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The clinical study of the budesonide/formoterol combination drug additional dosage in the perioperative period in a lung cancer patient with COPD.

The clinical study of the budesonide/formoterol combination drug additional dosage in the perioperative period in a lung cancer patient with COPD. - The clinical study of the budesonide/formoterol combination drug additional dosage in the perioperative period in a lung cancer patient with COPD.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011462
Enrollment
40
Registered
2013-08-12
Start date
2013-08-26
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

Non-small cell lung cancer patients with COPD.

Interventions

Tiotropium 18&amp
#13197
once daily for 13 weeks. Tiotropium 18&amp
once daily with budesonide / formoterol combination drug 2 inhalation twice a day (morning and night time ) for 13 weeks.

Sponsors

Hamamatsu University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Age is full 20 or older-year patients at the time of agreement acquisition. 2) The patient of a perioperative period whom the examination doctor in charge diagnosed as lung cancer based on lung cancer handling agreement (the 7th edition) 3) The patient whom COPD diagnosis and a treatment guideline machine companion examination doctor in charge diagnosed as COPD 4) The patient who used tiotropium more than four week for COPD treatment. 5)Patients who agreed to participate in the study and signed informed consent form.

Exclusion criteria

Exclusion criteria: 1)Patient that there is ICS/LABA mixing medicine in pre-administering within four weeks 2)Patient where exacerbation of COPD was admitted within four weeks 3)Patient that there is past of hypersensitivity in atropine, the kind edge material or tiotropium, budesonide or formoterol 4)Patient who has chronic ailments of lungs, heart, kidney, liver, and blood, etc. 5)Patient who has previous history of adrenal cortical insufficiency or accentuation syndrome 6)Patient who has glaucoma 7)Patient who has dysuria such as dysuria by enlarged prostate 8)Case who judged doctor in charge targets and it is improper

Design outcomes

Primary

MeasureTime frame
Exacerbation rate of 12 weeks after the operation. (The extension of hospitalization, the infectious disease or the additional dosage of the antibiotic and administering a systemic steroid and the decrease in the respiratory function; The sum total of each event that falls below the predictive value by 10% or more at the time of 12 of the week of after the operation is divided in the population).

Countries

Japan

Contacts

Public ContactKazuhito Funai

Hamamatsu University School of Medicine Surgery 1

kfunai@hama-med.ac.jp053-435-2276

Outcome results

None listed

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