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Effects of Intranasal Corticosteroid and Montelukast On Nasal Allergen Challenges* (Roche)

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: NCT01240889
Recruitment Status : Completed
First Posted : November 15, 2010
Last Update Posted : October 10, 2012
Roche Pharma AG
Information provided by:
Creighton University

Brief Summary:
This study will be a randomized, double blind, placebo-controlled, parallel group study and will include subjects with ragweed-induced seasonal allergic rhinitis.

Condition or disease Intervention/treatment Phase
Allergy Drug: Fluticasone Drug: Fluticason Not Applicable

Detailed Description:
The primary goal of this proposal is to assess the ability of an intranasal corticosteroid, fluticasone, and montelukast to affect the upper airway and systemic physiologic, biologic and clinical parameters occurring after an early and late upper airway allergic response to ragweed in ragweed allergic rhiniticsThe assessment of early allergy responses in the nose has been fairly well established in our laboratory and we will use methods detailed in previous publications (21, 23 24). One potential challenge will be to sample upper airway mediators and cytokines without affecting clinical parameters such as symptom scores and acoustic rhinometry readings. Moreover, we will need to sample at time points throughout six or more hours in order to accurately determine the effects on late phase allergic responses. Nasal filter paper sampling is a technique that we are currently engaged in using, and we will work with Roche to elute the samples and measure multiple mediators and cytokines.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Intranasal Corticosteroid and Montelukast On Nasal Allergen Challenges*
Study Start Date : November 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: montelukast
luekotriene inhibitor
Drug: Fluticasone
nasal spray

Active Comparator: Fluticasone
Nasal steroid
Drug: Fluticason
2 sprays per day in each nostril

Primary Outcome Measures :
  1. Effect of nasal allergen challenges on biomarkers [ Time Frame: December 2011 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male or female subjects aged 19-60 years.
  • Females of child bearing potential must use appropriate birth control throughout the study and urine pregnancy tests must be negative prior to dosing at each study visit.
  • Subjects with a documented history of ragweed-induced seasonal allergic rhinitis requiring pharmacotherapy during the preceding 2 allergen seasons.
  • Subjects with a positive skin prick test to short ragweed (Amb a 1) extract, defined as >3mm wheal larger than saline control
  • Subjects spirometry FEV1 must be > 80% predicted prior to each allergen challenge
  • Subjects average post diluents nasal congestion score must be < 1 at admission for each study visit

Exclusion Criteria:

  • Subjects with evidence or history of clinically significant medical illnesses other than changes related to allergic rhinitis. Subjects with some stable chronic medical conditions not expected to interfere with the conduct or safety of the study may be eligible to participate based on the investigator's discretion.
  • Subjects with a history of asthma or urticaria, or a screening FEV1 prior to allergen challenge of <80% of predicted. in FEV1 compared to pre-diluent FEV1 baseline at either screening visit.
  • Subjects with significant nasal deformity, recent nasal surgery nasal polyps or chronic rhinosinusitis.
  • Subjects who have smoked in the last 6 months or have a history of >10 pack years.
  • Subjects who are taking or have taken restricted concomitant medications that could confound the safety or efficacy assessments including those shown below.
  • Subjects who have history or evidence of alcohol or drug abuse.
  • Subjects exposed to cat and have a positive skin test to cat.
  • Subjects that have a positive skin test to dust mite (D pteronyssinus/ D farinae) requiring pharmacotherapy

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): NCT01240889

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United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Roche Pharma AG
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Principal Investigator: Thomas B Casale, MD Creighton University
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Responsible Party: Thomas B. Casasle, MD, Creighton University Identifier: NCT01240889    
Other Study ID Numbers: 10-15912
First Posted: November 15, 2010    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012
Keywords provided by Creighton University:
Ragweed allergies
acoustic rhinometry
nasal allergen challenge
Additional relevant MeSH terms:
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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