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
  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
Drug: Fluticasone propionate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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.



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.



Enrollment: 102
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
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

Drug: Placebo Drug: Fluticasone propionate
Other Name: flonase
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

Drug: Montelukast
Other Name: singulair
Drug: Fluticasone propionate
Other Name: flonase

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Sharp & Dohme Corp.
Investigators
Principal Investigator: Robert M Naclerio, MD University of Chicago
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00119015     History of Changes
Other Study ID Numbers: 13875B, SING-US-60-04
Study First Received: July 1, 2005
Results First Received: December 20, 2012
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
perennial allergic rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Montelukast
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 22, 2014