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

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ClinicalTrials.gov Identifier: NCT03681093
Recruitment Status : Completed
First Posted : September 21, 2018
Results First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Nasal Polyps Drug: Fevipiprant 150 mg Drug: Fevipiprant 450 mg Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double blind, double dummy study design.
Primary Purpose: Treatment
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.
Actual Study Start Date : March 26, 2019
Actual Primary Completion Date : May 29, 2020
Actual Study Completion Date : June 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Fevipiprant 150 mg
Fevipiprant (QAW039) 150 mg once daily orally
Drug: Fevipiprant 150 mg
Fevipiprant (QAW039) 150 mg once daily administered orally as tablet

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

Placebo Comparator: Placebo
Placebo once daily orally
Drug: Placebo
Placebo once daily administered orally as tablet




Primary Outcome Measures :
  1. Change From Baseline in Nasal Polyp Score at Week 16 [ Time Frame: 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 Outcome Measures :
  1. Change From Baseline in Nasal Congestion Score at Week 16 [ Time Frame: 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.


  2. Change From Baseline in Quality of Life as Assessed by the SNOT-22 Questionnaire at Week 16 [ Time Frame: 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.


  3. Change From Baseline in Sense of Smell as Assessed by the University of Pennsylvania Smell Identification Test (UPSIT) at Week 16 [ Time Frame: 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03681093


Locations
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United States, California
Novartis Investigative Site
Irvine, California, United States, 92618
Argentina
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1414AIF
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1425BEN
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1426ABP
Novartis Investigative Site
Florida, Buenos Aires, Argentina, B1602DQD
Novartis Investigative Site
Rosario, Santa Fe, Argentina, S2000DBS
Novartis Investigative Site
San Miguel de Tucuman, Tucuman, Argentina, 4000
Novartis Investigative Site
Buenos Aires, Argentina, C1125ABE
Novartis Investigative Site
Mendoza, Argentina, 5500
Belgium
Novartis Investigative Site
Bruxelles, Belgium, 1200
Novartis Investigative Site
Erpent, Belgium, 5100
Canada, Ontario
Novartis Investigative Site
Ottawa, Ontario, Canada, K1G 6C6
Canada
Novartis Investigative Site
Quebec, Canada, G1V 4W2
Czechia
Novartis Investigative Site
Olomouc, Czech Republic, Czechia, 779 00
Novartis Investigative Site
Svitavy, Czech Republic, Czechia, 568 25
Novartis Investigative Site
Kladno, Czechia, 27259
Germany
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Frankfurt, Germany, 60596
Italy
Novartis Investigative Site
Rozzano, MI, Italy, 20089
Novartis Investigative Site
Pisa, PI, Italy, 56124
Novartis Investigative Site
Roma, RM, Italy, 00168
Netherlands
Novartis Investigative Site
Amsterdam, Netherlands
Novartis Investigative Site
Enschede, Netherlands, 7511 JH
Poland
Novartis Investigative Site
Strzelce Opolskie, Poland, 47 100
Novartis Investigative Site
Zawadzkie, Poland, 47-120
Sponsors and Collaborators
Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Statistical Analysis Plan  [PDF] July 20, 2020
Study Protocol  [PDF] September 24, 2019

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03681093    
Other Study ID Numbers: CQAW039A2322
2018-002073-22 ( EudraCT Number )
First Posted: September 21, 2018    Key Record Dates
Results First Posted: January 5, 2021
Last Update Posted: January 5, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Nasal Polyposis
Asthma
Nasal polyp score (NPS)
Nasal congestion score (NCS)
Bronchial Diseases
Lung Diseases
Nose Diseases
Respiratory Hypersensitivity
Fevipiprant
QAW039
Additional relevant MeSH terms:
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Nasal Polyps
Polyps
Respiratory Tract Diseases
Pathological Conditions, Anatomical
Nose Diseases
Otorhinolaryngologic Diseases
Indoleacetic Acids
Plant Growth Regulators
Growth Substances
Physiological Effects of Drugs