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Comparison of the effect of tiotropium monotherapy versus tiotropium and indacaterol combination therapy in patients with chronic obstructive pulmonary disease

Comparison of the effect of tiotropium monotherapy versus tiotropium and indacaterol combination therapy in patients with chronic obstructive pulmonary disease - Comparison of the effect of tiotropium monotherapy versus tiotropium and indacaterol combination therapy in patients with chronic obstructive pulmonary disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009077
Enrollment
60
Registered
2012-10-10
Start date
2012-10-01
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

Chronic obstructive pulmonary disease (COPD)

Interventions

5 microgram once daily tiotropium 5 microgram once daily tiotropium and 150 microgram once daily indacaterol

Sponsors

Department of Respiratory Medicine, Chiba-Hokusoh Hospital, Nippon Medical School
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patient who is outpatient of Chiba-Hokusoh Hospital is able to read and understand the Informed Consent Form and he/she will sign the Informed Consent. 2. COPD patient, over 40 years, meets all of the following inclusion criteria. Current or former smokers. FEV1/FVC level is within 70% after 15 minutes used the bate 2 agonist on respiratory function test .

Exclusion criteria

Exclusion criteria: 1. Patient who has an anamnesis of hypersensitivity to the medicine used by this research . 2. Patient of the symptom that bronchial asthma is main. 3. Patient who has already used LABA other than indacaterol. The patient who is using other LABA presupposes that participation is possible, when the wash out period for four weeks or more is prepared before a start. 4. A glaucomatous patient 5. Patient with the urination trouble by prostatic hypertrophy. 6. Patient who was considered ineligible by the investigators.

Design outcomes

Primary

MeasureTime frame
1(The add-on effects of the combined therapy on FEV1 in patients with COPD. 2) CAT (COPD Assessment Test) score and modified medical research council score

Secondary

MeasureTime frame
Airway resistance (R5, R20, R5-R20) Change of HADS (Hospital Anxiety and Depression Scale) Change of Rint (Interrupter airway resistance) Safety

Countries

Japan

Contacts

Public ContactYosuke Tanaka

Chiba-Hokusoh Hospital, Nippon Medical School Department of Respiratory Medicine

yosuke-t@nms.ac.jp0476-99-1961

Outcome results

None listed

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