STUDY OF SAFETY OF QAW039 IN PATIENTS WITH ASTHMA INADEQUATELY CONTROLLED ON STANDARD-OF-CARE ASTHMA TREATMENT.

Not Applicable

• Conditions: -J45; J45

• Registration Number: PER-023-18
• Lead Sponsor: OVARTIS BIOSCIENSES PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-19
• Study Completion: 2020-02-15
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 69

Inclusion Criteria

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

Exclusion Criteria

1. Patients who did not complete the Treatment Period on blinded study drug of the prior phase 3 study of QAW039 they participated in.
2. Inability to comply with all study requirements.
3. Patients who experienced a serious and drug-related AE in the prior phase 3 study of QAW039 they participated in

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Evaluation of serious and non-serious adverse events<br>Measure:Adverse events arising from treatment.<br>Timepoints:160 Weeks<br>;<br>Outcome name:Quantification of interruptions due to adverse events<br>Measure:Interruption of treatment due to adverse event<br>Timepoints:160 weeks<br>;<br>Outcome name:Quantification by classification by organs, devices and systems<br>Measure:Adverse event<br>Timepoints:160 weeks<br>;<br>Outcome name:Quantification of interruptions due to adverse events<br>Measure:Interruption of treatment due to adverse event<br>Timepoints:160 weeks<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Evaluation of adverse events<br>Measure:Rate of patients with at least 1 Adverse Event emerging from the treatment<br>Timepoints:160 weeks<br>;<br>Outcome name:Quantification by classification by organs, devices and systems<br>Measure:adverse events<br>Timepoints:160 weeks<br>;<br>Outcome name:Evaluation of deaths and hospitalizations<br>Measure:Rate of deaths and hospitalizations<br>Timepoints:160 Weeks<br>;<br>Outcome name:Quantification Deaths and hospitalizations during treatment due to an asthmatic exacerbation.<br>Measure:Deaths and hospitalizations during treatment due to an asthma exacerbation.<br>Timepoints:160 weeks<br>