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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 : Recruiting
First Posted : September 21, 2018
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
A Phase 3b Proof-of-Concept study to evaluate the ability of fevipiprant dose 1 and dose 2, 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
Asthma Nasal Polyps Bronchial Diseases Lung Diseases Nose Diseases Respiratory Hypersensitivity Hypersensitivity Drug: fevipiprant Dose 1 Drug: fevipiprant Dose 2 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 93 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
Estimated Primary Completion Date : August 28, 2020
Estimated Study Completion Date : August 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: fevipiprant Dose 1
QAW039 Dose 1 once daily orally
Drug: fevipiprant Dose 1
QAW039 Dose 1 once daily (one tablet of blinded QAW039 Dose 1 to be given together with one tablet of blinded placebo to QAW039 Dose 2)
Other Name: QAW039 Dose 1

Experimental: fevipiprant Dose 2
QAW039 Dose 2 once daily orally
Drug: fevipiprant Dose 2
QAW039 Dose 2 once daily (one tablet of blinded QAW039 Dose 2 to be given together with one tablet of blinded placebo to QAW039 Dose 1)
Other Name: QAW039 Dose 2

Placebo Comparator: Placebo
Placebo to QAW039 once daily orally
Drug: Placebo
Placebo to QAW039 once daily (one tablet blinded placebo to QAW039 Dose 1 and one tablet blinded placebo to QAW039 Dose 2)




Primary Outcome Measures :
  1. Nasal Polyp Score [ Time Frame: 16 weeks ]
    Change from baseline in Nasal Polyp Score (assessed by Nasal Endoscopy) following 16 weeks of treatment, compared to placebo. Total of 4 questions relating to nasal symptoms for the patients at the time the questionnaire is being administered. The questions score from 0 (not at all) to 3 (Severe).


Secondary Outcome Measures :
  1. Symptoms (Nasal Congestion Score) [ Time Frame: 16 weeks ]
    Change from baseline in symptoms score (assessed by Nasal Congestion Score questionnaire) following 16 weeks of treatment, compared to placebo. One questions relating to nasal symptoms for the patients at the time the questionnaire is being administered. The question score from 0 (not at all) to 3 (Severe). Only one question (is your nose blocked?) will be used for this secondary objective so the result will be a score from 0 to 3.

  2. Quality of Life (SNOT-22) [ Time Frame: 16 weeks ]
    Change from baseline in Quality of Life score (assessed using the SNOT-22 questionnaire) following 16 weeks of treatment, compared to placebo. A total of 22 questions relating to Sino-nasal quality of life and are asked relating to the previous 2 weeks. Each question has 6 possible answers ranging from 0 (No Problem) to 5 (Problem as bad as it can be). The scores are added together giving a result out of 110 for the patient at each time point.

  3. Smell (Smell Identification Test) [ Time Frame: 16 weeks ]
    Change from baseline in Smell score (assessed using the University of Pennsylvania Smell Identification Test) following 16 weeks of treatment, compared to placebo. This is a paper based kit consisting of 4 booklets with 10 questions each. Each question has a "scratch and sniff" panel which the site staff scratch off and the patient then has to smell this and identify the smell from 1 of the multiple choice responses. The result is a score out of 40 with the higher score indicating a better sense of smell.



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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


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, California
Novartis Investigative Site Recruiting
Pasadena, California, United States, 91101
Novartis Investigative Site Recruiting
Sacramento, California, United States, 95815
United States, Maryland
Novartis Investigative Site Recruiting
Baltimore, Maryland, United States, 21236
Argentina
Novartis Investigative Site Recruiting
Caba, Buenos Aires, Argentina, C1414AIF
Novartis Investigative Site Recruiting
Caba, Buenos Aires, Argentina, C1425BEN
Novartis Investigative Site Recruiting
Caba, Buenos Aires, Argentina, C1426ABP
Novartis Investigative Site Recruiting
Florida, Buenos Aires, Argentina, B1602DQD
Novartis Investigative Site Recruiting
Rosario, Santa Fe, Argentina, S2000DBS
Novartis Investigative Site Recruiting
San Miguel de Tucuman, Tucuman, Argentina, 4000
Novartis Investigative Site Recruiting
Buenos Aires, Argentina, C1125ABE
Novartis Investigative Site Recruiting
Mendoza, Argentina, 5500
Belgium
Novartis Investigative Site Recruiting
Bruxelles, Belgium, 1200
Novartis Investigative Site Recruiting
Erpent, Belgium, 5100
Novartis Investigative Site Recruiting
Gent, Belgium, 9000
Canada, Ontario
Novartis Investigative Site Recruiting
Ottawa, Ontario, Canada, K1G 6C6
Canada, Quebec
Novartis Investigative Site Recruiting
Montreal, Quebec, Canada, H4A 3J1
Canada
Novartis Investigative Site Recruiting
Quebec, Canada, G1V 4W2
Czechia
Novartis Investigative Site Recruiting
Olomouc, Czech Republic, Czechia, 779 00
Novartis Investigative Site Recruiting
Svitavy, Czech Republic, Czechia, 568 25
Novartis Investigative Site Recruiting
Kladno, Czechia, 27259
Germany
Novartis Investigative Site Recruiting
Dresden, Germany, 01307
Novartis Investigative Site Recruiting
Duesseldorf, Germany, 40225
Novartis Investigative Site Recruiting
Frankfurt, Germany, 60596
Italy
Novartis Investigative Site Recruiting
Rozzano, MI, Italy, 20089
Novartis Investigative Site Recruiting
Roma, RM, Italy, 00168
Netherlands
Novartis Investigative Site Recruiting
Amsterdam, Netherlands
Novartis Investigative Site Recruiting
Arnhem, Netherlands, 6815 AD
Novartis Investigative Site Recruiting
Enschede, Netherlands, 7511 JH
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03681093     History of Changes
Other Study ID Numbers: CQAW039A2322
2018-002073-22 ( EudraCT Number )
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019

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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 ):
Asthma
Nasal Polyposis
Nasal polyps score
nasal endoscopy
nasal congestion score
quality of life
smell
Additional relevant MeSH terms:
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Asthma
Lung Diseases
Nasal Polyps
Bronchial Diseases
Respiratory Hypersensitivity
Nose Diseases
Hypersensitivity
Polyps
Respiratory Tract Diseases
Lung Diseases, Obstructive
Hypersensitivity, Immediate
Immune System Diseases
Pathological Conditions, Anatomical
Otorhinolaryngologic Diseases
Indoleacetic Acids
Plant Growth Regulators
Growth Substances
Physiological Effects of Drugs