The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis

Overview[ - collapse ][ - ]

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).
ConditionRhinitis, Allergic, Perennial
InterventionDrug: Placebo
Drug: Montelukast
Drug: Fluticasone propionate
PhasePhase 4
SponsorUniversity of Chicago
Responsible PartyUniversity of Chicago
ClinicalTrials.gov IdentifierNCT00119015
First ReceivedJuly 1, 2005
Last UpdatedJanuary 27, 2014
Last verifiedJanuary 2014

Tracking Information[ + expand ][ + ]

First Received DateJuly 1, 2005
Last Updated DateJanuary 27, 2014
Start DateJuly 2005
Estimated Primary Completion DateJanuary 2009
Current Primary Outcome MeasuresChange From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period [Time Frame: Baseline and 2 weeks] [Designated as safety issue: No]Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (itchy nose/eyes and post-nasal drip) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24.
The baseline TNSS used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.
The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.
A negative value indicates an improvement in symptoms.
Current Secondary Outcome Measures
  • Change From Baseline in Sneezing Symptom Score Over 2 Week Randomized Treatment Period [Time Frame: Baseline and 2 weeks] [Designated as safety issue: No]Patients recorded the severity of sneezing twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The sneezing symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.
    The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.
    The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.
    A negative value indicates an improvement in symptoms.
  • Change From Baseline in Runny Nose Symptom Score Over 2 Week Randomized Treatment Period [Time Frame: Baseline and 2 weeks] [Designated as safety issue: No]Patients recorded the severity of runny nose twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The runny nose symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.
    The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.
    The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.
    A negative value indicates an improvement in symptoms.
  • Change From Baseline in Stuffy Nose Symptom Score Over 2 Week Randomized Treatment Period [Time Frame: Baseline and 2 weeks] [Designated as safety issue: No]Patients recorded the severity of stuffy nose twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The stuffy nose symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.
    The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.
    The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.
    A negative value indicates an improvement in symptoms.
  • Change From Baseline in Other Symptom Score Over 2 Week Randomized Treatment Period [Time Frame: Baseline and 2 weeks] [Designated as safety issue: No]Patients recorded the severity of other symptoms, including itchy nose/eyes and post-nasal drip, twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The other symptom score was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 6.
    The baseline symptom score used in the analysis was the average of the symptom scores from the last 5 days of fluticasone propionate therapy prior to randomized treatment period.
    The change from baseline for each subsequent day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group.
    A negative value indicates an improvement in symptoms.

Descriptive Information[ + expand ][ + ]

Brief TitleThe Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis
Official TitleThe Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis
Brief 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).
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 more effective at relieving symptoms than a placebo.
Study TypeInterventional
Study PhasePhase 4
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
ConditionRhinitis, Allergic, Perennial
InterventionDrug: Placebo
Drug: Montelukast
Other Names:
singulairDrug: Fluticasone propionate
Other Names:
flonase
Study Arm (s)
  • Placebo Comparator: Fluticasone propionate + Placebo
    Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)
    Placebo - 10 mg po daily for 2 weeks
  • Active Comparator: Fluticasone propionate + Montelukast
    Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)
    Montelukast - 10 mg po daily for 2 weeks

Recruitment Information[ + expand ][ + ]

Recruitment StatusTerminated
Estimated Enrollment102
Estimated Completion DateJanuary 2009
Estimated Primary Completion DateJune 2008
Eligibility 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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00119015
Other Study ID Numbers13875B
Has Data Monitoring CommitteeNo
Information Provided ByUniversity of Chicago
Study SponsorUniversity of Chicago
CollaboratorsMerck Sharp & Dohme Corp.
Investigators Principal Investigator: Robert M Naclerio, MD University of Chicago
Verification DateJanuary 2014

Locations[ + expand ][ + ]

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