A randomized, multi center, parallel group, double-blind, placebo and formoterol controlled 14 day dose ranging trial 4 doses of indacaterol delivered via Twisthaler®, in patients with COPD.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003189-16-IE

Enrollment

558

Registered

2007-07-13

Start date

2007-09-07

Completion date

Unknown

Last updated

2012-05-01

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) MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD

Interventions

Product Name: Indacaterol Twisthaler Pharmaceutical Form: Inhalation powder Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 62.5- Pharmaceutical form of the placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Male and female adults aged =40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure (which include any adjustment to their current COPD treatment – see Section 6.6.5.5.) -Cooperative outpatients with a diagnosis of COPD (moderate to severe as classified by the GOLD Guidelines, 2006) and: a) Smoking history of at least 10 pack years b) Post-bronchodilator FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using acceptable methods of contraception. -Patients who have been hospitalized for an exacerbation of their airways disease within 6 weeks prior to Visit 1 or between Visit 1 and Visit 2. -Patients with a history of asthma. -Patients with an acute respiratory tract infection within 4 weeks prior to Visit 1, will be not allowed to enter the study. -Other clinically significant conditions which may interfere with the study conduct or patient safety as specified in the protocol.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Trough FEV1 assessed as mean change from baseline to 24 hr post dose (trough) FEV1 after 14 days of treatment.;Main Objective: 125, 250, and 500 µg o.d.) and placebo as measured by the mean change from baseline to 24 hr post-dose (trough) FEV1 after 14 days of treatment. (Baseline FEV1 is defined as the average of two FEV1 assessments taken at 50 min and 15 min before the first study drug administration. Trough FEV1 is defined as the mean of 2 measurements at 23 hr 10 min and 23 hr 45 min post-dose).;Secondary Objective: -Efficacy To assess the bronchodilator effect of four doses of indacaterol Twisthaler® at 62.5, 125, 250, and 500 µg o.d. in patients with COPD compared to placebo To estimate the effects of treatment with formoterol (12 µg b.i.d.) and placebo for all of the efficacy variables above - Safety To assess the safety of multiple doses of indacaterol Twisthaler® in patients with COPD by comparing four doses (62.5, 125, 250, and 500 µg o.d.) in comparison to placebo in terms of the number and percentage of adverse events, laboratory analysis, vital signs (blood pressure and pulse rate) and ECGs. To assess the safety of formoterol (12 µg b.i.d) in comparison to placebo, in terms of the number and percentage of adverse events, laboratory analysis, vital signs (blood pressure and pulse rate) and ECG.	—

Measure

Time frame

Primary end point(s): Trough FEV1 assessed as mean change from baseline to 24 hr post dose (trough) FEV1 after 14 days of treatment.;Main Objective: 125, 250, and 500 µg o.d.) and placebo as measured by the mean change from baseline to 24 hr post-dose (trough) FEV1 after 14 days of treatment. (Baseline FEV1 is defined as the average of two FEV1 assessments taken at 50 min and 15 min before the first study drug administration. Trough FEV1 is defined as the mean of 2 measurements at 23 hr 10 min and 23 hr 45 min post-dose).;Secondary Objective: -Efficacy To assess the bronchodilator effect of four doses of indacaterol Twisthaler® at 62.5, 125, 250, and 500 µg o.d. in patients with COPD compared to placebo To estimate the effects of treatment with formoterol (12 µg b.i.d.) and placebo for all of the efficacy variables above - Safety To assess the safety of multiple doses of indacaterol Twisthaler® in patients with COPD by comparing four doses (62.5, 125, 250, and 500 µg o.d.) in comparison to placebo in terms of the number and percentage of adverse events, laboratory analysis, vital signs (blood pressure and pulse rate) and ECGs. To assess the safety of formoterol (12 µg b.i.d) in comparison to placebo, in terms of the number and percentage of adverse events, laboratory analysis, vital signs (blood pressure and pulse rate) and ECG.

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Countries

France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, United Kingdom

Outcome results

None listed

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