Trial Outcomes & Findings for The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis (NCT NCT00119015)
NCT ID: NCT00119015
Last Updated: 2014-02-28
Results Overview
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.
TERMINATED
PHASE4
102 participants
Baseline and 2 weeks
2014-02-28
Participant Flow
Subjects were seen at the Nasal Physiology Laboratory at the University of Chicago.
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.
Participant milestones
| Measure |
Fluticasone Propionate Only
Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)
|
Fluticasone Propionate+Montelukast
Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)
Montelukast - 10 mg po daily
|
Fluticasone Propionate+Placebo
Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)
Placebo - 10 mg po daily
|
|---|---|---|---|
|
Open-Label Phase (2 Weeks)
STARTED
|
102
|
0
|
0
|
|
Open-Label Phase (2 Weeks)
COMPLETED
|
54
|
0
|
0
|
|
Open-Label Phase (2 Weeks)
NOT COMPLETED
|
48
|
0
|
0
|
|
Double-Blind, Randomized Phase (2 Weeks)
STARTED
|
0
|
28
|
26
|
|
Double-Blind, Randomized Phase (2 Weeks)
COMPLETED
|
0
|
28
|
26
|
|
Double-Blind, Randomized Phase (2 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Fluticasone Propionate Only
Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)
|
Fluticasone Propionate+Montelukast
Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)
Montelukast - 10 mg po daily
|
Fluticasone Propionate+Placebo
Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)
Placebo - 10 mg po daily
|
|---|---|---|---|
|
Open-Label Phase (2 Weeks)
Did not have residual symptoms
|
48
|
0
|
0
|
Baseline Characteristics
The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis
Baseline characteristics by cohort
| Measure |
Fluticasone Propionate + Montelukast
n=28 Participants
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
|
Fluticasone Propionate + Placebo
n=26 Participants
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
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 years
n=5 Participants
|
32 years
n=7 Participants
|
34 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
11 participants
n=5 Participants
|
13 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
16 participants
n=5 Participants
|
11 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
26 participants
n=7 Participants
|
54 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2 weeksPatients 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.
Outcome measures
| Measure |
Fluticasone Propionate + Montelukast
n=28 Participants
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
|
Fluticasone Propionate + Placebo
n=26 Participants
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
|
|---|---|---|
|
Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period
|
-1.66 units on a scale
Interval -17.85 to 1.69
|
-2.21 units on a scale
Interval -13.82 to 4.5
|
SECONDARY outcome
Timeframe: Baseline and 2 weeksPatients 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.
Outcome measures
| Measure |
Fluticasone Propionate + Montelukast
n=28 Participants
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
|
Fluticasone Propionate + Placebo
n=26 Participants
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
|
|---|---|---|
|
Change From Baseline in Sneezing Symptom Score Over 2 Week Randomized Treatment Period
|
-0.22 units on a scale
Interval -5.62 to 2.0
|
-0.25 units on a scale
Interval -2.57 to 2.68
|
SECONDARY outcome
Timeframe: Baseline and 2 weeksPatients 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.
Outcome measures
| Measure |
Fluticasone Propionate + Montelukast
n=28 Participants
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
|
Fluticasone Propionate + Placebo
n=26 Participants
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
|
|---|---|---|
|
Change From Baseline in Runny Nose Symptom Score Over 2 Week Randomized Treatment Period
|
-0.52 units on a scale
Interval -3.85 to 1.08
|
-0.29 units on a scale
Interval -2.6 to 2.42
|
SECONDARY outcome
Timeframe: Baseline and 2 weeksPatients 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.
Outcome measures
| Measure |
Fluticasone Propionate + Montelukast
n=28 Participants
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
|
Fluticasone Propionate + Placebo
n=26 Participants
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
|
|---|---|---|
|
Change From Baseline in Stuffy Nose Symptom Score Over 2 Week Randomized Treatment Period
|
-0.41 units on a scale
Interval -5.31 to 2.37
|
-0.47 units on a scale
Interval -4.53 to 2.0
|
SECONDARY outcome
Timeframe: Baseline and 2 weeksPatients 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.
Outcome measures
| Measure |
Fluticasone Propionate + Montelukast
n=28 Participants
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
|
Fluticasone Propionate + Placebo
n=26 Participants
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
|
|---|---|---|
|
Change From Baseline in Other Symptom Score Over 2 Week Randomized Treatment Period
|
-0.24 units on a scale
Interval -3.4 to 1.25
|
-0.14 units on a scale
Interval -4.35 to 1.22
|
Adverse Events
Fluticasone Propionate + Montelukast
Fluticasone Propionate + Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place