Inadequately controlled asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female adult patients aged = 18 to = 70 years at screening • Patients must weigh at least 40 kg to participate in the study, and must have a body mass index (BMI) =65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: • Patients who have had an asthma exacerbation requiring systemic corticosteroids, hospitalization, or emergency room visit within 6 weeks prior to screening or during the screening period. • Patients who have smoked or inhaled any substance other than asthma medications within the 6 month period prior to screening, or who have a smoking history of greater than 10 pack years (e.g. 10 pack years = 1 pack/day x 10 years or ½ pack/day x 20 years, etc.). • History of life-threatening asthma event such as significant hypercarbia (pCO2 > 45 mmHg), endotracheal intubation, non-invasive positive pressure ventilation (NIPPV), respiratory arrest, or seizure as a result of asthma. • Patients with chronic lung diseases other than asthma, including (but not limited to) chronic obstructive pulmonary disease, clinically significant bronchiectasis, sarcoidosis, interstitial lung disease, cystic fibrosis, Churg-Strauss syndrome, allergic broncho-pulmonary aspergillosis, or clinically significant chronic lung diseases related to a history of tuberculosis or asbestosis. • At screening and/or run-in period, any severe, progressive or uncontrolled, acute or chronic, medical or psychiatric condition, or other factors such as abnormal vital signs, ECG or physical findings, or clinically relevant abnormal laboratory values, that in the judgment of the investigator may increase the risk associated with study participation/treatment or may interfere with interpretation of study results, and thus would make the patient inappropriate for entry into or continuing the study. • Major surgery within 8 weeks prior to screening or surgery planned prior to end of study. • History of live attenuated vaccine within 6 weeks prior to randomization or requirement to receive vaccinations at any time during the study. • Hematology parameters at screening: • Hemoglobin: < 10 g/dl • Platelets: < 100 000/mm3 • White blood cells: < 3 000/mm3 • Neutrophils: < 1 500/mm3 • Significant bleeding risk or coagulation disorders. • History of gastrointestinal bleeding, e.g. in association with use of Nonsteroidal Anti-Inflammatory Drug (NSAID). • Requirement for anti-platelet or anticoagulant medication (e.g., warfarin, or clopidogrel or Novel Oral Anti-Coagulant - NOAC) other than acetylsalicylic acid (up to 100 mg/d). • History or presence of thrombotic or thromboembolic event, or increased risk for thrombotic or thromborembolic event.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the efficacy of LOU064 compared to placebo with respect to change from baseline in pre-dose FEV1 (L) at Week 12.;Secondary Objective: - To characterize the pharmacokinetic profile of LOU064 in blood of asthma patients - To determine the efficacy of LOU064 compared to placebo on changes in morning and evening peak expiratory flow rate (PEF) over the 12-week treatment period - To determine the efficacy of LOU064 compared to placebo on daytime and nighttime asthma symptom scores over the 12-week treatment period - To evaluate the safety and tolerability of LOU064 in patients with inadequately controlled Asthma - To determine the efficacy of LOU064 compared to placebo on change from baseline in Asthma Control Questionnaire-5 (ACQ-5) score over the 12-week treatment period For detailed list see full protocol - To determine the efficacy of LOU064 compared to placebo on total daily short-acting ß-agonist (SABA) used over the 12-week treatment period;Primary end point(s): Change from baseline in pre-dose FEV1 at Week 12;Timepoint(s) of evaluation of this end point: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Concentrations of LOU064 in blood at steady state and calculation of respective PK parameters including but not limited to Cmax, Tmax, AUC0-24h •Change from baseline in PEF (AM and PM), as assessed by mean morning and mean evening PEF over 12 weeks of treatment (captured in eDiary) •All safety endpoints (including vital signs, ECG intervals, safety laboratory parameters, adverse events, and serious adverse events) through the End of Study/Early Termination Visit •Change from baseline in daytime and nighttime asthma symptom score over 12 weeks of treatment (captured in eDiary) •Change from baseline in ACQ-5 score over 12 weeks of treatment (ACQ-assessment for the week preceding each planned visit up to End of Study) •Number of puffs of SABA taken per day over 12 weeks of treatment (captured in eDiary) ;Timepoint(s) of evaluation of this end point: week 1 to week 12 | — |
Countries
Argentina, China, Germany, Poland, Russian Federation, United States
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed