Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma
THUNDER
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.
2 other identifiers
interventional
98
9 countries
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2019
Shorter than P25 for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2018
CompletedFirst Posted
Study publicly available on registry
September 21, 2018
CompletedStudy Start
First participant enrolled
March 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2020
CompletedResults Posted
Study results publicly available
January 5, 2021
CompletedOctober 11, 2021
October 1, 2021
1.2 years
September 20, 2018
December 9, 2020
October 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, Week 16
Secondary Outcomes (3)
Change From Baseline in Nasal Congestion Score at Week 16
Baseline, Week 16
Change From Baseline in Quality of Life as Assessed by the SNOT-22 Questionnaire at Week 16
Baseline, Week 16
Change From Baseline in Sense of Smell as Assessed by the University of Pennsylvania Smell Identification Test (UPSIT) at Week 16
Baseline, Week 16
Study Arms (3)
Fevipiprant 150 mg
EXPERIMENTALFevipiprant (QAW039) 150 mg once daily orally
Fevipiprant 450 mg
EXPERIMENTALFevipiprant (QAW039) 450 mg once daily orally
Placebo
PLACEBO COMPARATORPlacebo once daily orally
Interventions
Fevipiprant (QAW039) 150 mg once daily administered orally as tablet
Fevipiprant (QAW039) 450 mg once daily administered orally as tablet
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Novartis Investigative Site
Irvine, California, 92618, United States
Novartis Investigative Site
CABA, Buenos Aires, C1414AIF, Argentina
Novartis Investigative Site
CABA, Buenos Aires, C1425BEN, Argentina
Novartis Investigative Site
CABA, Buenos Aires, C1426ABP, Argentina
Novartis Investigative Site
Florida, Buenos Aires, B1602DQD, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, S2000DBS, Argentina
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Novartis Investigative Site
Buenos Aires, C1125ABE, Argentina
Novartis Investigative Site
Mendoza, 5500, Argentina
Novartis Investigative Site
Brussels, 1200, Belgium
Novartis Investigative Site
Erpent, 5100, Belgium
Novartis Investigative Site
Ottawa, Ontario, K1G 6C6, Canada
Novartis Investigative Site
Québec, G1V 4W2, Canada
Novartis Investigative Site
Olomouc, Czech Republic, 779 00, Czechia
Novartis Investigative Site
Svitavy, Czech Republic, 568 25, Czechia
Novartis Investigative Site
Kladno, 27259, Czechia
Novartis Investigative Site
Dresden, 01307, Germany
Novartis Investigative Site
Frankfurt, 60596, Germany
Novartis Investigative Site
Rozzano, MI, 20089, Italy
Novartis Investigative Site
Pisa, PI, 56124, Italy
Novartis Investigative Site
Roma, RM, 00168, Italy
Novartis Investigative Site
Amsterdam, Netherlands
Novartis Investigative Site
Enschede, 7511 JH, Netherlands
Novartis Investigative Site
Strzelce Opolskie, 47 100, Poland
Novartis Investigative Site
Zawadzkie, 47-120, Poland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double blind, double dummy study design.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2018
First Posted
September 21, 2018
Study Start
March 26, 2019
Primary Completion
May 29, 2020
Study Completion
June 10, 2020
Last Updated
October 11, 2021
Results First Posted
January 5, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
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.