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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: The 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 Summary:

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.

Sponsor: University of Chicago

Current Primary Outcome: Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period [ Time Frame: Baseline and 2 weeks ]

Original Primary Outcome: Mean daily total nasal symptom scores

Current Secondary Outcome:

• Change From Baseline in Sneezing Symptom Score Over 2 Week Randomized Treatment Period [ Time Frame: Baseline and 2 weeks ]

  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 ]

  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 ]

  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 ]

  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.

Original Secondary Outcome:

• Individual symptom scores
• Rhinitis Quality of Life Questionnaires (RQLQ)
• Patient answer to treatment evaluation question

Information By: University of Chicago

Dates:
Date Received: July 1, 2005
Date Started: July 2005
Date Completion:
Last Updated: January 27, 2014
Last Verified: January 2014