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

This study has been completed.
Sponsor:
Information provided by:
Palau Pharma S.A.
ClinicalTrials.gov Identifier:
NCT01260753
First received: December 13, 2010
Last updated: April 14, 2011
Last verified: April 2011
History of Changes

December 13, 2010
April 14, 2011
December 2010
March 2011   (final data collection date for primary outcome measure)
Nasal and ocular symptoms scores after nasal allergen challenge [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Nasal and ocular symptoms scores after nasal allergen challenge [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01260753 on ClinicalTrials.gov Archive Site
Inflammatory parameters measured from nasal exudate [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Inflammatory parameters measured from nasal exudates [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Seasonal Allergic Rhinitis
  • Drug: UR-63325
    UR-63325
  • Drug: Fluticasone propionate nasal spray
    Fluticasone propionate nasal spray
  • Drug: Placebo
    Placebo to UR 63325 and fluticasone propionate nasal spray
  • Experimental: UR-63325
    Intervention: Drug: UR-63325
  • Active Comparator: Fluticasone propionate nasal spray
    Intervention: Drug: Fluticasone propionate nasal spray
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01260753
PPh/00071/10, 2010-021858-20
Not Provided
Roser Vives MD, Clinical Research Scientist, Palau Pharma S.A.
Palau Pharma S.A.
Not Provided
Principal Investigator: Rainard Fuhr, MD Parexel International GmbH
Palau Pharma S.A.
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP