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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00119015

Enrollment

102

Registered

2005-07-12

Start date

2005-07-31

Completion date

2009-01-31

Last updated

2014-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis, Allergic, Perennial

Keywords

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.

Interventions

DRUGPlacebo

DRUGMontelukast

DRUGFluticasone propionate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period	Baseline and 2 weeks	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

Measure	Time frame	Description
Change From Baseline in Sneezing Symptom Score Over 2 Week Randomized Treatment Period	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	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	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	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.

Countries

United States

Participant flow

Recruitment details

Subjects were seen at the Nasal Physiology Laboratory at the University of Chicago.

Pre-assignment details

Those having residual symptoms (total nasal symptom score of 4+) after the open-label phase were randomized to montelukast or placebo for another two weeks in addition to fluticasone propionate. Of the 102 subjects in open-label phase, 54 with residual symptoms were randomized and are listed as completed in open-label period of participant flow.

Participants by arm

Arm	Count
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	28
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	26
Total	54

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Open-Label Phase (2 Weeks)	Did not have residual symptoms	48	0	0

Baseline characteristics

Characteristic	Fluticasone Propionate + Placebo	Fluticasone Propionate + Montelukast	Total
Age, Continuous	32 years	35 years	34 years
Race/Ethnicity, Customized Black or African American	11 participants	16 participants	27 participants
Race/Ethnicity, Customized Hispanic	2 participants	1 participants	3 participants
Race/Ethnicity, Customized White	13 participants	11 participants	24 participants
Region of Enrollment United States	26 participants	28 participants	54 participants
Sex: Female, Male Female	15 Participants	20 Participants	35 Participants
Sex: Female, Male Male	11 Participants	8 Participants	19 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 28	0 / 26
serious Total, serious adverse events	0 / 28	0 / 26

Outcome results

Primary

Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period

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.