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Clinical characteristics of uncontrolled asthmatic patients improved by single-inhaler triple therapy

Clinical characteristics of uncontrolled asthmatic patients improved by single-inhaler triple therapy - Clinical characteristics of uncontrolled asthmatic patients improved by single-inhaler triple therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046167
Enrollment
30
Registered
2021-12-01
Start date
2021-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial asthma

Interventions

single-inhaler triple therapy for 12 weeks

Sponsors

Department of Respiratory Medicine, Tohoku Rosai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients of both sexes aged 20 years and older 2) Patients with a diagnosis of asthma or cough variant asthma who have been receiving ICS or ICS/LABA for at least four weeks before they participate in the study, and with an ACQ-6 score of at least 1.5 at the screening 3) Patients who signed informed consent form before enrolling the study

Exclusion criteria

Exclusion criteria: 1) Patients with malignant tumor 2) Patients with COPD or patients with a smoking history of 10 pack-years or more 3) Patients with a smoking history in last 6 months 4) Patients with benign prostatic hypertrophy or glaucoma 5) Any patients considered to be inappropriate for this study by the principal investigator based on their background, physical examination, etc.

Design outcomes

Primary

MeasureTime frame
The comparison of clinical characteristics between the group of uncontrolled asthma improved at least 0.5 point from the baseline ACQ-7 by single-inhaler triple therapy and the group without effect (baseline %FE1, FeNO, exacerbation frequency, peripheral blood eosinophil count, and so on)

Secondary

MeasureTime frame
1)Proportion of patients with at least 0.5 decrease in ACQ-7 score 2)Adverse event

Countries

Japan

Contacts

Public ContactToshiyasu Yatsu

Tohoku Rosai Hospital Department of Respiratory Medicine

yatsu822009@yahoo.co.jp0222751111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026