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An Open-label Crossover Trial to Explore the Clinical Effects and Safety of As-needed Use of ICS/LABA in Patients with Mild-intermittent Asthma

An Open-label Crossover Trial to Explore the Clinical Effects and Safety of As-needed Use of ICS/LABA in Patients with Mild-intermittent Asthma - Trial of As-needed use of ICS/LABA (TRAIL study)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016933
Enrollment
30
Registered
2015-04-01
Start date
2015-03-31
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

Patinets with mild-intermittent asthma

Interventions

As-nneded use of ICS/LABA standard treatment

Sponsors

Showa University, Department of Medicine, Division of Allergy and Respiratory Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Asthma diagnosed by allergist 1. Age is 20 to 80 years old at the time of obtaining informed consent 2. Being treated regularly more than a year 3. No asthma symptom in last 3 months before the enrollment 4. Being able to understand the as-needed use of ICS/LABA 5. Being able to obtain informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnant woman or woman who wish to be pregnant during the trial 2. Cough variant asthma 3. Current smoker or ex-smoker who smoked more than 10 pack-year 4. Complications with pulmonary diseases such as COPD and heart diseases 5. Admission within an year due to asthma attack 6. Participating in clinical trials 7. Being determined not to have indication for entry by physician

Design outcomes

Primary

MeasureTime frame
duration until the first excerbation

Secondary

MeasureTime frame
1. numbers of exacerbation 2. FEV1

Countries

Japan

Contacts

Public ContactAKIHIKO TANAKA

Showa University, Department of Medicine Division of Allergy and Respiratory Medicine, Department of Medicine

tanakaa@med.showa-u.ac.jp0337848532

Outcome results

None listed

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