Effects of Intranasal Corticosteroid and Montelukast On Nasal Allergen Challenges*

NCT01240889 | Completed

• 1 other identifier: 10-15912
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergy

Keywords

Ragweed allergies; acoustic rhinometry; nasal allergen challenge

Outcome Measures

Primary Outcomes (1)

• Effect of nasal allergen challenges on biomarkers

  December 2011

Study Arms (2)

montelukast

ACTIVE COMPARATOR

luekotriene inhibitor

Drug: Fluticasone

Fluticasone

ACTIVE COMPARATOR

Nasal steroid

Drug: Fluticason

Interventions

Fluticasone DRUG

nasal spray

montelukast

Fluticason DRUG

2 sprays per day in each nostril

Fluticasone

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Creighton University: lead
• Roche Pharma AG: collaborator

Study Sites (1)

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

Related Publications (1)

• 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.

  PMID: 18331513 BACKGROUND

MeSH Terms

Conditions

Hypersensitivity

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Thomas B Casale, MD

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 15, 2010
• Study Start: November 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 10, 2012

Record last verified: 2012-10

Locations

US (1)