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

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT01240889
First received: October 28, 2010
Last updated: October 8, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention
Allergy
Drug: Fluticasone
Drug: Fluticason

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Intranasal Corticosteroid and Montelukast On Nasal Allergen Challenges*

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Effect of nasal allergen challenges on biomarkers [ Time Frame: December 2011 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: November 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: montelukast
luekotriene inhibitor
Drug: Fluticasone
nasal spray
Active Comparator: Fluticasone
Nasal steroid
Drug: Fluticason
2 sprays per day in each nostril

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.

  Eligibility

Ages Eligible for Study:   19 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01240889

Locations
United States, Nebraska
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Roche Pharma AG
Investigators
Principal Investigator: Thomas B Casale, MD Creighton University
  More Information

Publications:
Responsible Party: Thomas B. Casasle, MD, Creighton University
ClinicalTrials.gov Identifier: NCT01240889     History of Changes
Other Study ID Numbers: 10-15912
Study First Received: October 28, 2010
Last Updated: October 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
Ragweed allergies
acoustic rhinometry
nasal allergen challenge

Additional relevant MeSH terms:
Fluticasone
Montelukast
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 16, 2014