Comparison of efficacy between long-acting muscarinic antagonist (LAMA) and leukotriene receptor antagonist (LTRA) as step-up treatment in patients with uncontrolled bronchial asthma

Comparison of efficacy between long-acting muscarinic antagonist (LAMA) and leukotriene receptor antagonist (LTRA) as step-up treatment in patients with uncontrolled bronchial asthma - Comparison of efficacy between LAMA and LTRA in uncontrolled asthma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022696

Enrollment

200

Registered

2016-06-11

Start date

2016-06-06

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

Tiotropium 2.5ug two inhalations, once daily for 12 weeks Montelukast 10mg oral administration, once daily for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with uncontrolled asthma under the treatment of moderate or high dose of ICS/LABA for over 4 weeks. They haven't treated with LAMA or LTRA for asthma.

Exclusion criteria

Exclusion criteria: (1) Treatment with oral or intravenous corticosteroids, hospitalization, emergency or unexpected visit within 4 weeks (2) Angle closure glaucoma, symptomatic prostatic hypertrophy and uncontrolled heart failure (3) Active other pulmonary diseases except for asthma and COPD (4) Vocal cord disfunction (5) Previous history of hypersensitivity to tiotropium or montelukast (6) Pregnancy or lactation (7) Considered to be unsuitable by the physicians

Design outcomes

Primary

Measure	Time frame
Change from baseline (0 week) in FEV1 after 12 weeks of treatment	—

Secondary

Measure	Time frame
Secondly end points are change in QOL (ACT score, ACQ score), parameters of pulmonary function (%FEV1, FEV1/FVC, PEF, MMF, respiratory resistance, respiratory reactance), and fractional exhaled nitric oxide after 12 weeks of treatment from baseline (0 week). Adverse events are reported throughout the study.	—

Countries

Japan

Contacts

Public ContactMitsuru Niwa

Hamamatsu University School of Medicine Second Division, Department of Internal Medicine

mtr.nw@hama-med.ac.jp053-435-2263

Outcome results

None listed

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