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Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma Treatment

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: NCT03052517
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study is a 2-treatment period, randomized, multicenter parallel-group study. The overall purpose of this study is to provide long- term safety data for fevipiprant (QAW039) (Dose 1 and Dose 2), compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care (SoC) asthma therapy (GINA 2016), in patients with moderate-to- severe asthma.

Condition or disease Intervention/treatment Phase
Asthma Drug: QAW039 Dose 1 Drug: QAW039 Dose 2 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 2-treatment Period, Randomized, Placebo-controlled, Multicenter Parallel-group Study to Assess the Safety of QAW039 When Added to Existing Asthma Therapy in GINA Steps 3, 4 and 5 Patients With Uncontrolled Asthma.
Actual Study Start Date : March 21, 2017
Estimated Primary Completion Date : November 22, 2022
Estimated Study Completion Date : November 22, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: QAW039 Dose 1
QAW039 Dose 1 once daily
Drug: QAW039 Dose 1
QAW039 Dose 1 once daily

Experimental: QAW039 Dose 2
QAW039 Dose 2 once daily
Drug: QAW039 Dose 2
QAW039 Dose 2 once daily

Placebo Comparator: Placebo
Placebo once daily
Drug: Placebo
Placebo once daily




Primary Outcome Measures :
  1. treatment-emergent adverse events (AEs) [ Time Frame: 52 weeks ]
    Adverse events (AEs) starting on or after the time of the first intake of study drug and until the day after the last intake of study drug will be classified as treatment emergent AEs.

  2. treatment emergent serious adverse events [ Time Frame: 52 weeks ]
    Serious Adverse events starting on or after the time of the first intake of study drug and until the day after the last intake of study drug will be classified as treatment emergent SAEs.

  3. treatment emergent AEs leading to study treatment discontinuation [ Time Frame: 52 weeks ]
    Adverse events leading to study treatment discontinuation starting on or after the time of the first intake of study drug and until the day after the last intake of study drug will be classified as treatment emergent AEs leading to discontinuation.

  4. treatment-emergent adverse events (AEs) [ Time Frame: 160 weeks ]
    Adverse events (AEs) starting on or after the time of the first intake of study drug and until the day after the last intake of study drug will be classified as treatment emergent AEs.

  5. treatment emergent serious adverse events [ Time Frame: 160 weeks ]
    Serious Adverse events starting on or after the time of the first intake of study drug and until the day after the last intake of study drug will be classified as treatment emergent SAEs.

  6. treatment emergent AEs leading to study treatment discontinuation [ Time Frame: 160 weeks ]
    Adverse events leading to study treatment discontinuation starting on or after the time of the first intake of study drug and until the day after the last intake of study drug will be classified as treatment emergent AEs leading to discontinuation.


Secondary Outcome Measures :
  1. Rate of patients with at least 1 treatment emergent AE by primary system organ class [ Time Frame: 52 weeks ]
    The number of patients per patient year of follow-up having a treatment emergent adverse event, categorized by system organ class. Treatment emergent adverse events are defined as an AEs starting on or after the time of the first intake of study drug and until the day after the last intake of study drug

  2. Rate of treatment emergent patient deaths and patient hospitalizations due to an asthma exacerbation [ Time Frame: 52 weeks ]
    The number of treatment emergent patient deaths and patient hospitalizations (any visit to the hospital requiring an overnight stay or an emergency room visit greater than 24 hours) per patient year of follow-up due to an asthma exacerbation. Treatment emergent deaths are defined as an deaths occurring on or after the time of the first intake of study drug and until the day after the last intake of study drug. Treatment emergent hospitalizations are defined as hospitalizations occurring on or after the time of the first intake of study drug and until the day after the last intake of study drug.

  3. Rate of patients with at least 1 treatment emergent AE by primary system organ class [ Time Frame: 160 weeks ]
    The number of patients per patient year of follow-up having a treatment emergent adverse event, categorized by system organ class. Treatment emergent adverse events are defined as an AEs starting on or after the time of the first intake of study drug and until the day after the last intake of study drug

  4. Rate of treatment emergent patient deaths and patient hospitalizations due to an asthma exacerbation [ Time Frame: 160 weeks ]
    The number of treatment emergent patient deaths and patient hospitalizations (any visit to the hospital requiring an overnight stay or an emergency room visit greater than 24 hours) per patient year of follow-up due to an asthma exacerbation. Treatment emergent deaths are defined as an deaths occurring on or after the time of the first intake of study drug and until the day after the last intake of study drug. Treatment emergent hospitalizations are defined as hospitalizations occurring on or after the time of the first intake of study drug and until the day after the last intake of study drug.



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.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients completing a prior Phase 3 study of QAW039:

  • Informed consent and assent (if applicable).
  • Completion of the Treatment Period (on blinded study drug) of a prior Phase 3 study of QAW039.
  • Patient is able to safely continue into the study as judged by the investigator.

Patients who have not previously participated in a study of QAW039:

  • Written informed consent.
  • A diagnosis of asthma,uncontrolled on GINA 3/4/5 asthma medication.
  • Evidence of airway reversibility or airway hyper- reactivity.
  • FEV1 of ≤85% of the predicted normal value.
  • An ACQ score ≥1.5 prior to entering the study.

Exclusion Criteria:

Patients completing a prior phase 3 study of QAW039:

  • Pregnant or nursing (lactating) women.
  • Women of child-bearing potential unless they are using basic methods of contraception during dosing of study drug
  • Patients who did not complete the Treatment Period on blinded study drug of the prior QAW039 study they participated in.
  • Inability to comply with all study requirements.
  • Patient who experienced a serious and drug-related AE in the prior QAW039 study they participated in.

Patients who have not previously participated in a study of QAW039:

  • Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.
  • Subjects who have participated in another trial of QAW039 (i.e.-the patient was randomized in another study).
  • A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female).
  • History of malignancy with the exception of local basal cell carcinoma of the skin
  • Pregnant or nursing (lactating) women.
  • Serious co-morbidities.
  • Patients on greater than 20 mg of simvastatin> 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin. Statin doses less than or equal to these doses as well as other statins will be permitted during the study.

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): NCT03052517


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

Locations
Show Show 376 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03052517    
Other Study ID Numbers: CQAW039A2315
2016-001560-11 ( EudraCT Number )
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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


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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, QAW039
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Indoleacetic Acids
Plant Growth Regulators
Growth Substances
Physiological Effects of Drugs