Effect of Indacaterol on Inspiratory Capacity and Lung Function in Patients With COPD Versus Placebo and Formoterol

An Exploratory, Double-Blind Comparison of Inspiratory Capacity (IC) and FEV1 in COPD Patients Following Single Dose Administration of Indacaterol and Placebo and Open Label b.i.d. Administration of Formoterol

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00422552

Enrollment

Registered

2007-01-17

Start date

2006-09-30

Completion date

Unknown

Last updated

2007-06-22

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

Conditions

COPD

Keywords

inspiratory capacity, FEV1, COPD

Brief summary

The purpose of this study is to assess the change in inspiratory capacity and lung function in patients with chronic obstructive pulmonary disease when treated with indacaterol compared to placebo and formoterol.

Interventions

DRUGIndacaterol (QAB149)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Male and post-menopausal female adults aged 40-80 years inclusive. * Patients with a clinical diagnosis of COPD according to the Global Initiative for Chronic Lung Disease (GOLD) Guidelines (2005) * Smoking history of at least 10 pack years (either smokers or ex-smokers). * Able to perform reproducible spirometry maneuvers. * Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.

Exclusion criteria

* COPD exacerbations within 6 weeks prior to dosing * Concomitant lung disease such as asthma, requirement for long term oxygen treatment or history of lung reduction surgery. * Medical conditions that would interfere with the performance of spirometry or may pose a potential hazard from performing spirometry. * Any other medical condition that in the opinion of the Investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study, e.g. uncontrolled hypertension, unstable ischemic heart disease. * Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations. Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Change from baseline in IC and percent predicted FEV1 at various timepoints over 24 hours	—

Secondary

Measure	Time frame
Percent predicted FEV1 time course change over 24 hours	—
Mean maximal change in IC time course change over 24 hours	—

Countries

United Kingdom

Outcome results

None listed

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