Trial Outcomes & Findings for A Study Comparing the Clinical Equivalence of Two Mometasone Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis (NCT NCT01038427)
NCT ID: NCT01038427
Last Updated: 2021-02-03
Results Overview
Patients were required to record a 12 hour "reflective" score twice a day approximately 12 hours apart. For the rTNSS patients were asked to "look back" or "reflect" on their severity of nasal symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms. Mean baseline rTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period. Mean change from baseline was calculated as "mean baseline rTNSS" - "mean post-randomization rTNSS". A positive change from baseline in rTNSS is considered a favorable outcome.
COMPLETED
PHASE3
795 participants
Baseline, 14 days
2021-02-03
Participant Flow
Participants took part in 10 investigative sites in 1 country.
Participants who met the inclusion/exclusion criteria entered a 7-day placebo lead-in period. Following this placebo lead-in period, on Day 1 participants who continued to meet eligibility criteria were randomly assigned in a 2:2:1 ratio to one of three treatment groups (Test Product:Reference Product:Placebo).
Participant milestones
| Measure |
Test
Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
|
Reference
Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
|
Placebo
Placebo nasal spray administered once daily for 14 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
317
|
320
|
158
|
|
Overall Study
Per-Protocol (PPP) Population
|
306
|
307
|
150
|
|
Overall Study
Intent-to-Treat (ITT) Population
|
314
|
314
|
156
|
|
Overall Study
COMPLETED
|
314
|
314
|
154
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
4
|
Reasons for withdrawal
| Measure |
Test
Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
|
Reference
Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
|
Placebo
Placebo nasal spray administered once daily for 14 days.
|
|---|---|---|---|
|
Overall Study
Lost to follow up
|
1
|
1
|
0
|
|
Overall Study
Restricted medication for seasonal allergic rhinitis
|
0
|
0
|
1
|
|
Overall Study
Withdrew consent
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
2
|
2
|
1
|
|
Overall Study
Enrolled in error
|
0
|
1
|
1
|
|
Overall Study
Other
|
0
|
2
|
0
|
Baseline Characteristics
A Study Comparing the Clinical Equivalence of Two Mometasone Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
Baseline characteristics by cohort
| Measure |
Test
n=317 Participants
Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
|
Reference
n=320 Participants
Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
|
Placebo
n=158 Participants
Placebo nasal spray administered once daily for 14 days.
|
Total
n=795 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
< 18
|
28 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Age, Customized
18 - 40
|
147 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
363 Participants
n=4 Participants
|
|
Age, Customized
41 - 64
|
130 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
318 Participants
n=4 Participants
|
|
Age, Customized
65 - 75
|
9 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Age, Customized
> 75
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
205 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
521 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
274 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
271 Participants
n=5 Participants
|
277 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
688 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
39 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian / Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 14 daysPopulation: Per-Protocol population was used in this analysis. To determine equivalence, only the test and reference treatment arms were analyzed.
Patients were required to record a 12 hour "reflective" score twice a day approximately 12 hours apart. For the rTNSS patients were asked to "look back" or "reflect" on their severity of nasal symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms. Mean baseline rTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period. Mean change from baseline was calculated as "mean baseline rTNSS" - "mean post-randomization rTNSS". A positive change from baseline in rTNSS is considered a favorable outcome.
Outcome measures
| Measure |
Test
n=306 Participants
Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
|
Reference
n=307 Participants
Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
|
Placebo
Placebo nasal spray administered once daily for 14 days.
|
|---|---|---|---|
|
Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Equivalence: Per-Protocol Population)
|
1.981 score on scale
Standard Deviation 2.335
|
1.817 score on scale
Standard Deviation 2.258
|
—
|
PRIMARY outcome
Timeframe: Baseline, 14 daysPopulation: Intent-to-Treat Population including participants with valid measurements for the outcome measure.
Patients were required to record a 12 hour "reflective" score twice a day approximately 12 hours apart. For the rTNSS patients were asked to "look back" or "reflect" on their severity of nasal symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms. Mean baseline rTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period. Mean change from baseline was calculated as "mean baseline rTNSS" - "mean post-randomization rTNSS". A positive change from baseline in rTNSS is considered a favorable outcome.
Outcome measures
| Measure |
Test
n=311 Participants
Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
|
Reference
n=311 Participants
Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
|
Placebo
n=153 Participants
Placebo nasal spray administered once daily for 14 days.
|
|---|---|---|---|
|
Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Superiority: Intent-to-Treat Population)
|
2.008 score on scale
Standard Deviation 2.356
|
1.794 score on scale
Standard Deviation 2.257
|
1.034 score on scale
Standard Deviation 1.894
|
SECONDARY outcome
Timeframe: Baseline, 14 daysPopulation: Per-Protocol population was used in this analysis. To determine equivalence, only the test and reference treatment arms were analyzed.
Patients were required to record an "instantaneous" score twice a day approximately 12 hours apart. For the iTNSS patients were asked to evaluate "how I feel now" regarding their severity of nasal symptoms. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean iTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms. Mean baseline iTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period. Mean change from baseline was calculated as "mean baseline iTNSS" - "mean post-randomization iTNSS". A positive change from baseline in iTNSS is considered a favorable outcome.
