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An observational study of untreated asthma patients initiating ICS/LABA treatment in Japan

Patient perception and feeling of Asthma management in real world setting: An observational study of untreated asthma patients initiating ICS/LABA treatment in Japan - PITFALL study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT1030250201
Enrollment
450
Registered
2025-07-02
Start date
2025-08-04
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

Asthma

Interventions

None listed

Sponsors

Maruyama Atsushi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients aged >= 18 years at enrollment 2.Untreated asthma patients defined as newly diagnosed asthma or patients with asthma without any asthma treatments for at least 6 months prior to enrollment 3.Patients who meet the following criteria for mild or moderate persistent asthma as defined for untreated asthma by JGL2024 4.Patients who initiate the middle to high dose ICS/LABA treatmenteither on the day of enrollment or within 2 days prior to enrollment 5.Patients who gave informed consent on the website

Exclusion criteria

Exclusion criteria: 1.Patients who initiate ICS/LABA/LAMA treatment, including single inhaler triple therapy or multi-inhaler triple therapy at enrollment 2.Patients who are prescribed systemic corticosteroids at enrollment 3.Patients who have any respiratory infection episode within one month prior to enrollment 4.Patients who are diagnosed with chronic obstructive pulmonary disease (COPD) at enrollment

Design outcomes

Primary

MeasureTime frame
Odds ratio between the odds of poorly controlled (ACT total score < 23) patients in the cohort A(Patients with high symptom frequency ) and that in cohort B(Patients with low symptom frequency ) at week 4.

Secondary

MeasureTime frame
1.Odds ratio between the odds of poorly controlled (ACT total score 3) at week 4, 8 and 12 3.Mean of the AHQ-33 total score at enrollment, week 4, 8 and 12, and mean change in the AHQ-33 total score from enrollment at week 4, 8 and 12

Contacts

Public ContactYoichi Tamai

AstraZeneca K.K.

yoichi.tamai@astrazeneca.com+81-6-4802-3600

Outcome results

None listed

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