Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Systemic Corticosteroids Avoidance Study in Severe Asthma Patients (QAW039A)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03629249
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The overall purpose of this study is to determine the efficacy of fevipiprant (dose 1 and dose 2 once daily), compared with placebo, as add-on to standard-of-care asthma therapy, in terms of avoidance of coricosteroid use over 52 weeks.

Condition or disease Intervention/treatment Phase
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Physiological Effects of Drugs Drug: Placebo Drug: QAW039 Dose 1 Drug: QAW039 Dose 2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 669 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 13, 2018
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

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

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




Primary Outcome Measures :
  1. Total systemic corticosteroid dose use [ Time Frame: 52 weeks ]
    Dose of systemic corticosteroids. Reduction in the use of systemic corticosteroids


Secondary Outcome Measures :
  1. Daytime and nighttime symptoms [ Time Frame: 52 weeks ]
    Change from baseline in daytime and nighttime symptoms using an electronic diary. The diary consists of 5 questions regarding daytime and nocturnal asthma symptom

  2. Asthma Control Questionaire (ACQ-5) [ Time Frame: 52 weeks ]
    Change from baseline in Asthma Control Questionnaire total score. The ACQ-5 consists of 5 questions on a 7-point scale (0=no impairment, 6=maximum impairment).

  3. Asthma Related Quality of Life Questionnaire (AQLQ+12) [ Time Frame: 52 weeks ]
    Change from baseline in Asthma Related Quality of Life Questionnaire total score. AQLQ+12 consists of 32 questions each scaled from 1 to 7, where 1 indicates maximal impairment and 7 indicates no impairment

  4. Continoulsy systemic corticosteroid dose use [ Time Frame: 52 weeks ]
    Proportion of patients requiring ≥ 7.5mg systemic corticosteroid dose in mg per day continuously for at least 30 days

  5. No systemic corticosteroid use [ Time Frame: 52 weeks ]
    Proportion of patients with no systemic corticosteroid use

  6. Biologic therapy [ Time Frame: 52 weeks ]
    Time to first prescription of biologic therapy from first dose of study treatment received



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.LAMA, 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 is 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 enrolment

Exclusion Criteria:

  • Asthma exacerbation, within 6 weeks prior to enrolment (screening) that required SCS, hospitalization, or emergency room visit.
  • Chronic/ maintenance use of 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 contra-indications 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

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): NCT03629249


Contacts
Layout table for location contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
Show Show 70 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals

Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03629249    
Other Study ID Numbers: CQAW039A2323
2018-000212-25 ( EudraCT Number )
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Lung Diseases
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Hypersensitivity
Hypersensitivity
Hypersensitivity, Immediate
Respiratory Tract Diseases
Immune System Diseases
Indoleacetic Acids
Plant Growth Regulators
Growth Substances
Physiological Effects of Drugs