Moderate-to-severe, persistent asthma, inadequately controlled with ICS therapy. MedDRA version: 17.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent must be obtained before any assessment is performed 2. Males and females of any race who are aged =18 years 3. Patients with a diagnosis of persistent asthma (according to GINA2011) for a period of at least 6 months prior to screening 4. Patients with a pre-bronchodilator FEV1 value of 40% to 80% of individual predicted value at screening and prior to treatment. The FEV1 results should meet the ATS/ERS criteria for acceptability and repeatability (in case of screening failure due to ATS/ERS criteria, rescreening is allowed once) 5. Patients must be either non-atopic as defined by: a. A history of perennial symptoms with no clear inhaled allergic trigger AND b. A negative skin prick test (=65 years) yes F.1.3.1 Number of subjects for this age range 110
Exclusion criteria
Exclusion criteria: 1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer 2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (CRTH2 antagonists) 3. History of long QT syndrome or whose current QTc measured at runin (Fridericia’s) is prolonged > 450 msec for males and females and confirmed by a central assessor 4. Pregnant or nursing (lactating) women 5. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment 6. Acute illness other than asthma at the start of the study 7. History of life-threatening asthma, including a history of significant hypercarbia (pCO2>45mmHg), prior intubation, respiratory arrest, or seizures as a result of asthma 8. Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening 9. Patients who have a clinically significant abnormality on a 12 lead ECG recorded within one month prior to screening. Patients who have a clinically significant abnormality on a 12-lead ECG recorded at run-in 10. Patients with serious co-morbidities including, but not limited to, uncontrolled diabetes (HbA1c =8%), heart failure, cancer, neurodegenerative diseases, rheumatoid arthritis and other autoimmune diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the efficacy of QAW039 (450 mg qd) compared to placebo with respect to the change in trough FEV1 from baseline to 12 weeks of post-baseline treatment in non-atopic asthmatic patients who, at randomization, were inadequately controlled on low dose ICS (100 µg fluticasone BID) background therapy.;Secondary Objective: The key secondary objective is to demonstrate that QAW039 provides superior control of asthmatic symptoms to placebo in non-atopic asthmatic patients, as measured by the asthma control questionnaire (ACQ-6) Secondary Objectives: • To compare the efficacy of QAW039 as an add-on therapy to background ICS (100 µg fluticasone BID) with an increased dose of ICS (250 µg fluticasone BID) in inadequately controlled atopic asthmatics • To compare the efficacy of QAW039 as an add-on therapy to background ICS (100 µg fluticasone BID) between non-atopic and atopic asthmatic patients • To assess safety and tolerability of QAW039 in the non-atopic asthmatic population as compared to placebo For further secondary and exploratory objectives please see protocol section 2.;Primary end point(s): The primary objective of the study is to evaluate superiority of QAW039 over placebo (with low-dose ICS as the background therapy) for the non-atopic group. The primary efficacy variable is the change from baseline in trough FEV1 (24-hour post morning dose) measured. Trough is defined as the FEV1 measurement at 23 hr. 10 min post dose on the preceding day. The baseline FEV1 is defined as the FEV1 assessments taken in the clinic at Visit 202.;Timepoint(s) of evaluation of this end point: Visits 101, 102, 199 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary variables include the change from baseline in ACQ-6. The baseline is defined as the assessment measured at Visit 202 (Day 14), i.e. the first day of treatment period. For more details / other assessments please see protocol section 6.;Timepoint(s) of evaluation of this end point: visits 101, 102, 201 | — |
Countries
Belgium, Colombia, Czech Republic, Germany, India, Korea, Republic of, Poland, Romania, South Africa, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed