Full title of the trial : A randomized, double-blind, placebo-controlled, parallel group, multi-center, multiple dose (7 days) dose-ranging study, to assess the efficacy and safety of 4 doses of QAB149 (50, 100, 200 & 400 µg) delivered via a multiple dose inhaler and 1 dose of QAB149 (400 µg) delivered via a single dose inhaler in patients with chronic obstructive pulmonary disease (COPD). - Not applicable

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-000025-29-SE

Enrollment

660

Registered

2004-06-11

Start date

2004-08-10

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe Chronic Obstructive Pulmonary Disease Classification code 10010952

Interventions

Product Name: QAB149 Multi-dose Dry Powder Inhaler (MDDPI) Product Code: QAB149 Pharmaceutical Form: Inhalation powder INN or Proposed INN: Indacaterol CAS Number: 435273-74-8 Current Sponsor code: QA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male and female patients between 40 and 75 years with moderate to severe COPD. A smoking history of at least 20 pack years. FEV1 at visits 1 and 2 in the range =40% of the Quanjer predicted normal and =1.0L. Ratio of recorded FEV1 at visit 2 to recorded FEV1 at visit 1 must be >0.85 and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy, hospitalisation for an exacerbation in the 6 months prior to visit 1 or between visits 1 and 2, respiratory infection within 1 month prior to visit 1, concomitant pulmonary disease, history of asthma, seasonal or perennial allergic rhinitis, patients with QTc interval above 430ms (males) and 450ms (females).

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To explore other bronchodilatory efficacy measures as well as the safety and tolerability of the four MDDPI doses, and one SDDPI dose, of QAB149 following both 1 and 7 days of treatment. Pharmacokinetic parameters will also be evaluated.;Primary end point(s): FEV1 standardized area under the curve between 22 and 24 hours post-dosing on Day 1;Main Objective: To evaluate the bronchodilatory efficacy of QAB149 delivered via the MDDPI in patients with COPD	—

Measure

Time frame

Secondary Objective: To explore other bronchodilatory efficacy measures as well as the safety and tolerability of the four MDDPI doses, and one SDDPI dose, of QAB149 following both 1 and 7 days of treatment. Pharmacokinetic parameters will also be evaluated.;Primary end point(s): FEV1 standardized area under the curve between 22 and 24 hours post-dosing on Day 1;Main Objective: To evaluate the bronchodilatory efficacy of QAB149 delivered via the MDDPI in patients with COPD

—

Countries

Denmark, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026