ncontrolled asthma with medium or high-dose ICS/LABA

Not Applicable

Completed

• Conditions: Asthma

• Registration Number: JPRN-jRCT1080225279
• Lead Sponsor: ovartis Pharma K.K.

Brief Summary

Overall, 454 patients were included into the study from 18 sites across Japan. For the primary endpoint based on the JGL 2018 criteria, 244 (53.7%) of the patients reported their asthma as uncontrolled at Visit 1 and/or Visit 2. The proportions of patients with uncontrolled asthma at Visit 1 and/or Visit 2 were lower (165 [36.3%] patients) when evaluating the primary endpoint based on the GINA 2019 criteria compared with the JGL 2018 criteria.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-16
• Study Completion: 2022-01-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 454

Inclusion Criteria

1) Written informed consent must be obtained before study entry.
2) Male and female adult patients 20 to 75 years of age at the time of enrollment.
3) Patients with a documented physician diagnosis of asthma for >=1 year prior to the enrollment.
4) Patients who have been prescribed with medium or high dose ICS/LABA for >=3 months and a stable dose of ICS/LABA for >=1 month with or without other controllers (e.g., leukotriene receptor antagonist [LTRA], LAMA, theophylline, OCS) prior to the enrollment
5) Past medical history is available

Exclusion Criteria

1) Patients who have used any biologics (e.g., omalizumab, mepolizumab, benralizumab, dupilumab) within 4 months before the study entry.
2) Patients who are treated with single inhaler maintenance and reliever therapy (SMART); use of budesonide (BUD)/formoterol fumarate (FM) as a controller is allowed.
3) Patients with chronic lung diseases other than asthma including (but not limited to) chronic obstructive pulmonary disease (COPD), sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
4) Patients who had a severe exacerbation within 1 month before enrollment; severe exacerbation is aggravation of asthma symptoms requiring systemic corticosteroids for at least three consecutive days and/or need for an ER visit or hospitalization due to asthma, based on the definition by European Respiratory Society (ERS)/American Thoracic Society (ATS) guidelines.

Study & Design

• Study Type: Observational
• Study Design: Not specified