A Phase IV Clinical Trial of EMPYNASE P Tablets 18000 in Patients with Chronic Respiratory Disease.

A Phase IV Clinical Trial of EMPYNASE P Tablets 18000 in Patients with Chronic Respiratory Disease. - A Phase IV Clinical Trial of EMPYNASE P Tablets 18000 in Patients with Chronic Respiratory Disease.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008534

Enrollment

240

Registered

2012-07-25

Start date

2012-07-27

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

Patients with expectoration symptom in acute exacerbation of bronchial asthma or chronic obstructive pulmonary disease.

Interventions

EMPYNASE group EMPYNASE P Tablets are administrated orally after three meals for 2 weeks. Placebo group Placebos are administrated orally after three meals for 2 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients with asthma or COPD. -Patients who can be seen in outpatient department. -Patients who can be looked at historical data of FEV1 in stable condition. -50% <= %FEV1 < 80%. -Patients who has expectorate symptoms defined in this study. -Patients who can expectorate sputum by oneself.

Exclusion criteria

Exclusion criteria: -Patients with a history of drug hypersensitivity. -Patients with blood clotting defect. -Elderly patients with depressed physiological function and who are judged to be inadequate to participate in this trial by the principal investigator or co-investigator. -Patients who are needed domiciliary oxygen therapy. -Patients whose general status are quite worsened.

Design outcomes

Primary

Measure	Time frame
Changing rate of FEV1	—

Countries

Japan

Contacts

Public ContactFuminori Kobayashi

Kaken Pharmaceutical Co., LTD. Clinical Development Department

kobayashi_fuminori@kaken.co.jp03-5977-5111

Outcome results

None listed

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