Outcome measures
| Measure |
Test
n=306 Participants
Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
|
Reference
n=307 Participants
Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
|
Placebo
Placebo nasal spray administered once daily for 14 days.
|
|---|---|---|---|
|
Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Equivalence: Per-Protocol Population)
|
1.900 score on scale
Standard Deviation 2.408
|
1.656 score on scale
Standard Deviation 2.207
|
—
|
SECONDARY outcome
Timeframe: Baseline, 14 daysPopulation: Intent-to-Treat Population including participants with valid measurements for the outcome measure.
Patients were required to record an "instantaneous" score twice a day approximately 12 hours apart. For the iTNSS patients were asked to evaluate "how I feel now" regarding their severity of nasal symptoms. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean iTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms. Mean baseline iTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period. Mean change from baseline was calculated as "mean baseline iTNSS" - "mean post-randomization iTNSS". A positive change from baseline in iTNSS is considered a favorable outcome.
Outcome measures
| Measure |
Test
n=311 Participants
Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
|
Reference
n=311 Participants
Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
|
Placebo
n=153 Participants
Placebo nasal spray administered once daily for 14 days.
|
|---|---|---|---|
|
Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Superiority: Intent-to-Treat Population)
|
1.932 score on scale
Standard Deviation 2.419
|
1.630 score on scale
Standard Deviation 2.214
|
0.905 score on scale
Standard Deviation 1.914
|
SECONDARY outcome
Timeframe: Day 15Population: Intent-to-Treat Population
A global evaluation of efficacy relative to baseline was assessed separately by the investigator and the patient on Day 15. Both the investigator and the patient were asked to rate clinical improvement since baseline on a 5-category scale ranging from "No Relief" to "Complete Relief" of signs and symptoms of seasonal allergic rhinitis. This record shows the clinical global improvement based on the investigator's assessment.
Outcome measures
| Measure |
Test
n=314 Participants
Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
|
Reference
n=314 Participants
Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
|
Placebo
n=156 Participants
Placebo nasal spray administered once daily for 14 days.
|
|---|---|---|---|
|
Clinical Global Improvement Based on the Investigator's Assessment
No Relief
|
34 Participants
|
53 Participants
|
39 Participants
|
|
Clinical Global Improvement Based on the Investigator's Assessment
Slight Relief
|
83 Participants
|
72 Participants
|
38 Participants
|
|
Clinical Global Improvement Based on the Investigator's Assessment
Moderate Relief
|
125 Participants
|
119 Participants
|
56 Participants
|
|
Clinical Global Improvement Based on the Investigator's Assessment
Marked Relief
|
68 Participants
|
67 Participants
|
23 Participants
|
|
Clinical Global Improvement Based on the Investigator's Assessment
Complete Relief
|
4 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 15Population: Intent-to-Treat Population
A global evaluation of efficacy relative to baseline was assessed separately by the investigator and the patient on Day 15. Both the investigator and the patient were asked to rate clinical improvement since baseline on a 5-category scale ranging from "No Relief" to "Complete Relief" of signs and symptoms of seasonal allergic rhinitis. This record shows the clinical global improvement based on the patient's assessment.
Outcome measures
| Measure |
Test
n=314 Participants
Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
|
Reference
n=314 Participants
Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
|
Placebo
n=156 Participants
Placebo nasal spray administered once daily for 14 days.
|
|---|---|---|---|
|
Clinical Global Improvement Based on the Patient's Assessment
No Relief
|
33 Participants
|
36 Participants
|
27 Participants
|
|
Clinical Global Improvement Based on the Patient's Assessment
Slight Relief
|
83 Participants
|
83 Participants
|
46 Participants
|
|
Clinical Global Improvement Based on the Patient's Assessment
Moderate Relief
|
115 Participants
|
111 Participants
|
58 Participants
|
|
Clinical Global Improvement Based on the Patient's Assessment
Marked Relief
|
71 Participants
|
73 Participants
|
24 Participants
|
|
Clinical Global Improvement Based on the Patient's Assessment
Complete Relief
|
12 Participants
|
11 Participants
|
1 Participants
|
Adverse Events
Test
Reference
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test
n=317 participants at risk
Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
|
Reference
n=320 participants at risk
Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
|
Placebo
n=158 participants at risk
Placebo nasal spray administered once daily for 14 days.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
1.6%
5/317 • From first dose of randomized treatment until last dose plus 1-4 days (up to Day 15 + 3).
Any signs or symptoms that occurs during randomized treatment period plus the 1-4 days post treatment.
|
1.6%
5/320 • From first dose of randomized treatment until last dose plus 1-4 days (up to Day 15 + 3).
Any signs or symptoms that occurs during randomized treatment period plus the 1-4 days post treatment.
|
3.2%
5/158 • From first dose of randomized treatment until last dose plus 1-4 days (up to Day 15 + 3).
Any signs or symptoms that occurs during randomized treatment period plus the 1-4 days post treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER