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Systemic Corticosteroids Avoidance Study in Severe Asthma Patients

Primary Purpose

Asthma

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo once daily

QAW039 150 mg once daily

QAW039 450 mg once daily

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases, Respiratory Hypersensitivity, Hypersensitivity, Immune System Diseases, Fevipiprant, QAW039

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

QAW039 150 mg

QAW039 450 mg

Placebo

Arm Description

QAW039 150 mg once daily orally

QAW039 450 mg once daily orally

Placebo to QAW039 once daily orally

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Change From Baseline in Daytime Symptom Scores

All participants were provided with an electronic diary (eDiary/ePEF) to record asthma symptom twice per day. Daytime asthma symptoms were assessed before bed and nighttime asthma symptoms on awakening. The daytime asthma symptom score included 4 questions with a range of response categories for each question from 0 to 6 (0 = totally controlled; 6 = extremely poorly controlled). The questions were equally weighted and the overall score (from 0 to 6) was calculated as the average of the 4 questions with higher values indicating more asthma symptoms. Mean values of daytime asthma symptom scores were calculated over 4-week intervals during the treatment period. The baseline values of daytime asthma symptoms scores were defined as the average score during the run-in period. A negative change from baseline in daytime asthma symptom score is a favorable outcome.

Change From Baseline in Nighttime Symptom Scores

All participants were provided with an electronic diary (eDiary/ePEF) to record asthma symptom twice per day. Daytime asthma symptoms were assessed before bed and nighttime asthma symptoms on awakening. The nighttime asthma symptom score included 1 question with a range of response categories from 0 to 3 (0 = no awakening with asthma symptoms; 3 = awake all night). Mean values of nighttime asthma symptom scores were calculated over 4-week intervals during the treatment period. The baseline values of nighttime asthma symptoms scores were defined as the average score during the run-in period. A negative change from baseline in nighttime asthma symptom score is a favorable outcome.

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

The Asthma Control Questionnaire (ACQ-5) was completed by the patients at the investigator's site. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions were equally weighted and the ACQ-5 score was the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). The baseline values of ACQ-5 score were defined as the ACQ-5 scores obtained on Day 1. A negative change from baseline in ACQ-5 score is a favorable outcome.

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

The Asthma Quality of Life Questionnaire (AQLQ+12) was completed by the patients at the investigator's site. The AQLQ+12 is a 32-item disease specific questionnaire designed to measure functional impairments that are most important to patients with asthma. Patients were asked to recall their experiences during the previous 2 weeks and to score each of the 32 items on a 7-point scale, where 1 indicates maximal impairment and 7 indicates no impairment. Thus, higher scores indicate better asthma-related quality of life. Each item of the AQLQ+12 was equally weighted and the overall score was the mean score of all 32 items and therefore ranged between 1 and 7. The baseline values of AQLQ+12 score were defined as the AQLQ+12 scores obtained on Day 1. A positive change from baseline in AQLQ+12 score is a favorable outcome.

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

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) to record medication use. Daily use of oral corticosteroids (the number of tablets taken in the previous 12 hours) was recorded once in the morning and once in the evening by the subject using 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 percentage of patients requiring ≥ 7.5 mg systemic corticosteroid dose in mg prednisone/prednisolone (or equivalent) per day continuously for at least 30 days within the on-treatment period is presented in this record.

Percentage of Patients With no Systemic Corticosteroids Use

Percentage of Patients With Prescription of Biologic Therapy

As part of the flexible therapy, investigators were allowed to prescribe biologics approved for asthma from randomization visit onwards. Prescription of biologic therapy during the treatment period was recorded. The proportion of patients with prescription of biologic therapy during the on-treatment period is presented in this record.

Full Information

NCT ID

NCT03629249

First Posted

August 9, 2018

Last Updated

October 7, 2021

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03629249

Brief Title

Systemic Corticosteroids Avoidance Study in Severe Asthma Patients

Official Title

A 52-week, Multicenter, Randomized, Double-blind, Double-dummy, Parallel-group, Placebo-controlled Study of Fevipiprant Once Daily Plus Standard-of-care (SoC) for Reduction of Systemic Corticosteroids (Oral and Parenteral) Use in Patients With Severe Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Terminated

Why Stopped

Company decision

Study Start Date

December 13, 2018 (Actual)

Primary Completion Date

February 6, 2020 (Actual)

Study Completion Date

February 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

This was a randomized, multicenter, double-blind, double-dummy, placebo-controlled, parallel-group study to determine the ability of fevipiprant (QAW039) plus standard-of-care (SoC) compared with placebo plus SoC to reduce the use of systemic corticosteroids (SCS) in patients with severe asthma. The study included: a Screening period of up to 2 weeks to assess eligibility; a Run-in period of 4 or 10 weeks to evaluate maintenance of asthma control and to collect baseline safety data. The Run-in period was 4 weeks for patients coming with high-dose ICS/LABA (inhaled corticosteroids/long-acting beta-agonist) and 10 weeks for patients switching from mid-dose to high-dose ICS/LABA as per protocol during the run-in period; a Treatment period of 52 weeks. Upon completion of the Run-in period, all patients who met eligibility criteria were randomized to 1 of 3 treatment groups (fevipiprant 150 mg or 450 mg or placebo once daily) in a ratio 1:1:1. Randomized patients were stratified according to their peripheral blood eosinophil count (< 250 cells/μl or ≥ 250 cells/μl); a Follow-up period of 2 weeks following the last dose of study drug to collect additional data for safety variables. The main 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 GINA (Global Initiative for Asthma) treatment step 4 or 5 SoC asthma therapy in terms of avoidance of SCS use over 52 weeks in patients with inadequately controlled severe asthma and high eosinophil counts (eosinophil count at Visit 1 ≥250 cells/ μl) and in the overall patient population regardless of eosinophil counts. On 16-Dec-2019 the sponsor decided to terminate study CQAW039A2323 earlier than the planned study completion. There were no safety findings with fevipiprant that contributed to this decision. The planned treatment period of 52 weeks was not completed by any patient; patients were treated for a median time of 14 weeks in each group and a maximum of up to 36 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

604 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QAW039 150 mg

Arm Type

Experimental

Arm Description

QAW039 150 mg once daily orally

Arm Title

QAW039 450 mg

Arm Type

Experimental

Arm Description

QAW039 450 mg once daily orally

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo to QAW039 once daily orally

Intervention Type

Drug

Intervention Name(s)

Placebo once daily

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

QAW039 150 mg once daily

Other Intervention Name(s)

fevipiprant 150 mg

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

QAW039 450 mg once daily

Other Intervention Name(s)

fevipiprant 450 mg

Intervention Description

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)

Primary Outcome Measure Information:

Title

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

Description

Time Frame

52 weeks

Title

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)

Description

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.

Time Frame

52 weeks

Secondary Outcome Measure Information:

Title

Change From Baseline in Daytime Symptom Scores

Description

Time Frame

Baseline, up to Week 29-32

Title

Change From Baseline in Nighttime Symptom Scores

Description

All participants were provided with an electronic diary (eDiary/ePEF) to record asthma symptom twice per day. Daytime asthma symptoms were assessed before bed and nighttime asthma symptoms on awakening. The nighttime asthma symptom score included 1 question with a range of response categories from 0 to 3 (0 = no awakening with asthma symptoms; 3 = awake all night). Mean values of nighttime asthma symptom scores were calculated over 4-week intervals during the treatment period. The baseline values of nighttime asthma symptoms scores were defined as the average score during the run-in period. A negative change from baseline in nighttime asthma symptom score is a favorable outcome.

Time Frame

Baseline, up to Week 29-32

Title

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

Description

Time Frame

Baseline, up to Week 28

Title

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

Description

Time Frame

Baseline, up to Week 28

Title

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

Description

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) to record medication use. Daily use of oral corticosteroids (the number of tablets taken in the previous 12 hours) was recorded once in the morning and once in the evening by the subject using 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 percentage of patients requiring ≥ 7.5 mg systemic corticosteroid dose in mg prednisone/prednisolone (or equivalent) per day continuously for at least 30 days within the on-treatment period is presented in this record.

Time Frame

Up to 36 weeks

Title

Percentage of Patients With no Systemic Corticosteroids Use

Description

Time Frame

Week 36

Title

Percentage of Patients With Prescription of Biologic Therapy

Description

Time Frame

Up to 36 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

84 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Facility Information:

Facility Name

Novartis Investigative Site

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

Novartis Investigative Site

City

Westminster

State/Province

California

ZIP/Postal Code

92683

Country

United States

Facility Name

Novartis Investigative Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Novartis Investigative Site

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Novartis Investigative Site

City

Waldorf

State/Province

Maryland

ZIP/Postal Code

20602

Country

United States

Facility Name

Novartis Investigative Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10459

Country

United States

Facility Name

Novartis Investigative Site

City

Boerne

State/Province

Texas

ZIP/Postal Code

78006

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Novartis Investigative Site

City

McKinney

State/Province

Texas

ZIP/Postal Code

75069

Country

United States

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1122AAK

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1424BSF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Florida

State/Province

Buenos Aires

ZIP/Postal Code

B1602DQD

Country

Argentina

Facility Name

Novartis Investigative Site

City

Mar del Plata

State/Province

Buenos Aires

ZIP/Postal Code

7600

Country

Argentina

Facility Name

Novartis Investigative Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000DBS

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Novartis Investigative Site

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

T4000IFL

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

1428

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

1900

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1012AAR

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1125ABE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Buenos Aires

ZIP/Postal Code

C1440BRR

Country

Argentina

Facility Name

Novartis Investigative Site

City

Caba

Country

Argentina

Facility Name

Novartis Investigative Site

City

Cordoba

ZIP/Postal Code

X5003DCE

Country

Argentina

Facility Name

Novartis Investigative Site

City

Erpent

ZIP/Postal Code

5100

Country

Belgium

Facility Name

Novartis Investigative Site

City

Lebbeke

ZIP/Postal Code

9280

Country

Belgium

Facility Name

Novartis Investigative Site

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Mechelen

ZIP/Postal Code

2800

Country

Belgium

Facility Name

Novartis Investigative Site

City

Vidin

State/Province

BGR

ZIP/Postal Code

3703

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Santiago

State/Province

Region Metropolitana

ZIP/Postal Code

7500692

Country

Chile

Facility Name

Novartis Investigative Site

City

Curico

State/Province

VII Region Del Maule

ZIP/Postal Code

3341643

Country

Chile

Facility Name

Novartis Investigative Site

City

Zipaquira

State/Province

Cundinamarca

ZIP/Postal Code

250252

Country

Colombia

Facility Name

Novartis Investigative Site

City

Bogota

ZIP/Postal Code

110221

Country

Colombia

Facility Name

Novartis Investigative Site

City

Bogota

ZIP/Postal Code

110231

Country

Colombia

Facility Name

Novartis Investigative Site

City

Bucaramanga

Country

Colombia

Facility Name

Novartis Investigative Site

City

Beroun

State/Province

Czech Republic

ZIP/Postal Code

266 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 4

State/Province

Czech Republic

ZIP/Postal Code

140 46

Country

Czechia

Facility Name

Novartis Investigative Site

City

Teplice

State/Province

Czech Republic

ZIP/Postal Code

415 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Teplice

State/Province

CZE

ZIP/Postal Code

415 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Jindrichuv Hradec

ZIP/Postal Code

377 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Lovosice

ZIP/Postal Code

41002

Country

Czechia

Facility Name

Novartis Investigative Site

City

Varnsdorf

ZIP/Postal Code

40747

Country

Czechia

Facility Name

Novartis Investigative Site

City

Montpellier cedex 5

State/Province

Herault

ZIP/Postal Code

34059

Country

France

Facility Name

Novartis Investigative Site

City

Lyon cedex 04

State/Province

Rhone

ZIP/Postal Code

69317

Country

France

Facility Name

Novartis Investigative Site

City

Grenoble Cedex 9

ZIP/Postal Code

38043

Country

France

Facility Name

Novartis Investigative Site

City

Pessac Cedex

ZIP/Postal Code

33604

Country

France

Facility Name

Novartis Investigative Site

City

Koblenz

State/Province

NRW

ZIP/Postal Code

56068

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10119

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10717

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10969

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12159

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13187

Country

Germany

Facility Name

Novartis Investigative Site

City

Darmstadt

ZIP/Postal Code

64283

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60389

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22299

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30173

Country

Germany

Facility Name

Novartis Investigative Site

City

Landsberg

ZIP/Postal Code

86899

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04275

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04357

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35037

Country

Germany

Facility Name

Novartis Investigative Site

City

Witten

ZIP/Postal Code

58452

Country

Germany

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

115 25

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

564 29

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

570 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Heraklion Crete

ZIP/Postal Code

711 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Gyor

State/Province

HUN

ZIP/Postal Code

9024

Country

Hungary

Facility Name

Novartis Investigative Site

City

Hajdunanas

State/Province

HUN

ZIP/Postal Code

4080

Country

Hungary

Facility Name

Novartis Investigative Site

City

Kapuvár

State/Province

HUN

ZIP/Postal Code

9330

Country

Hungary

Facility Name

Novartis Investigative Site

City

Puspokladany

State/Province

HUN

ZIP/Postal Code

4150

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szazhalombatta

State/Province

HUN

ZIP/Postal Code

2440

Country

Hungary

Facility Name

Novartis Investigative Site

City

Balassagyarmat

ZIP/Postal Code

2660

Country

Hungary

Facility Name

Novartis Investigative Site

City

Godollo

ZIP/Postal Code

2100

Country

Hungary

Facility Name

Novartis Investigative Site

City

Nyiregyhaza

ZIP/Postal Code

H-4400

Country

Hungary

Facility Name

Novartis Investigative Site

City

Pecs

ZIP/Postal Code

7635

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6722

Country

Hungary

Facility Name

Novartis Investigative Site

City

San Isidro

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Cusco

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Piura

Country

Peru

Facility Name

Novartis Investigative Site

City

Lipa City

State/Province

Batangas

ZIP/Postal Code

4217

Country

Philippines

Facility Name

Novartis Investigative Site

City

Iloilo city

State/Province

Iloilo

ZIP/Postal Code

5000

Country

Philippines

Facility Name

Novartis Investigative Site

City

Iloilo City

ZIP/Postal Code

5000

Country

Philippines

Facility Name

Novartis Investigative Site

City

Iloilo

ZIP/Postal Code

5000

Country

Philippines

Facility Name

Novartis Investigative Site

City

Barnaul

ZIP/Postal Code

656045

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

115682

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

125993

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Petrozavodsk

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

198260

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint-Petersburg

ZIP/Postal Code

196143

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saratov

ZIP/Postal Code

410012

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

193312

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

194325

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Stavropol

ZIP/Postal Code

355000

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Volgograd

ZIP/Postal Code

400120

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Bardejov

State/Province

Slovak Republic

ZIP/Postal Code

085 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Humenne

State/Province

Slovak Republic

ZIP/Postal Code

066 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Levice

State/Province

Slovak Republic

ZIP/Postal Code

934 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Spisska Nova Ves

State/Province

Slovak Republic

ZIP/Postal Code

052 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Zilina

ZIP/Postal Code

010 01

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Berea

State/Province

Durban

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Novartis Investigative Site

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Novartis Investigative Site

City

Marbella

State/Province

Andalucia

ZIP/Postal Code

29603

Country

Spain

Facility Name

Novartis Investigative Site

City

Badalona

State/Province

Catalunya

ZIP/Postal Code

08916

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Novartis Investigative Site

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novartis Investigative Site

City

Mersin

ZIP/Postal Code

33343

Country

Turkey

Facility Name

Novartis Investigative Site

City

Portsmouth

State/Province

Hants

ZIP/Postal Code

PO6 3LY

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Chertsey

State/Province

Surrey

ZIP/Postal Code

KT16 0PZ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bradford

State/Province

West Yorkshire

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Hanoi

ZIP/Postal Code

100000

Country

Vietnam

Facility Name

Novartis Investigative Site

City

Hanoi

ZIP/Postal Code

10000

Country

Vietnam

Facility Name

Novartis Investigative Site

City

Ho Chi Minh

Country

Vietnam

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Links:

URL

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=727

Description

A Plain Language Trial Summary is available on novartisclinicaltrials.com

Learn more about this trial

Systemic Corticosteroids Avoidance Study in Severe Asthma Patients

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Systemic Corticosteroids Avoidance Study in Severe Asthma Patients

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial