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Study of Efficacy and Safety of QAW039 in Patients With Severe Asthma Inadequately Controlled With Standard of Care Asthma Treatment.

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ClinicalTrials.gov Identifier: NCT02555683
Recruitment Status : Recruiting
First Posted : September 21, 2015
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study aims to determine the efficacy and safety of QAW039 (Dose 1 and Dose 2), compared with placebo, when added to GINA steps 4 and 5 standard-of- care (SoC) asthma therapy (GINA 2015) in each of the groups (patients with severe asthma and high eosinophil counts and all patients with severe asthma).

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

Detailed Description:
A double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (Dose 1 and Dose 2) of QAW039 compared with placebo over a 52-week treatment period in in each of the groups (patients with severe asthma and high eosinophil counts and all patients with severe asthma). Efficacy will be measured by the rate of asthma exacerbations. In addition, asthma quality of life score, asthma control score and lung function will be assessed. Safety will be assessed by adverse event monitoring.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 846 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of QAW039 When Added to Existing Asthma Therapy in Patients With Uncontrolled Severe Asthma.
Actual Study Start Date : December 11, 2015
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : December 20, 2019

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
QAW039 Dose 1 once daily

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

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




Primary Outcome Measures :
  1. Moderate-to-severe asthma exacerbations [ Time Frame: 52 weeks ]

    Reduction in the rate of moderate-to-severe asthma exacerbations. A severe asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and hospitalization; or treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days and emergency department visit (greater than 24 hours*); or death due to asthma.

    A moderate asthma exacerbation is defined as treatment with 'rescue' systemic corticosteroids for greater than or equal to 3 days either as an outpatient or in emergency department visits (Emergency department visit less than or equal to 24 hours).



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

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

  3. Pre-dose Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 52 weeks ]
    Change from baseline in pre-dose FEV1 (liters).

  4. Safety (Incidence of Treatment-Emergent Adverse Events) [ Time Frame: 52 weeks ]
    Adverse event monitoring.



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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:

  • Written informed consent and assent (if applicable).
  • Male and female patients aged ≥12 years (or ≥lower age limit allowed by health authority and/or ethics committee/institutional review board approvals).
  • A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.
  • Evidence of airway reversibility or airway hyper- reactivity.
  • FEV1 of ≤80% of the predicted normal value for patients aged ≥18 years; FEV1 of ≤90% for patients aged 12 to <18 years
  • An ACQ score ≥1.5.
  • A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.

Exclusion Criteria:

  • 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.
  • 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, greater than 40 mg of atorvastatin, greater than 40 mg of pravastatin, or greater than 2 mg of pitavastatin

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): NCT02555683


Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111

  Show 256 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02555683     History of Changes
Other Study ID Numbers: CQAW039A2307
2015-002553-35 ( EudraCT Number )
First Posted: September 21, 2015    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Asthma
QAW039

Additional relevant MeSH terms:
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