The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis - Full Text View

Sponsors and Collaborators:	University of Chicago Merck
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00119015

Purpose

Some people with nasal allergy symptoms continue to have symptoms even after treatment with a nasal steroid spray. The purpose of this study is to see if these patients are helped by adding another medication (montelukast) to their treatment compared to placebo (a substance that looks like the active medication but does not contain the drug).

Condition	Intervention	Phase
Rhinitis, Allergic, Perennial	Drug: placebo Drug: montelukast	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis

Resource links provided by NLM:

Drug Information available for: Fluticasone propionate Fluticasone Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

Mean daily total nasal symptom scores [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Individual symptom scores [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Patient answer to treatment evaluation question [ Time Frame: at end of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	July 2005
Study Completion Date:	January 2009
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Placebo Comparator	Drug: placebo 1 tablet daily in the morning
1: Active Comparator montelukast 10 mg po daily	Drug: montelukast 10 mg po daily

Detailed Description:

Clinicians frequently prescribe an oral H1 antihistamine for allergic rhinitis patients with residual symptoms after taking an intranasal steroid. Surprisingly, the only studies investigating this combination of drugs have failed to show added efficacy of the H1 receptor over the intranasal steroids alone. Adding montelukast, a leukotriene receptor antagonist, to an intranasal steroid has not been studied in a placebo controlled fashion.

Wilson and colleagues, in an open study of patients with chronic rhinosinusitis, showed a benefit of adding montelukast.

The investigators would like to recruit perennially allergic subjects and place them on fluticasone for 2 weeks. Those subjects with residual symptoms would then be randomized to receive either placebo or montelukast in addition to continuing the fluticasone for an additional 2 weeks.

A positive study would support clinical practice and would serve as a preemptive strike against managed care plans that would not allow prescriptions for both drugs.

Hypothesis:

The addition of montelukast to treatment of a perennially allergic subject with an intranasal steroid is no more effective at relieving symptoms than a placebo.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A clinical history of perennial allergic rhinitis and a positive skin prick test to dust mite, cockroach, mold, or cat or dog antigens.
Willingness of the subject to participate in and complete the study, and the ability to understand the purpose of the trial.

Exclusion Criteria:

Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
Women of childbearing potential who are pregnant, trying to become pregnant or nursing a child.
Subjects treated with systemic steroids during the previous 30 days.
Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 15 days.
Subjects treated with oral antihistamines/decongestants during the previous seven days.
Subjects treated with topical (intranasal or intraocular) antihistamines/decongestants during the previous 3 days.
Subjects treated with immunotherapy who are escalating their dose.
Subjects on chronic anti-asthma medications.
Subjects with polyps in the nose or a significantly displaced septum.
Subjects who have incurred an upper respiratory tract infection within 14 days of the start of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00119015

Locations

United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Merck

Investigators

Principal Investigator:

Robert M Naclerio, MD

University of Chicago

More Information

Publications:

Wilson AM, White PS, Gardiner Q, Nassif R, Lipworth BJ. Effects of leukotriene receptor antagonist therapy in patients with chronic rhinosinusitis in a real life rhinology clinic setting. Rhinology. 2001 Sep;39(3):142-6.

Kurowski M, Kuna P, Gorski P. Montelukast plus cetirizine in the prophylactic treatment of seasonal allergic rhinitis: influence on clinical symptoms and nasal allergic inflammation. Allergy. 2004 Mar;59(3):280-8.

van Adelsberg J, Philip G, Pedinoff AJ, Meltzer EO, Ratner PH, Menten J, Reiss TF; Montelukast Fall Rhinitis Study Group. Montelukast improves symptoms of seasonal allergic rhinitis over a 4-week treatment period. Allergy. 2003 Dec;58(12):1268-76. Erratum in: Allergy. 2004 Mar;59(3):357.

Philip G, Nayak AS, Berger WE, Leynadier F, Vrijens F, Dass SB, Reiss TF. The effect of montelukast on rhinitis symptoms in patients with asthma and seasonal allergic rhinitis. Curr Med Res Opin. 2004 Oct;20(10):1549-58.

Di Lorenzo G, Pacor ML, Pellitteri ME, Morici G, Di Gregoli A, Lo Bianco C, Ditta V, Martinelli N, Candore G, Mansueto P, Rini GB, Corrocher R, Caruso C. Randomized placebo-controlled trial comparing fluticasone aqueous nasal spray in mono-therapy, fluticasone plus cetirizine, fluticasone plus montelukast and cetirizine plus montelukast for seasonal allergic rhinitis. Clin Exp Allergy. 2004 Feb;34(2):259-67. Erratum in: Clin Exp Allergy. 2004 Aug;34(8):1329.

Ciprandi G, Tosca MA, Milanese M, Schenone G, Ricca V. Antihistamines added to an antileukotriene in treating seasonal allergic rhinitis: histamine and leukotriene antagonism. Allerg Immunol (Paris). 2004 Feb;36(2):67-70, 72.

