A Phase 3 interventional study of Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) and Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray in Rhinitis, Allergic, Seasonal, sponsored by Sandoz. Completed at 8 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2021-02-03.
Sponsored by Sandoz · Phase 3, Interventional, and Treatment
This study compared the efficacy and safety of a generic mometasone nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal spray.
The study was designed as a double-blind, randomized, placebo-controlled, parallel group, multi-site to compare the clinical equivalence of the test formulation of mometasone furoate monohydrate, 50 mcg/actuation nasal spray (Lek Pharmaceuticals d.d.) with the reference formulation Nasonex® nasal spray (Schering) in the relief of the signs and symptoms of seasonal allergic rhinitis. 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) for 14 days of treatment. In all treatment groups, participants were instructed to administer the study drug once daily at approximately the same time each day. A single dose of 200 mcg was 4 actuations, each containing 50 mcg per actuation. Patients were instructed to administer the 4 actuations alternating between right and left nostril, such that 2 actuations were not administered back to back to the same nostril.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 795 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
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Exclusion Criteria:
Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
Drug: Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals)
Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
Drug: Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray
Placebo nasal spray administered once daily for 14 days.
Drug: Placebo
Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.
Placebo nasal spray administered once daily (4 actuations) for 14 days.
Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Equivalence: Per-Protocol Population)
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.
Time frame: Baseline, 14 days
Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Superiority: Intent-to-Treat Population)
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.
Time frame: Baseline, 14 days
Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Equivalence: Per-Protocol Population)
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.
Time frame: Baseline, 14 days
Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Superiority: Intent-to-Treat Population)
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.
Time frame: Baseline, 14 days
Clinical Global Improvement Based on the Investigator's Assessment
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.
Time frame: Day 15
Clinical Global Improvement Based on the Patient's Assessment
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.
Time frame: Day 15
Participants took part in 10 investigative sites in 1 country.
| Milestone | Test | Reference | Placebo |
|---|---|---|---|
| Started | 317 | 320 | 158 |
| Per-protocol (ppp) population | 306 | 307 | 150 |
| Intent-to-treat (itt) population | 314 | 314 | 156 |
| Completed | 314 | 314 | 154 |
| Not completed | 3 | 6 | 4 |
| Withdrew: Lost to follow up | 1 | 1 | 0 |
| Withdrew: Restricted medication for seasonal allergic rhinitis | 0 | 0 | 1 |
| Withdrew: Withdrew consent | 0 | 0 | 1 |
| Withdrew: Adverse event | 2 | 2 | 1 |
| Withdrew: Enrolled in error | 0 | 1 | 1 |
| Withdrew: Other | 0 | 2 | 0 |
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.
| score on scale | Test | Reference |
|---|---|---|
| Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Equivalence: Per-Protocol Population) | 1.981 ± 2.335 | 1.817 ± 2.258 |
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.
| score on scale | Test | Reference | Placebo |
|---|---|---|---|
| Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Superiority: Intent-to-Treat Population) | 2.008 ± 2.356 | 1.794 ± 2.257 | 1.034 ± 1.894 |
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.
| score on scale | Test | Reference |
|---|---|---|
| Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Equivalence: Per-Protocol Population) | 1.900 ± 2.408 | 1.656 ± 2.207 |
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.
| score on scale | Test | Reference | Placebo |
|---|---|---|---|
| Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Superiority: Intent-to-Treat Population) | 1.932 ± 2.419 | 1.630 ± 2.214 | 0.905 ± 1.914 |
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.
| Participants | Test | Reference | Placebo |
|---|---|---|---|
| No Relief | 34 | 53 | 39 |
| Slight Relief | 83 | 72 | 38 |
| Moderate Relief | 125 | 119 | 56 |
| Marked Relief | 68 | 67 | 23 |
| Complete Relief | 4 | 3 | 0 |
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.
| Participants | Test | Reference | Placebo |
|---|---|---|---|
| No Relief | 33 | 36 | 27 |
| Slight Relief | 83 | 83 | 46 |
| Moderate Relief | 115 | 111 | 58 |
| Marked Relief | 71 | 73 | 24 |
| Complete Relief | 12 | 11 | 1 |
Collected over From first dose of randomized treatment until last dose plus 1-4 days (up to Day 15 + 3).. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test | 0/317 (0%) | 0/317 (0%) | 5/317 (1.6%) |
| Reference | 0/320 (0%) | 0/320 (0%) | 5/320 (1.6%) |
| Placebo | 0/158 (0%) | 0/158 (0%) | 5/158 (3.2%) |
| Event | Test | Reference | Placebo |
|---|---|---|---|
| HeadacheNervous system disorders | 5/317 | 5/320 | 5/158 |
| Age, Customized(Participants) | Test | Reference | Placebo | Total |
|---|---|---|---|---|
| < 18 | 28 | 39 | 12 | 79 |
| 18 - 40 | 147 | 139 | 77 | 363 |
| 41 - 64 | 130 | 125 | 63 | 318 |
| 65 - 75 | 9 | 16 | 5 | 30 |
| > 75 | 3 | 1 | 1 | 5 |
| Sex: Female, Male(Participants) | Test | Reference | Placebo | Total |
|---|---|---|---|---|
| Female | 205 | 207 | 109 | 521 |
| Male | 112 | 113 | 49 | 274 |
| Race/Ethnicity, Customized(Participants) | Test | Reference | Placebo | Total |
|---|---|---|---|---|
| White | 271 | 277 | 140 | 688 |
| Black/African American | 39 | 35 | 15 | 89 |
| Asian | 4 | 2 | 1 | 7 |
| Native Hawaiian / Other Pacific Islander | 1 | 1 | 1 | 3 |
| Other | 2 | 5 | 1 | 8 |
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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