Trial Outcomes & Findings for A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis (NCT NCT01279057)

NCT ID: NCT01279057

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 727 participants
• Primary outcome timeframe: Baseline, 14 days
• Results posted on: 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 Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Reference Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Placebo Placebo nasal spray administered once daily for 14 days.
Overall Study STARTED	288	292	147
Overall Study Per-Protocol (PPP) Population	257	245	126
Overall Study Intent-to-Treat (ITT) Population	284	285	144
Overall Study COMPLETED	282	287	144
Overall Study NOT COMPLETED	6	5	3

Reasons for withdrawal

Measure	Test Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Reference Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Placebo Placebo nasal spray administered once daily for 14 days.
Overall Study Adverse Event	1	0	1
Overall Study Insufficient therapeutic response	0	0	1
Overall Study Restricted medication for seasonal allergic rhinitis	0	1	0
Overall Study Withdrew consent	2	0	1
Overall Study Pregnancy	0	1	0
Overall Study Other	3	3	0

Baseline Characteristics

A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

Baseline characteristics by cohort

Measure	Test n=288 Participants Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Reference n=292 Participants Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Placebo n=147 Participants Placebo nasal spray administered once daily for 14 days.	Total n=727 Participants Total of all reporting groups
Age, Customized < 18	17 Participants n=93 Participants	28 Participants n=4 Participants	17 Participants n=27 Participants	62 Participants n=483 Participants
Age, Customized 18 - 40	133 Participants n=93 Participants	122 Participants n=4 Participants	65 Participants n=27 Participants	320 Participants n=483 Participants
Age, Customized 41 - 64	122 Participants n=93 Participants	137 Participants n=4 Participants	59 Participants n=27 Participants	318 Participants n=483 Participants
Age, Customized 65 - 75	15 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants	25 Participants n=483 Participants
Age, Customized > 75	1 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants
Sex: Female, Male Female	174 Participants n=93 Participants	195 Participants n=4 Participants	91 Participants n=27 Participants	460 Participants n=483 Participants
Sex: Female, Male Male	114 Participants n=93 Participants	97 Participants n=4 Participants	56 Participants n=27 Participants	267 Participants n=483 Participants
Race/Ethnicity, Customized White	233 Participants n=93 Participants	241 Participants n=4 Participants	126 Participants n=27 Participants	600 Participants n=483 Participants
Race/Ethnicity, Customized Black/African American	50 Participants n=93 Participants	40 Participants n=4 Participants	19 Participants n=27 Participants	109 Participants n=483 Participants
Race/Ethnicity, Customized Asian	2 Participants n=93 Participants	5 Participants n=4 Participants	2 Participants n=27 Participants	9 Participants n=483 Participants
Race/Ethnicity, Customized Native Hawaiian / Other Pacific Islander	0 Participants n=93 Participants	2 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants
Race/Ethnicity, Customized American Indian / Alaska Native	2 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants
Race/Ethnicity, Customized Other	1 Participants n=93 Participants	4 Participants n=4 Participants	0 Participants n=27 Participants	5 Participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline, 14 days

Population: 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=257 Participants Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Reference n=245 Participants Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Placebo Placebo nasal spray administered once daily for 14 days.
PRIMARY: Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Equivalence: Per-Protocol Population)	2.036 score on scale Standard Deviation 2.415	1.904 score on scale Standard Deviation 2.409	—

PRIMARY outcome

Timeframe: Baseline, 14 days

Population: 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=284 Participants Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Reference n=284 Participants Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Placebo n=144 Participants Placebo nasal spray administered once daily for 14 days.
PRIMARY: Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Superiority: Intent-to-Treat Population)	2.035 score on scale Standard Deviation 2.362	1.845 score on scale Standard Deviation 2.378	0.952 score on scale Standard Deviation 1.842

SECONDARY outcome

Timeframe: Baseline, 14 days

Population: Per-Protocol population was used in this analysis. To determine equivalence, only the test and reference treatment arms were analyzed.

Participants were required to record an "instantaneous" score twice a day approximately 12 hours apart. For the iTNSS participants 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. Participants 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=257 Participants Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Reference n=245 Participants Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 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)	2.017 score on scale Standard Deviation 2.439	1.854 score on scale Standard Deviation 2.411	—

SECONDARY outcome

Timeframe: Baseline, 14 days

Population: Intent-to-Treat Population including participants with valid measurements for the outcome measure.

Participants were required to record an "instantaneous" score twice a day approximately 12 hours apart. For the iTNSS participants 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. Participants 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=284 Participants Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Reference n=284 Participants Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Placebo n=144 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)	1.994 score on scale Standard Deviation 2.398	1.805 score on scale Standard Deviation 2.398	0.846 score on scale Standard Deviation 1.981

SECONDARY outcome

Timeframe: Baseline, 14 days

Population: 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 rTOSS patients were asked to "look back" or "reflect" on their severity of ocular symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 3 ocular symptoms (eye redness, itching/burning eyes, and tearing/watering eyes) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 3 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTOSS, which ranged from 0 to 9 with a lower score indicating less severe symptoms.

Mean baseline rTOSS was calculated by summing the means of the 3 individual symptom scores obtained over the 72 hours before the randomized treatment period.

Mean change from baseline was calculated as "mean baseline rTOSS" - "mean post-randomization rTOSS". A positive change from baseline is considered a favorable outcome.

Outcome measures

Measure	Test n=257 Participants Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Reference n=245 Participants Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Placebo Placebo nasal spray administered once daily for 14 days.
Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS) (Equivalence: Per-Protocol Population)	1.388 score on scale Standard Deviation 1.831	1.152 score on scale Standard Deviation 1.790	—

SECONDARY outcome

Timeframe: Baseline, 14 days

Population: 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 rTOSS patients were asked to "look back" or "reflect" on their severity of ocular symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 3 ocular symptoms (eye redness, itching/burning eyes, and tearing/watering eyes) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 3 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTOSS, which ranged from 0 to 9 with a lower score indicating less severe symptoms.

Mean baseline rTOSS was calculated by summing the means of the 3 individual symptom scores obtained over the 72 hours before the randomized treatment period.

Mean change from baseline was calculated as "mean baseline rTOSS" - "mean post-randomization rTOSS". A positive change from baseline is considered a favorable outcome.

Outcome measures

Measure	Test n=284 Participants Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Reference n=284 Participants Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Placebo n=144 Participants Placebo nasal spray administered once daily for 14 days.
Mean Change From Baseline in Reflective Total Ocular Symptom Score (rTOSS) (Superiority: Intent-to-Treat Population)	1.373 score on scale Standard Deviation 1.795	1.128 score on scale Standard Deviation 1.762	0.787 score on scale Standard Deviation 1.527

SECONDARY outcome

Timeframe: Baseline, 14 days

Population: 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 iTOSS patients were asked to evaluate "how I feel now" regarding their severity of ocular symptoms. The first rating on each day was taken prior to dosing. Patients were asked to score 3 ocular symptoms (eye redness, itching/burning eyes, and tearing/watering eyes) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 3 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTOSS, which ranged from 0 to 9 with a lower score indicating less severe symptoms.

Mean baseline rTOSS was calculated by summing the means of the 3 individual symptom scores obtained over the 72 hours before the randomized treatment period.

Mean change from baseline was calculated as "mean baseline iTOSS" - "mean post-randomization iTOSS". A positive change from baseline in iTOSS is considered a favorable outcome.

Outcome measures

Measure	Test n=257 Participants Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Reference n=245 Participants Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Placebo Placebo nasal spray administered once daily for 14 days.
Mean Change From Baseline in Instantaneous Total Ocular Symptom Score (iTOSS) (Equivalence: Per-Protocol Population)	1.389 score on scale Standard Deviation 1.884	1.135 score on scale Standard Deviation 1.803	—

SECONDARY outcome

Timeframe: Baseline, 14 days

Population: 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 iTOSS patients were asked to evaluate "how I feel now" regarding their severity of ocular symptoms. The first rating on each day was taken prior to dosing. Patients were asked to score 3 ocular symptoms (eye redness, itching/burning eyes, and tearing/watering eyes) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 3 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTOSS, which ranged from 0 to 9 with a lower score indicating less severe symptoms.

Mean baseline rTOSS was calculated by summing the means of the 3 individual symptom scores obtained over the 72 hours before the randomized treatment period.

Mean change from baseline was calculated as "mean baseline iTOSS" - "mean post-randomization iTOSS". A positive change from baseline in iTOSS is considered a favorable outcome.

Outcome measures

Measure	Test n=284 Participants Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Reference n=284 Participants Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Placebo n=144 Participants Placebo nasal spray administered once daily for 14 days.
Mean Change From Baseline in Instantaneous Total Ocular Symptom Score (iTOSS) (Superiority: Intent-to-Treat Population)	1.362 score on scale Standard Deviation 1.851	1.118 score on scale Standard Deviation 1.784	0.787 score on scale Standard Deviation 1.563

Adverse Events

Test

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Reference

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Test n=288 participants at risk Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Reference n=292 participants at risk Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Placebo n=147 participants at risk Placebo nasal spray administered once daily for 14 days.
Respiratory, thoracic and mediastinal disorders Chest pain	0.00% 0/288 • 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.	0.00% 0/292 • 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.	0.68% 1/147 • 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.

Other adverse events

Measure	Test n=288 participants at risk Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Reference n=292 participants at risk Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.	Placebo n=147 participants at risk Placebo nasal spray administered once daily for 14 days.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.1% 6/288 • 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.	1.4% 4/292 • 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.	2.7% 4/147 • 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

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: Novartis.email@novartis.com

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