symptoms worsening with respect to the response to the diluent challenge of ≥4 points in the total nasal symptom score \[TNSS\]) within one hour after last nasal allergen challenge
- Screening and baseline FEV1 \>80% predicted and FEV1/FVC \> 70% predicted
Exclusion
- Symptoms of allergic rhinitis within 2 weeks prior to screening
- Upper respiratory infection or sinusitis within 14 days of screening and also within 14 days of study start in each of the two periods
- Structural nasal abnormalities or nasal polyps on examination, a history of nose bleeding or recent nasal surgery
- History of asthma or asthmatic symptoms or other respiratory disease other than rhinitis within the last 2 years or FEV1\<80% of predicted at screening or baseline
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01260753
Start Date
December 1 2010
End Date
March 1 2011
Last Update
April 15 2011
Active Locations (1)
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1
Parexel International GmbH
Berlin, Germany, 14050