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

Primary Purpose

Allergy

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fluticasone

Fluticason

About this trial

This is an interventional treatment trial for Allergy focused on measuring Ragweed allergies, acoustic rhinometry, nasal allergen challenge

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Creighton University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

montelukast

Fluticasone

Arm Description

luekotriene inhibitor

Nasal steroid

Outcomes

Primary Outcome Measures

Effect of nasal allergen challenges on biomarkers

Secondary Outcome Measures

Full Information

NCT ID

NCT01240889

First Posted

October 28, 2010

Last Updated

October 8, 2012

Sponsor

Creighton University

Collaborators

Roche Pharma AG

1. Study Identification

Unique Protocol Identification Number

NCT01240889

Brief Title

Effects of Intranasal Corticosteroid and Montelukast On Nasal Allergen Challenges*

Acronym

Roche

Official Title

Effects of Intranasal Corticosteroid and Montelukast On Nasal Allergen Challenges*

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Creighton University

Collaborators

Roche Pharma AG

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergy

Keywords

Ragweed allergies, acoustic rhinometry, nasal allergen challenge

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

montelukast

Arm Type

Active Comparator

Arm Description

luekotriene inhibitor

Arm Title

Fluticasone

Arm Type

Active Comparator

Arm Description

Nasal steroid

Intervention Type

Drug

Intervention Name(s)

Fluticasone

Intervention Description

nasal spray

Intervention Type

Drug

Intervention Name(s)

Fluticason

Intervention Description

2 sprays per day in each nostril

Primary Outcome Measure Information:

Title

Effect of nasal allergen challenges on biomarkers

Time Frame

December 2011

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas B Casale, MD

Organizational Affiliation

Creighton University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Creighton University Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18331513

Citation

Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, Zuberbier T, Baena-Cagnani CE, Canonica GW, van Weel C, Agache I, Ait-Khaled N, Bachert C, Blaiss MS, Bonini S, Boulet LP, Bousquet PJ, Camargos P, Carlsen KH, Chen Y, Custovic A, Dahl R, Demoly P, Douagui H, Durham SR, van Wijk RG, Kalayci O, Kaliner MA, Kim YY, Kowalski ML, Kuna P, Le LT, Lemiere C, Li J, Lockey RF, Mavale-Manuel S, Meltzer EO, Mohammad Y, Mullol J, Naclerio R, O'Hehir RE, Ohta K, Ouedraogo S, Palkonen S, Papadopoulos N, Passalacqua G, Pawankar R, Popov TA, Rabe KF, Rosado-Pinto J, Scadding GK, Simons FE, Toskala E, Valovirta E, van Cauwenberge P, Wang DY, Wickman M, Yawn BP, Yorgancioglu A, Yusuf OM, Zar H, Annesi-Maesano I, Bateman ED, Ben Kheder A, Boakye DA, Bouchard J, Burney P, Busse WW, Chan-Yeung M, Chavannes NH, Chuchalin A, Dolen WK, Emuzyte R, Grouse L, Humbert M, Jackson C, Johnston SL, Keith PK, Kemp JP, Klossek JM, Larenas-Linnemann D, Lipworth B, Malo JL, Marshall GD, Naspitz C, Nekam K, Niggemann B, Nizankowska-Mogilnicka E, Okamoto Y, Orru MP, Potter P, Price D, Stoloff SW, Vandenplas O, Viegi G, Williams D; World Health Organization; GA(2)LEN; AllerGen. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy. 2008 Apr;63 Suppl 86:8-160. doi: 10.1111/j.1398-9995.2007.01620.x. No abstract available.

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Effects of Intranasal Corticosteroid and Montelukast On Nasal Allergen Challenges*

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