Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma - Clinical Trial for Nasal Polyps | NCT03681093

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Fevipiprant 150 mg

Fevipiprant 450 mg

Placebo

About this trial

This is an interventional treatment trial for Nasal Polyps focused on measuring Nasal Polyposis, Asthma, Nasal polyp score (NPS), Nasal congestion score (NCS), Bronchial Diseases, Lung Diseases, Nose Diseases, Respiratory Hypersensitivity, Fevipiprant, QAW039

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients aged 18 years or more with a diagnosis of nasal polyps with Nasal polyp score >= 4 with minimum score of 2 in each nostril.
Concomitant diagnosis of asthma for a period of at least 6 months prior to screening.
Patients on stable asthma treatment of at least inhaled corticosteroids (any dose) alone for at least 6 months prior to screening or ICS for 6 months prior to screening with any required, inhaled medication (LABA, LAMA) added at least 6 weeks prior to screening.

Exclusion Criteria:

Asthma exacerbation, within 6 weeks prior to screening, that required systemic corticosteroids, hospitalization or emergency room visit.
Chronic/maintenance use of oral corticosteroids (OCS) defined as any continuous use of OCS for a period of 1 month or more, within 1 year of screening
Use of biologics for asthma or any other indications, that has the potential to interfere/affect either asthma or nasal polyposis disease progression, within 6 months of screening.
Use of medication for sino-nasal symptoms (antibiotics with or without OCS) within 30 days of screening or during the run-in period.
Use of tetracycline or macrolide antibiotics specifically, within 8 weeks of screening.
History of nasal surgery modifying the structure of the nose such that assessment of the nasal polyp score is not possible.
Patients with baseline ACQ-5≥1.5

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Fevipiprant 150 mg

Fevipiprant 450 mg

Placebo

Arm Description

Fevipiprant (QAW039) 150 mg once daily orally

Fevipiprant (QAW039) 450 mg once daily orally

Placebo once daily orally

Outcomes

Primary Outcome Measures

Change From Baseline in Nasal Polyp Score at 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 Outcome Measures

Change From Baseline in Nasal Congestion Score at 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.

Change From Baseline in Quality of Life as Assessed by the SNOT-22 Questionnaire at 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.

Change From Baseline in Sense of Smell as Assessed by the University of Pennsylvania Smell Identification Test (UPSIT) at 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.

Full Information

NCT ID

NCT03681093

First Posted

September 20, 2018

Last Updated

October 7, 2021

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03681093

Brief Title

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

Acronym

THUNDER

Official Title

A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Fevipiprant Once Daily Plus Standard-of-care (SoC) for Assessment of the Efficacy in Reduction of Nasal Polyp Size in Patients With Nasal Polyposis and Concomitant Asthma.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

March 26, 2019 (Actual)

Primary Completion Date

May 29, 2020 (Actual)

Study Completion Date

June 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

A Phase 3b Proof-of-Concept study to evaluate the ability of fevipiprant 150 mg and 450 mg, compared with placebo, as add-on to nasal spray standard-of-care (SoC), in reducing endoscopic nasal polyp score in adult (≥ 18 years) patients with nasal polyposis and concomitant asthma.

Detailed Description

This was a Phase 3b, Proof-of-concept study with a randomized, multicenter, double-blind, placebo-controlled, parallel-group study design to determine the ability of fevipiprant plus standard of care (SoC) compared to placebo plus SoC to reduce the size of nasal polyps. The study enrolled adult male and female patients diagnosed with nasal polyposis with a nasal polyp score assessed by nasal endoscopy ≥ 4 at baseline with a minimum score of 2 in each nostril and a concomitant diagnosis of asthma. Patients who meet the inclusion/exclusion criteria were randomized in 1:1:1 ratio in either of the 3 arms fevipiprant 450 mg dose once daily (o.d.), fevipiprant 150 mg dose o.d. or placebo o.d. in addition to SoC (mometasone furoate spray). The study included: a Screening period of 2 weeks to assess eligibility a Run-in period of 4 weeks where patients utilized mometasone furoate spray (200 μg once daily, administered as two 50 μg actuations into each nostril) a Treatment period of 16 weeks. Patients continued to use the mometasone furoate SoC throughout the treatment period. a Follow-up period of 2 weeks following the last dose of study drug to collect additional data for safety variables. The purpose of this study was to evaluate the efficacy and safety of fevipiprant 150 mg and 450 mg compared to placebo in the reduction of nasal polyps size and the effect on symptoms, quality of life and smell via patient-reported outcomes in patients with nasal polyposis and concomitant asthma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasal Polyps

Keywords

Nasal Polyposis, Asthma, Nasal polyp score (NPS), Nasal congestion score (NCS), Bronchial Diseases, Lung Diseases, Nose Diseases, Respiratory Hypersensitivity, Fevipiprant, QAW039

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Double blind, double dummy study design.

