Nasal PolypsPhase 3THUNDERNCT03681093
Study of Efficacy of Fevipiprant in Patients With Nasal Polyposis and Asthma
A Phase 3 study testing Fevipiprant 150 mg and Fevipiprant 450 mg in people with Nasal Polyps, run by Novartis Pharmaceuticals at 25 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Polyps
- What is being tested?
- Fevipiprant 150 mg and Fevipiprant 450 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 25 sitesin 9 countries
- Study dates
- 26 Mar 2019to 10 Jun 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
25 sites in 9 countries.
25 sites in 9 countries
Argentina8 sites
Novartis Investigative Site
Buenos Aires, C1125ABE
Novartis Investigative Site
CABA, Buenos Aires, C1414AIF
Novartis Investigative Site
CABA, Buenos Aires, C1425BEN
Novartis Investigative Site
CABA, Buenos Aires, C1426ABP
Novartis Investigative Site
Florida, Buenos Aires, B1602DQD
Novartis Investigative Site
Mendoza, 5500
Novartis Investigative Site
Rosario, Santa Fe Province, S2000DBS
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, 4000
Czechia3 sites
Novartis Investigative Site
Kladno, 27259
Novartis Investigative Site
Olomouc, Czech Republic, 779 00
Novartis Investigative Site
Svitavy, Czech Republic, 568 25
Italy3 sites
Novartis Investigative Site
Pisa, PI, 56124
Novartis Investigative Site
Roma, RM, 00168
Novartis Investigative Site
Rozzano, MI, 20089
Belgium2 sites
Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Erpent, 5100
Canada2 sites
Novartis Investigative Site
Ottawa, Ontario, K1G 6C6
Novartis Investigative Site
Québec, G1V 4W2
Germany2 sites
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Frankfurt, 60596
Netherlands2 sites
Novartis Investigative Site
Amsterdam
Novartis Investigative Site
Enschede, 7511 JH
Poland2 sites
Novartis Investigative Site
Strzelce Opolskie, 47 100
Novartis Investigative Site
Zawadzkie, 47-120
United States1 site
Novartis Investigative Site
Irvine, California, 92618
About this study
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.
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.
Read the 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.
- Conditions
- Nasal Polyps
- Being tested
- Fevipiprant 150 mg, Fevipiprant 450 mg, Placebo
- Keywords
- Nasal Polyposis, Asthma, Nasal polyp score (NPS), Nasal congestion score (NCS), Bronchial Diseases, Lung Diseases, Nose Diseases, Respiratory Hypersensitivity, Fevipiprant, QAW039
- Medical subject headings
- Nasal Polyps, Asthma, Bronchial Diseases, Lung Diseases, Nose Diseases, Respiratory Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fevipiprant 150 mgDrug
Fevipiprant (QAW039) 150 mg once daily administered orally as tablet
Fevipiprant 450 mgDrug
Fevipiprant (QAW039) 450 mg once daily administered orally as tablet
PlaceboDrug
Placebo once daily administered orally as tablet
| Study group | Role | What they receive |
|---|---|---|
| Fevipiprant 150 mg | Experimental | Fevipiprant (QAW039) 150 mg once daily orally Receives: Drug: Fevipiprant 150 mg |
| Fevipiprant 450 mg | Experimental | Fevipiprant (QAW039) 450 mg once daily orally Receives: Drug: Fevipiprant 450 mg |
| Placebo | Placebo comparator | Placebo once daily orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 16
Secondary outcomes (3)
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.
Measured: Baseline, Week 16
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.
Measured: Baseline, Week 16
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.
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start26 Mar 2019
- Primary completion29 May 2020
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681093
- Sponsor's protocol ID
- CQAW039A2322
- Other IDs
- 2018-002073-22, 2018
- Acronym
- THUNDER
- Status last verified
- Oct 2021
- First submitted
- 20 Sep 2018
- Last updated
- 11 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03681093
- Acronym / sponsor ID
- THUNDER / CQAW039A2322
- Conditions
- Nasal Polyps
- Keywords
- Nasal Polyposis, Asthma, Nasal polyp score (NPS), Nasal congestion score (NCS), Bronchial Diseases, Lung Diseases, Nose Diseases, Respiratory Hypersensitivity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 29 May 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 21 Sep 2018 (actual)
- Results
- Posted 5 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fevipiprant 150 mg | Experimental | Drug: Fevipiprant 150 mgFevipiprant (QAW039) 150 mg once daily orally |
| Fevipiprant 450 mg | Experimental | Drug: Fevipiprant 450 mgFevipiprant (QAW039) 450 mg once daily orally |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once daily orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fevipiprant 150 mgFevipiprant (QAW039) 150 mg once daily administered orally as tablet | Drug | Fevipiprant 150 mg |
| Fevipiprant 450 mgFevipiprant (QAW039) 450 mg once daily administered orally as tablet | Drug | Fevipiprant 450 mg |
| PlaceboPlacebo once daily administered orally as tablet | Drug | Placebo |
Primary outcome
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.
3 secondary outcomes
Change From Baseline in Nasal Congestion Score at Week 16
Time frame: Baseline, Week 16
Change From Baseline in Quality of Life as Assessed by the SNOT-22 Questionnaire at Week 16
Time frame: Baseline, Week 16
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on novartisclinicaltrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fevipiprant 150 mg and Fevipiprant 450 mg in people with Nasal Polyps, run by Novartis Pharmaceuticals at 25 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Argentina, Czechia, Italy, Belgium, Canada and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Nasal Polyp Score at Week 16 (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.