Efficacy of Indacaterol 150 µg Versus Formoterol

A 12-week Treatment, Multicenter, Randomized, Double Blind, Double Dummy, Parallel-group Study to Assess the Efficacy of Indacaterol (150 μg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 μg b.i.d.) as an Active Control

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01377428

Enrollment

Registered

2011-06-21

Start date

2011-09-30

Completion date

2012-02-29

Last updated

2017-04-20

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)

Keywords

COPD, Indacaterol, Formoterol

Brief summary

The study will be a 12 week treatment (84 days), parallel group, randomized, double blind, double dummy, study to assess the superiority of indacaterol (150 μg o.d.) versus formoterol (12 μg b.i.d.) in terms of trough forced expiratory volume in 1 second (FEV1). Patients will be enrolled after giving informed consent and then begin a screening/run-in period for 14 days. Patients will be randomized to one of two treatment groups using an allocation ratio of 1:1 to receive either indacaterol (150 μg o.d.) and placebo to formoterol, or formoterol (12 μg b.i.d.) and placebo to indacaterol for a treatment period of 12 weeks.

Interventions

DRUGIndacaterol

Indacaterol 150 µg once daily (od) via single-dose dry powder inhaler (SDDPI)

DRUGFormoterol

Formoterol 12 µg twice daily (bid) via single-dose dry powder inhaler (SDDPI)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009) and: * Post-bronchodilator FEV1 \<80% and ≥40% of the predicted normal value * Post-bronchodilator FEV1/FVC (forced vital capacity) \<70% * Smoking history of at least 10 pack-years

Exclusion criteria

* Patients who have had a COPD exacerbation in the 6 weeks prior to screening * Patients who have had a respiratory tract infection within 6 weeks prior to screening * Patients with concomitant pulmonary disease * Patients with a history of asthma * Patients with diabetes Type I or uncontrolled diabetes Type II * Any patient with lung cancer or a history of lung cancer * Patients with a history of certain cardiovascular comorbid conditions Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
24-h post-dose trough forced expiratory volume in 1 second (FEV1)	After 84 days of treatment

Secondary

Measure	Time frame
24-h post-dose trough inspiratory capacity (IC)	After 84 days of treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026