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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/15/2021.

Study of Efficacy and Safety of LOU064 in Inadequately Controlled Asthma Patients

Clinicaltrials.gov identifier NCT03944707

Recruitment Status Terminated (Company decision)

First Posted May 9, 2019

Last update posted June 30, 2020

Study Description

Brief summary:

This is a non-confirmatory, multi-center, randomized, placebo-controlled, subject- and investigator-blinded, parallel-group study to evaluate the efficacy of LOU064 in patients with inadequately controlled asthma. All subjects will be randomized with 3:2 ratio to receive LOU064 experimental dose. or LOU064 matching placebo treatment for 12 weeks with standard background therapy of budesonide 80µg/formoterol 4.5µg two inhalations b.i.d.. This study will enroll approximately 75 subjects. The total duration for each subject in the study is approximately 20 weeks.

  • Condition or Disease:Asthma
  • Intervention/Treatment: Drug: LOU064 or placebo treatment
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 76 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: A Randomized, Subject- and Investigator-blinded, Placebo-controlled Study to Assess the Efficacy and Safety of LOU064 in Patients With Inadequately Controlled Asthma
  • Actual Study Start Date: July 2019
  • Actual Primary Completion Date: April 2020
  • Actual Study Completion Date: April 2020
Arms and interventions
Arm Intervention/treatment
Experimental: LOU064 treatment
45 subjects will be randomized to take LOU064 experimental dose
Drug: LOU064 or placebo treatment
all subjects will be randomized with ratio 3:2 on Day 1 to receive LOU064 or placebo dose for 12 weeks
Placebo Comparator: placebo group
30 subjects will be randomized to take LOU064 matching placebo
Drug: LOU064 or placebo treatment
all subjects will be randomized with ratio 3:2 on Day 1 to receive LOU064 or placebo dose for 12 weeks
Outcome Measures
  • Primary Outcome Measures: 1. pre-dose FEV1 [ Time Frame: from baseline to 12 weeks ]
    change from baseline in pre-dose FEV1 after 12 weeks of treatment with LOU064 experimental dose or placebo
  • Secondary Outcome Measures: 1. daytime and nighttime asthma symptom score [ Time Frame: from baseline to 12 weeks ]
    Change from baseline in daytime and nighttime asthma symptom score over 12 weeks of treatment
  • 2. Peak Expiratory Flow [ Time Frame: from baseline to 12 weeks ]
    change from baseline in PEF(AM and PM), as assessed by mean morning and mean evening PEF over 12 weeks of treatment
  • 3. number of puffs of SABA taken per day [ Time Frame: from baseline to 12 weeks ]
    number of puffs of SABA taken per day over 12 weeks of treatment
  • 4. Asthma Symptom Questionnaire-5 score [ Time Frame: from baseline to 12 weeks ]
    change from baseline in ACQ-5 over 12 weeks of treatment
  • 5. pharmacokinetic profile of LOU064 [ Time Frame: from predose to 12 weeks ]
    Concentrations of LOU064 in blood at steady state and calculation of Cmax
  • 6. Pharmacokinetic profile of LOU064 [ Time Frame: from predose to 12 weeks ]
    Concentrations of LOU064 in blood at steady state and calculation of Tmax
  • 7. Pharmacokinetic profile of LOU064 [ Time Frame: from predose to 12 weeks ]
    Concentrations of LOU064 in blood at steady state and calculation of AUC0-24h
Eligibility Criteria
  • Ages Eligible for Study: 18 to 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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) 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.

- History or current diagnosis of ECG abnormalities indicating significant risk of
safety for subjects participating in the study such as:

- Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular
tachycardia, and clinically significant second or third degree AV block without a
pacemaker

- History of familial long QT syndrome or known family history of Torsades de Pointes

- Resting heart rate (physical exam or 12 lead ECG) < 50 bpm at screening - Resting QTcF ≥ 450 msec (male) or ≥ 460 msec (female) at screening or inability to determine the QTcF interval - Use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of study - 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.

Contacts and Locations
Contacts
Locations
Show 19 Study Locations
Sponsors and Collaborators

Novartis Pharmaceuticals

More Information
  • Responsible Party: Novartis Pharmaceuticals
  • ClinicalTrials.gov Identifier: NCT03944707 History of Changes
  • Other Study ID Numbers: CLOU064D12201
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: June 30, 2020
  • Last Verified: June 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Asthma