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

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. Identifier: NCT01260753
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : April 15, 2011
Information provided by:
Palau Pharma S.A.

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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: UR-63325 Drug: Fluticasone propionate nasal spray Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: UR-63325 Drug: UR-63325

Active Comparator: Fluticasone propionate nasal spray Drug: Fluticasone propionate nasal spray
Fluticasone propionate nasal spray

Placebo Comparator: Placebo Drug: Placebo
Placebo to UR 63325 and fluticasone propionate nasal spray

Primary Outcome Measures :
  1. Nasal and ocular symptoms scores after nasal allergen challenge [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Inflammatory parameters measured from nasal exudate [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01260753

Parexel International GmbH
Berlin, Germany, 14050
Sponsors and Collaborators
Palau Pharma S.A.
Principal Investigator: Rainard Fuhr, MD Parexel

Responsible Party: Roser Vives MD, Clinical Research Scientist, Palau Pharma S.A. Identifier: NCT01260753     History of Changes
Other Study ID Numbers: PPh/00071/10
2010-021858-20 ( EudraCT Number )
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: April 15, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents