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Study for effects of tiotropium on smokers and non-smokers with bronchial asthma

Study for effects of tiotropium on smokers and non-smokers with bronchial asthma - Tiotropium on smokers and non-smokers with asthma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010352
Enrollment
20
Registered
2013-03-29
Start date
2013-04-10
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

1) single inhalation of tiotorpium 2) wash out period (3 to 5 weeks) 3) single inhalation of placebo 1) single inhalation of placebo 2) wash out period (3 to 5 weeks) 3) single inhalation of tioto

Sponsors

Fukuoka National Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) subjects diagnosed with bronchial asthma 2) subjects treated with high dose inhaled corticosteroid 3) subjects who currently smoke 5 cigarettes per day with smoking history over 5 pack-years, or subjects with no smoking history

Exclusion criteria

Exclusion criteria: 1) subjects treated with oral corticosteroid 2) subjects treated with inhaled of oral anticholinergics 3) short acting beta2 agonists use within 6hours before visits 4) low attenuation area in lung fields on chest HTCT 5) decreased diffusion capasity in lung function tests 6) narrow angle glaucoma 7) benign prostate hypertrophy 8) heart failure, atrial fibrillation or premature beats 9) active infection of respiratory tract or history of pulmonary tuberculosis 10) history of lung surgery 11) allergy to oral or inhaled anticholinergics 12) difficult to perform pulmonary function tests 13) pregnancy or breast-feeding

Design outcomes

Primary

MeasureTime frame
Lung function tests (FVC, FEV1, PEFR, V50, V25) before and 1 hour, 3 hours and 24 hours after single inhalation of tiotropium

Secondary

MeasureTime frame
Blood pressure, heart rate and SpO2 before and 1 hour, 3hours and 24 hours after single inhala tion of tiotropium

Countries

Japan

Contacts

Public ContactMakoto Yoshida

Fukuoka National Hospital Division of Respiratory Medicine

myoshida@mfukuoka2.hosp.go.jp092-565-5534

Outcome results

None listed

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