Clinical Trials Logo

Clinical Trial Summary

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).


Clinical Trial 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 more effective at relieving symptoms than a placebo. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00119015
Study type Interventional
Source University of Chicago
Contact
Status Terminated
Phase Phase 4
Start date July 2005
Completion date January 2009

See also
  Status Clinical Trial Phase
Completed NCT02443805 - Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR Phase 3
Completed NCT01231464 - A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Nasal Spray for 2 Weeks in Chinese Adult and Adolescent Subjects With Allergic Rhinitis Phase 3
Completed NCT00232518 - Randomised Controlled Clinical Trials of the Effect of Therapeutic Hookworm Infection in Allergic Rhinoconjunctivitis N/A
Completed NCT00224523 - Long Term Safety Of GW685698X Via Nasal Biopsy Phase 3
Completed NCT00658918 - To Assess the Safety of Ciclesonide, Applied as a Nasal Spray at Three Dose Levels, in the Treatment of Perennial Allergic Rhinitis in Pediatrics (BY9010/M1-405) Phase 3
Completed NCT00404586 - Effects Of Single Doses Of GW784568X On Allergic Rhinitis Symptoms In Male Subjects Whilst In An Environmental Chamber Phase 1
Withdrawn NCT02988778 - Clinical Study, Non Inferiority Between Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis Phase 3
Completed NCT00988247 - Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis Phase 3
Completed NCT01644617 - A Dose-Ranging Study of the Safety and Effectiveness of MK-8237 in the Treatment of House Dust Mite (HDM) Induced Allergic Rhinitis/Rhinoconjunctivitis in Adults (MK-8237-003/P07627) Phase 2
Completed NCT01678807 - Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (MK-8237-008) Phase 1
Completed NCT01216384 - Single Rising Dose (SRD), Multiple Rising Dose (MRD) Study of BI 671800 in Healthy Asian Volunteers Phase 1
Completed NCT00848965 - A Randomised, Double Blind, Placebo Controlled, 4 Period, Incomplete Block, Crossover Study Assessing the Dose-response Curve of Fluticasone Propionate in an Antigen Challenge Chamber Phase 4
Completed NCT00092118 - The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265) Phase 3
Completed NCT00839189 - Effect of a 10,000 EU Dose of Endotoxin in Allergic and Mildly Asthmatic Adults Phase 1
Completed NCT00570492 - Phase 4 Fluticasone Furoate Nasal Spray (VERAMYST) Long Term Pediatric Growth Study. Phase 4
Completed NCT00806754 - Investigation of the Efficacy and Safety of Concomitant Administration of Ciclesonide Nasal Spray and Azelastine Nasal Spray in Patients (18 Years or Older) With Perennial Allergic Rhinitis (PAR) Not Adequately Controlled on an Intranasal Corticosteroid or Antihistamine Monotherapy (BY9010/M1-490) Phase 4
Recruiting NCT00153595 - EWO1 in Persistent Allergic Rhinitis Patients Phase 2/Phase 3
Completed NCT00132925 - An Efficacy and Safety Evaluation of Nasacort AQ in Children Ages 2-5 Years With Perennial Allergic Rhinitis Phase 3
Completed NCT02498509 - Clinical Trial to Evaluate the Efficacy and Safety of CKD-342 Phase 3
Completed NCT01134705 - Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis) Phase 3