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

This study has been terminated.
(Difficulty in recruitment)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00119015
First received: July 1, 2005
Last updated: January 27, 2014
Last verified: January 2014

July 1, 2005
January 27, 2014
July 2005
June 2008   (final data collection date for primary outcome measure)
Change 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.

Mean daily total nasal symptom scores
Complete list of historical versions of study NCT00119015 on ClinicalTrials.gov Archive Site
  • 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.

  • Individual symptom scores
  • Rhinitis Quality of Life Questionnaires (RQLQ)
  • Patient answer to treatment evaluation question
Not Provided
Not Provided
 
The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis
The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis

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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Rhinitis, Allergic, Perennial
  • Drug: Placebo
  • Drug: Montelukast
    Other Name: singulair
  • Drug: Fluticasone propionate
    Other Name: flonase
  • 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

    Interventions:
    • Drug: Placebo
    • Drug: Fluticasone propionate
  • 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

    Interventions:
    • Drug: Montelukast
    • Drug: Fluticasone propionate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
102
January 2009
June 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00119015
13875B, SING-US-60-04
No
University of Chicago
University of Chicago
Merck Sharp & Dohme Corp.
Principal Investigator: Robert M Naclerio, MD University of Chicago
University of Chicago
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP