Trial · NCT03681093

Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma

NCT03681093, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2021-01-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma. Trials, record NCT03681093. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03681093

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma
NCT number: NCT03681093
Status: Completed
Phases: Phase 3
Enrollment: 98 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Nasal Polyps
Interventions: Fevipiprant 150 mg, Fevipiprant 450 mg, Placebo
First posted: 2018-09-21
Last updated: 2021-10-11
Other registries' IDs: eudract:2018-002073-22
Results first posted: 2021-01-05

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Nasal Polyp Score at Week 16	Baseline, Week 16	Nasal Polyp Score (NPS) is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 \[no polyp\] to 4 \[large polyps\] for each nostril), with a lower score indicating smaller-sized polyps. Baseline NPS is defined as the last measurement performed on or before the date of randomization. A negative change from baseline in NPS is considered a favorable outcome.
Secondary	Change From Baseline in Nasal Congestion Score at Week 16	Baseline, Week 16	The nasal congestion score (NCS) is assessed via a questionnaire where patients are asked "Is your nose blocked?" with responses ranging from 0 = not at all, to 3=severe. Baseline NCS is defined as the last assessment performed on or before the date of randomization. A negative change from baseline in NCS is considered a favorable outcome.
Secondary	Change From Baseline in Quality of Life as Assessed by the SNOT-22 Questionnaire at Week 16	Baseline, Week 16	SNOT-22 (Sino-Nasal Outcome Test) Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been for them over the past 2 weeks on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL. Baseline SNOT-22 is defined as the last assessment performed on or before the date of randomization. A negative change from baseline in SNOT-22 is considered a favorable outcome.
Secondary	Change From Baseline in Sense of Smell as Assessed by the University of Pennsylvania Smell Identification Test (UPSIT) at Week 16	Baseline, Week 16	The UPSIT (University of Pennsylvania Smell Identification Test) is a test that measures an individual's ability to detect odors. It consists of 4 workbooks of 10 pages each. On each page there is a different "scratch and sniff" strip which is embedded with a microencapsulated odorant and a question regarding the smell detected with a four-choice option for the response. The total number of questions in UPSIT is 40. The number of correct responses regarding the smells being experienced is summed to provide a total score that ranges from 0 to 40, with a higher score indicating a better sense of smell. Baseline UPSIT is defined as the last assessment performed on or before the date of randomization. A positive change from baseline in UPSIT is considered a favorable outcome.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Nasal Polyp Score at Week 16	Baseline, Week 16	Full Analysis Set	score on scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Nasal Congestion Score at Week 16	Baseline, Week 16	Full Analysis Set	score on scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Quality of Life as Assessed by the SNOT-22 Questionnaire at Week 16	Baseline, Week 16	Full Analysis Set	score on scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Sense of Smell as Assessed by the University of Pennsylvania Smell Identification Test (UPSIT) at Week 16	Baseline, Week 16	Full Analysis Set	score on scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Nasal Polyp Score at Week 16	Fevipiprant 150 mg	0.20	Standard Error 0.224	score on scale
Change From Baseline in Nasal Polyp Score at Week 16	Fevipiprant 450 mg	-0.10	Standard Error 0.216	score on scale
Change From Baseline in Nasal Polyp Score at Week 16	Placebo	0.14	Standard Error 0.233	score on scale
Change From Baseline in Nasal Congestion Score at Week 16	Fevipiprant 150 mg	-0.15	Standard Error 0.172	score on scale
Change From Baseline in Nasal Congestion Score at Week 16	Fevipiprant 450 mg	-0.35	Standard Error 0.171	score on scale
Change From Baseline in Nasal Congestion Score at Week 16	Placebo	-0.80	Standard Error 0.181	score on scale
Change From Baseline in Quality of Life as Assessed by the SNOT-22 Questionnaire at Week 16	Fevipiprant 150 mg	-3.23	Standard Error 3.349	score on scale
Change From Baseline in Quality of Life as Assessed by the SNOT-22 Questionnaire at Week 16	Fevipiprant 450 mg	-10.61	Standard Error 3.358	score on scale
Change From Baseline in Quality of Life as Assessed by the SNOT-22 Questionnaire at Week 16	Placebo	-8.44	Standard Error 3.571	score on scale
Change From Baseline in Sense of Smell as Assessed by the University of Pennsylvania Smell Identification Test (UPSIT) at Week 16	Fevipiprant 150 mg	1.05	Standard Error 1.242	score on scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Fevipiprant 150 mg	32
Overall Study	STARTED	Fevipiprant 450 mg	34
Overall Study	STARTED	Placebo	32
Overall Study	Full Analysis Set (FAS)	Fevipiprant 150 mg	31
Overall Study	Full Analysis Set (FAS)	Fevipiprant 450 mg	32
Overall Study	Full Analysis Set (FAS)	Placebo	28
Overall Study	Safety Analysis Set (SAF)	Fevipiprant 150 mg	32
Overall Study	Safety Analysis Set (SAF)	Fevipiprant 450 mg	34
Overall Study	Safety Analysis Set (SAF)	Placebo	32
Overall Study	COMPLETED	Fevipiprant 150 mg	32

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events153

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Iron deficiency anaemia	Blood and lymphatic system disorders	Fevipiprant 150 mg	0	32
other	Iron deficiency anaemia	Blood and lymphatic system disorders	Fevipiprant 450 mg	1	34
other	Iron deficiency anaemia	Blood and lymphatic system disorders	Placebo	0	32
other	Ear pain	Ear and labyrinth disorders	Fevipiprant 150 mg	1	32
other	Ear pain	Ear and labyrinth disorders	Fevipiprant 450 mg	0	34
other	Ear pain	Ear and labyrinth disorders	Placebo	0	32
other	Tympanic membrane perforation	Ear and labyrinth disorders	Fevipiprant 150 mg	0	32
other	Tympanic membrane perforation	Ear and labyrinth disorders	Fevipiprant 450 mg	1	34
other	Tympanic membrane perforation	Ear and labyrinth disorders	Placebo	0	32
other	Conjunctival haemorrhage	Eye disorders	Fevipiprant 150 mg	0	32

1 to 10 of 153Source ClinicalTrials.gov

See all 153 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Fevipiprant 150 mg	0	32
Total, all-cause mortality	Fevipiprant 450 mg	0	34
Total, all-cause mortality	Placebo	0	32
Total, other adverse events	Fevipiprant 150 mg	17	32
Total, other adverse events	Fevipiprant 450 mg	13	34
Total, other adverse events	Placebo	11	32
Total, serious adverse events	Fevipiprant 150 mg	0	32
Total, serious adverse events	Fevipiprant 450 mg	0	34
Total, serious adverse events	Placebo	0	32

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03681093

GET https://conductscience.org/api/trials/v1/NCT03681093/events?page=2

API reference For AI assistants