Chervinsky P, Philip G, Malice MP, Bardelas J, Nayak A, Marchal JL, van Adelsberg J, Bousquet J, Tozzi CA, Reiss TF. Montelukast for treating fall allergic rhinitis: effect of pollen exposure in 3 studies. Ann Allergy Asthma Immunol. 2004 Mar;92(3):367-73.

Moinuddin R, deTineo M, Maleckar B, Naclerio RM, Baroody FM. Comparison of the combinations of fexofenadine-pseudoephedrine and loratadine-montelukast in the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2004 Jan;92(1):73-9.

Topuz B, Ogmen GG. Montelukast as an adjuvant to mainstay therapies in patients with seasonal allergic rhinitis. Clin Exp Allergy. 2003 Jun;33(6):823-6.

Ratner PH, Howland WC 3rd, Arastu R, Philpot EE, Klein KC, Baidoo CA, Faris MA, Rickard KA. Fluticasone propionate aqueous nasal spray provided significantly greater improvement in daytime and nighttime nasal symptoms of seasonal allergic rhinitis compared with montelukast. Ann Allergy Asthma Immunol. 2003 May;90(5):536-42.

Saengpanich S, deTineo M, Naclerio RM, Baroody FM. Fluticasone nasal spray and the combination of loratadine and montelukast in seasonal allergic rhinitis. Arch Otolaryngol Head Neck Surg. 2003 May;129(5):557-62.

Baena-Cagnani CE, Berger WE, DuBuske LM, Gurne SE, Stryszak P, Lorber R, Danzig M. Comparative effects of desloratadine versus montelukast on asthma symptoms and use of beta 2-agonists in patients with seasonal allergic rhinitis and asthma. Int Arch Allergy Immunol. 2003 Apr;130(4):307-13.

van Adelsberg J, Philip G, LaForce CF, Weinstein SF, Menten J, Malice MP, Reiss TF; Montelukast Spring Rhinitis Investigator Group. Randomized controlled trial evaluating the clinical benefit of montelukast for treating spring seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2003 Feb;90(2):214-22.

Philip G, Malmstrom K, Hampel FC, Weinstein SF, LaForce CF, Ratner PH, Malice MP, Reiss TF; Montelukast Spring Rhinitis Study Group. Montelukast for treating seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial performed in the spring. Clin Exp Allergy. 2002 Jul;32(7):1020-8.

Nayak AS, Philip G, Lu S, Malice MP, Reiss TF; Montelukast Fall Rhinitis Investigator Group. Efficacy and tolerability of montelukast alone or in combination with loratadine in seasonal allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled trial performed in the fall. Ann Allergy Asthma Immunol. 2002 Jun;88(6):592-600.

Pullerits T, Praks L, Ristioja V, Lotvall J. Comparison of a nasal glucocorticoid, antileukotriene, and a combination of antileukotriene and antihistamine in the treatment of seasonal allergic rhinitis. J Allergy Clin Immunol. 2002 Jun;109(6):949-55.

Wilson AM, Sims EJ, Orr LC, Coutie WJ, White PS, Gardiner Q, Lipworth BJ. Effects of topical corticosteroid and combined mediator blockade on domiciliary and laboratory measurements of nasal function in seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2001 Oct;87(4):344-9.

Wilson AM, Dempsey OJ, Sims EJ, Lipworth BJ. A comparison of topical budesonide and oral montelukast in seasonal allergic rhinitis and asthma. Clin Exp Allergy. 2001 Apr;31(4):616-24.

Wilson AM, Orr LC, Sims EJ, Lipworth BJ. Effects of monotherapy with intra-nasal corticosteroid or combined oral histamine and leukotriene receptor antagonists in seasonal allergic rhinitis. Clin Exp Allergy. 2001 Jan;31(1):61-8.

Wilson AM, Orr LC, Sims EJ, Dempsey OJ, Lipworth BJ. Antiasthmatic effects of mediator blockade versus topical corticosteroids in allergic rhinitis and asthma. Am J Respir Crit Care Med. 2000 Oct;162(4 Pt 1):1297-301.

Responsible Party:	University ofChicago ( Robert Naclerio, MD )
Study ID Numbers:	13875B, SING-US-60-04
Study First Received:	July 1, 2005
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00119015 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

perennial allergic rhinitis

Study placed in the following topic categories:

Anti-Inflammatory Agents
Otorhinolaryngologic Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Rhinitis
Anti-Allergic Agents
Hormones
Leukotriene Antagonists
Montelukast

Hypersensitivity
Rhinitis, Allergic, Perennial
Respiratory Tract Diseases
Respiratory Tract Infections
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Rhinitis
Leukotriene Antagonists
Hypersensitivity
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis, Allergic, Perennial
Therapeutic Uses
Fluticasone

Dermatologic Agents
Otorhinolaryngologic Diseases
Immune System Diseases
Anti-Asthmatic Agents
Anti-Allergic Agents
Nose Diseases
Pharmacologic Actions
Montelukast
Autonomic Agents
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 09, 2009