Allocation

Randomized

Enrollment

98 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fevipiprant 150 mg

Arm Type

Experimental

Arm Description

Fevipiprant (QAW039) 150 mg once daily orally

Arm Title

Fevipiprant 450 mg

Arm Type

Experimental

Arm Description

Fevipiprant (QAW039) 450 mg once daily orally

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo once daily orally

Intervention Type

Drug

Intervention Name(s)

Fevipiprant 150 mg

Intervention Description

Fevipiprant (QAW039) 150 mg once daily administered orally as tablet

Intervention Type

Drug

Intervention Name(s)

Fevipiprant 450 mg

Intervention Description

Fevipiprant (QAW039) 450 mg once daily administered orally as tablet

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo once daily administered orally as tablet

Primary Outcome Measure Information:

Title

Change From Baseline in Nasal Polyp Score at Week 16

Description

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.

Time Frame

Baseline, Week 16

Secondary Outcome Measure Information:

Title

Change From Baseline in Nasal Congestion Score at Week 16

Description

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.

Time Frame

Baseline, Week 16

Title

Change From Baseline in Quality of Life as Assessed by the SNOT-22 Questionnaire at Week 16

Description

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.

Time Frame

Baseline, Week 16

Title

Change From Baseline in Sense of Smell as Assessed by the University of Pennsylvania Smell Identification Test (UPSIT) at Week 16

Description

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.

Time Frame

Baseline, Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Patients aged 18 years or more with a diagnosis of nasal polyps with Nasal polyp score >= 4 with minimum score of 2 in each nostril. Concomitant diagnosis of asthma for a period of at least 6 months prior to screening. Patients on stable asthma treatment of at least inhaled corticosteroids (any dose) alone for at least 6 months prior to screening or ICS for 6 months prior to screening with any required, inhaled medication (LABA, LAMA) added at least 6 weeks prior to screening. Exclusion Criteria: Asthma exacerbation, within 6 weeks prior to screening, that required systemic corticosteroids, hospitalization or emergency room visit. Chronic/maintenance use of oral corticosteroids (OCS) defined as any continuous use of OCS for a period of 1 month or more, within 1 year of screening Use of biologics for asthma or any other indications, that has the potential to interfere/affect either asthma or nasal polyposis disease progression, within 6 months of screening. Use of medication for sino-nasal symptoms (antibiotics with or without OCS) within 30 days of screening or during the run-in period. Use of tetracycline or macrolide antibiotics specifically, within 8 weeks of screening. History of nasal surgery modifying the structure of the nose such that assessment of the nasal polyp score is not possible. Patients with baseline ACQ-5≥1.5

Facility Information:

Facility Name

Novartis Investigative Site

City

Irvine

State/Province

California

ZIP/Postal Code

92618

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1414AIF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1425BEN

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1426ABP

Country

Argentina

Facility Name

Novartis Investigative Site

City

Florida

State/Province

Buenos Aires

ZIP/Postal Code

B1602DQD

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000DBS

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1125ABE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Erpent

ZIP/Postal Code

5100

Country

Belgium

Facility Name

Novartis Investigative Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1G 6C6

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G1V 4W2

Country

Canada

Facility Name

Novartis Investigative Site

City

Olomouc

State/Province

Czech Republic

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Svitavy

State/Province

Czech Republic

ZIP/Postal Code

568 25

Country

Czechia

Facility Name

Novartis Investigative Site

City

Kladno

ZIP/Postal Code

27259

Country

Czechia

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Novartis Investigative Site

City

Rozzano

State/Province

MI

ZIP/Postal Code

20089

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

State/Province

PI

ZIP/Postal Code

56124

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

RM

ZIP/Postal Code

00168

Country

Italy

Facility Name

Novartis Investigative Site

City

Amsterdam

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Enschede

ZIP/Postal Code

7511 JH

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Strzelce Opolskie

ZIP/Postal Code

47 100

Country

Poland

Facility Name

Novartis Investigative Site

City

Zawadzkie

ZIP/Postal Code

47-120

Country

Poland

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Links:

URL

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=732

Description

A Plain Language Trial Summary is available on novartisclinicaltrials.com

Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma (THUNDER)

Nasal Polyps

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial