Dose ranging study of indacaterol in Japanese patients with chronic obstructive pulmonary disease (COPD)

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220328

Enrollment

Registered

2006-12-05

Start date

2006-12-05

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

investigational material(s) Generic name etc : Indacaterol maleate INN of investigational material : Therapeutic category code : 225 Bronchodilators Dosage and Administration for Investigational mate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria - Male and female Japanese aged 40 to 75 years old - Moderate to severe COPD with smoking history of at least 20 pack years Exclusion criteria - History of hospitalization for COPD exacerbation within past 6 months - Use of long-term oxygen therapy - History of asthma - Respiratory tract infection within past 1 month - Consistently very high or low blood sugar - Clinically abnormal laboratory values or significant condition - History of heart failure or heart attack within past 6 months - History of long QT syndrome, or long QT interval in electrocardiogram recorded at screening Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Primary Outcomes: Lung function measured 22 to 24 hours after having taken medication, by a special test called "forced expiratory volume in 1 second" (FEV1) Secondary Outcomes: FEV1 at 5, 15 and 30min, 1, 2, 4, 8, and 12 hours post-dose; standardized FEV1 area under the curve (AUC) between 0-24hours post dose; Peak FEV1	—

Outcome results

None listed

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