The add-on effect of Tiotropium bromide to ICS/LABA combination inhaler for the patients with severe uncontrolled asthma

The add-on effect of Tiotropium bromide to ICS/LABA combination inhaler for the patients with severe uncontrolled asthma - Add-on effect of TIO for severe asthmatics

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019964

Enrollment

Registered

2015-11-28

Start date

2014-11-20

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 bromide once daily two puffs 6 months treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Poorly controlled moderate to severe asthmatics followed at our hospital, aged 20-80 years old, receiving Tiotropium Respimat(TIO) 2puffs/day for more than 6 months even with GINA step 4 or 5 standard treatment as described below; ICS/LABA combination (equivalent FP 1000microgram/day or more; i.e. Salmeterol/Fluticasone (SFC) 500 DPI twice daily, SFC 250 pMDI 4puffs/ day, or budesonide/formoterol (FBC) 160/4.5 8puffs/day or frequent SMART treatment) with other controller drugs.

Exclusion criteria

Exclusion criteria: apparent COPD patient

Design outcomes

Primary

Measure	Time frame
add-on improvement of respiratory resistance and reactance measured by Mostgraph-01 after inhalation of TIO or salbutamol to usual treatment with ICS/LABA combination after 6 months treatment period.	—

Secondary

Measure	Time frame
ACT scores, FeNO values, and spirometry values were also compared before and after 6 months treatment with TIO treatment.	—

Countries

Japan

Contacts

Public ContactMasayuki Hojo

National Center for Global Health and Medicine Division of Respiratory Medicine

mhojo@hosp.ncgm.go.jp03-3202-7181

Outcome results

None listed

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