Systemic Corticosteroids Avoidance Study in Severe Asthma Patients

NCT03629249 | Terminated Phase 3 Results FDA Drug

• 2 other identifiers: CQAW039A23232018-000212-25
• Study Type: interventional
• Target: 604
• Locations: 21 countries
• Sites: 120

Brief Summary

The overall purpose of this study was to determine the efficacy of fevipiprant (150 mg and 450 mg once daily), compared with placebo, as add-on to standard-of-care asthma therapy, in terms of avoidance of corticosteroid use over 52 weeks.

Conditions

Asthma

Keywords

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases; Obstructive Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity; Immune System Diseases; Fevipiprant; QAW039

Outcome Measures

Primary Outcomes (2)

• Total Systemic Corticosteroid Dose in mg Prednisone/Prednisolone or Equivalent Over 52 Weeks in the Overall Population

  All participants were provided with prednisone/prednisolone (or equivalent) tablets that could be used according to the asthma plan along with an electronic diary (e-Diary/ePEF). Daily use of oral corticosteroids (number of tablets taken in the previous 12 hours) was recorded once in the morning and once in the evening by the subject in the eDiary/PEF device. In case of use of injectable corticosteroids during certain circumstances (eg. hospitalization) the data was collected on the eCRF (electronic case report form). The total systemic corticosteroids (SCS) dose data was aggregated into monthly data for analysis. For the patients discontinuing treatment early, the total SCS dose for 52 weeks was obtained as annualized SCS dose. For example if patient took 120 mg for 3 months then for 12 months patient will be taking 120\*12/3=480mg total SCS dose. The mean values over 52 weeks in the overall patient population regardless of peripheral blood eosinophil counts are reported here.

  52 weeks

• Total Systemic Corticosteroid Dose in mg Prednisone/Prednisolone or Equivalent Over 52 Weeks in the Subpopulation of Patients With High Eosinophil Count (≥ 250 Cells/µl)

  All participants were provided with prednisone/prednisolone (or equivalent) tablets that could be used according to the asthma plan along with an electronic diary (e-Diary/ePEF). Daily use of oral corticosteroids (number of tablets taken in the previous 12 hours) was recorded once in the morning and once in the evening by the subject in the eDiary/PEF device. In case of use of injectable corticosteroids during certain circumstances (eg. hospitalization) the data was collected on the eCRF (electronic case report form). The total systemic corticosteroids (SCS) dose data was aggregated into monthly data for analysis. For the patients discontinuing treatment early, the total SCS dose for 52 weeks was obtained as annualized SCS dose. For example if patient took 120 mg for 3 months then for 12 months patient will be taking 120\*12/3=480mg total SCS dose. The mean values over 52 weeks in the subpopulation of patients with high peripheral blood eosinophil count at baseline are reported here.

  52 weeks

Secondary Outcomes (7)

• Change From Baseline in Daytime Symptom Scores

  Baseline, up to Week 29-32

• Change From Baseline in Nighttime Symptom Scores

  Baseline, up to Week 29-32

• Change From Baseline in ACQ-5 Total Score up to End of Treatment Visit

  Baseline, up to Week 28

• Change From Baseline in AQLQ+12 Total Score up to End of Treatment Visit

  Baseline, up to Week 28

• Percentage of Patients Requiring ≥ 7.5 mg Systemic Corticosteroid Dose in mg Prednisone/Prednisolone or Equivalent Per Day Continuously for at Least 30 Days

  Up to 36 weeks

Study Arms (3)

QAW039 150 mg

EXPERIMENTAL

QAW039 150 mg once daily orally

Drug: QAW039 150 mg once daily

QAW039 450 mg

EXPERIMENTAL

QAW039 450 mg once daily orally

Drug: QAW039 450 mg once daily

Placebo

PLACEBO COMPARATOR

Placebo to QAW039 once daily orally

Drug: Placebo once daily

Interventions

Placebo once daily DRUG

Placebo to QAW039 once daily (one tablet blinded placebo to QAW039 150 mg and one tablet blinded placebo to QAW039 450 mg).

Placebo

QAW039 150 mg once daily DRUG

QAW039 150 mg once daily (one tablet of blinded QAW039 150 mg to be given together with one tablet blinded placebo to QAW039 450 mg)

Also known as: fevipiprant 150 mg

QAW039 150 mg

QAW039 450 mg once daily DRUG

QAW039 450 mg once daily (one tablet of blinded QAW039 450 mg to be given together with one tablet blinded placebo to QAW039 150 mg)

Also known as: fevipiprant 450 mg

QAW039 450 mg

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a diagnosis of asthma for a period of at least 3 months prior to Screening Visit with current asthma severity step 4 or 5 (GINA 2018)
• Currently on treatment with medium or high dose ICS/LABA +/- other controller (i.e.long-acting muscarinic antagonist (LAMA), leukotriene receptor antagonist (LTRA) etc. as per GINA) for a minimum of 6 weeks prior to Screening Visit
• At screening, patients with FEV1 of ≤80% of the predicted normal value for the patient, after withholding bronchodilators at Screening Visit and beginning of Run-In Visit
• An increase of ≥12% and ≥200 ml in FEV1 approximately 10 to 15 minutes after administration of 400 mcg of salbutamol/albuterol prior to randomization (documented historical reversibility was accepted).
• Demonstration of inadequate control of asthma based on an ACQ-5 score ≥1.5 at Screening Visit and Treatment Day 1 Visit
• Documented history of at least 1 asthma exacerbation within 1 year prior to enrollment

You may not qualify if:

• Asthma exacerbation, within 6 weeks prior to enrollment (screening) that required SCS, hospitalization, or emergency room visit
• Chronic/maintenance use of oral corticosteroids (OCS) for asthma (total OCS use days greater than 6 months; continuously or intermittently) within the last year
• Prior use of biologics that has potential to interfere/ affect asthma disease progression, in the previous 6 months from run-in period.
• Any contraindications of SCS use e.g. diabetes, narrow angle glaucoma, or any other as defined by the treating physician
• Pregnant or nursing (lactating) women
• Use of other investigational drugs within 5 half-lives of enrollment, or \[within 30 days\], whichever is longer

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (120)

Novartis Investigative Site

Newport Beach, California, 92663, United States

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Westminster, California, 92683, United States

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Winter Park, Florida, 32789, United States

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Bangor, Maine, 04401, United States

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Waldorf, Maryland, 20602, United States

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The Bronx, New York, 10459, United States

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Boerne, Texas, 78006, United States

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Dallas, Texas, 75230, United States

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McKinney, Texas, 75069, United States

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CABA, Buenos Aires, C1122AAK, Argentina

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CABA, Buenos Aires, C1424BSF, Argentina

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Florida, Buenos Aires, B1602DQD, Argentina

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Mar del Plata, Buenos Aires, 7600, Argentina

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Rosario, Santa Fe Province, S2000DBS, Argentina

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San Miguel de Tucumán, Tucumán Province, 4000, Argentina

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San Miguel de Tucumán, Tucumán Province, T4000IFL, Argentina

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Buenos Aires, 1428, Argentina

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Buenos Aires, 1900, Argentina

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Buenos Aires, C1012AAR, Argentina

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Buenos Aires, C1125ABE, Argentina

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Buenos Aires, C1440BRR, Argentina

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CABA, Argentina

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Córdoba, X5003DCE, Argentina

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Erpent, 5100, Belgium

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Lebbeke, 9280, Belgium

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Liège, 4000, Belgium

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Mechelen, 2800, Belgium

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Vidin, BGR, 3703, Bulgaria

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Pleven, 5800, Bulgaria

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Sofia, 1407, Bulgaria

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Curicó, Maule Region, 3341643, Chile

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Santiago, Santiago Metropolitan, 7500692, Chile

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Zipaquirá, Cundinamarca, 250252, Colombia

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Bogotá, 110221, Colombia

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Bogotá, 110231, Colombia

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Bucaramanga, Colombia

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Beroun, Czech Republic, 266 01, Czechia

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Prague, Czech Republic, 140 46, Czechia

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Teplice, Czech Republic, 415 01, Czechia

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Teplice, CZE, 415 01, Czechia

