Proof of Activity Study of UR-63325 in Allergic Rhinitis Induced by Nasal Challenge

Double Blind Randomised Placebo and Active Controlled, Proof of Activity Study of UR-63325 in Allergic Rhinitis Induced by Nasal Challenge to Allergic Patients Otherwise Healthy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01260753

Enrollment

Registered

2010-12-15

Start date

2010-12-31

Completion date

2011-03-31

Last updated

2011-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal Allergic Rhinitis

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.

Interventions

DRUGUR-63325

UR-63325

DRUGFluticasone propionate nasal spray

Fluticasone propionate nasal spray

DRUGPlacebo

Placebo to UR 63325 and fluticasone propionate nasal spray

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* 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 criteria

* 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

Design outcomes

Primary

Measure	Time frame
Nasal and ocular symptoms scores after nasal allergen challenge	24 hours

Secondary

Measure	Time frame
Inflammatory parameters measured from nasal exudate	24 hours

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026