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Jindřichův Hradec, 377 01, Czechia

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Lovosice, 41002, Czechia

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Varnsdorf, 40747, Czechia

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Montpellier, Herault, 34059, France

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Lyon, Rhone, 69317, France

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Grenoble, 38043, France

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Pessac, 33604, France

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Koblenz, North Rhine-Westphalia, 56068, Germany

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Berlin, 10119, Germany

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Berlin, 10717, Germany

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Berlin, 10969, Germany

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Berlin, 12159, Germany

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Berlin, 12203, Germany

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Berlin, 13187, Germany

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Darmstadt, 64283, Germany

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Frankfurt, 60389, Germany

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Frankfurt, 60596, Germany

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Hamburg, 20354, Germany

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Hamburg, 22299, Germany

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Hanover, 30173, Germany

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Landsberg, 86899, Germany

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Leipzig, 04103, Germany

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Leipzig, 04275, Germany

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Leipzig, 04357, Germany

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Mainz, 55131, Germany

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Marburg, 35037, Germany

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Witten, 58452, Germany

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Heraklion Crete, Greece, 711 10, Greece

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Athens, GR, 115 25, Greece

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Athens, GR, 115 27, Greece

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Thessaloniki, GR, 564 29, Greece

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Thessaloniki, GR, 570 10, Greece

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Győr, HUN, 9024, Hungary

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Hajdúnánás, HUN, 4080, Hungary

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Kapuvár, HUN, 9330, Hungary

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Püspökladány, HUN, 4150, Hungary

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Százhalombatta, HUN, 2440, Hungary

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Balassagyarmat, 2660, Hungary

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Gödöllő, 2100, Hungary

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Nyíregyháza, H-4400, Hungary

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Pécs, 7635, Hungary

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Szeged, 6722, Hungary

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San Isidro, Lima region, 27, Peru

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Cusco, 84, Peru

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Lima, 1, Peru

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Piura, Peru

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Lipa City, Batangas, 4217, Philippines

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Iloilo City, Iloilo, 5000, Philippines

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Iloilo City, 5000, Philippines

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Barnaul, 656045, Russia

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Moscow, 115478, Russia

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Moscow, 115682, Russia

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Moscow, 125993, Russia

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Petrozavodsk, 185019, Russia

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Saint Petersburg, 193312, Russia

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Saint Petersburg, 194325, Russia

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Saint Petersburg, 196143, Russia

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Saint Petersburg, 198260, Russia

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Saratov, 410012, Russia

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Stavropol, 355000, Russia

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Volgograd, 400120, Russia

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Bardejov, Slovak Republic, 085 01, Slovakia

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Humenné, Slovak Republic, 066 01, Slovakia

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Levice, Slovak Republic, 934 01, Slovakia

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Spišská Nová Ves, Slovak Republic, 052 01, Slovakia

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Žilina, 010 01, Slovakia

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Berea, Durban, 4001, South Africa

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Cape Town, 7925, South Africa

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Marbella, Andalusia, 29603, Spain

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Badalona, Catalonia, 08916, Spain

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Madrid, 28006, Spain

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Santiago de Compostela, 15706, Spain

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Bangkok, 10400, Thailand

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Mersin, 33343, Turkey (Türkiye)

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Portsmouth, Hants, PO6 3LY, United Kingdom

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Chertsey, Surrey, KT16 0PZ, United Kingdom

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Bradford, West Yorkshire, BD9 6RJ, United Kingdom

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Hanoi, 100000, Vietnam

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Novartis Investigative Site

Hanoi, 10000, Vietnam

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Novartis Investigative Site

Ho Chi Minh City, Vietnam

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Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Conditions

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Immune System Diseases

Interventions

fevipiprant

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 14, 2018
• Study Start: December 13, 2018
• Primary Completion: February 6, 2020
• Study Completion: February 6, 2020
• Last Updated: October 11, 2021
• Results First Posted: February 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

VN (3); PH (3); ES (4); DE (20); BE (4); GR (5); CL (2); GB (3); AR (14); CZ (7); SL (5); CO (4); FR (4); US (9); ZA (2); TU (1); PE (4); TH (1); RU (12); HU (10); BU (3)