Effect of Indacaterol Maleate in Chronic Obstructive Pulmonary Disease (COPD) on Lung Volume and Related Dyspnea

Acute Effect of Indacaterol Maleate on Static and Dynamic Lung Volume in COPD Subjects.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01377051

Enrollment

Registered

2011-06-20

Start date

2011-05-31

Completion date

2011-09-30

Last updated

2014-10-29

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

Conditions

COPD, Dyspnea, Hypoxemia, Lung Diseases, Tachycardia

Keywords

COPD, Inspiratory capacity, Residual volume, Total lung resistance, Arterial Oxygen

Brief summary

The purpose of this study is to determine whether indacaterol maleate 300 micrograms (mcg) is effective in the acute treatment of COPD and in particular on reducing lung hyperinflation and dynamic volumes.

Detailed description

Enrolled patients: COPD of any disease severity in stable conditions. 48 hours of inhalatory drugs wash out. Evaluation: Plethysmographic test, blood gas analysis, blood pressure, cardiac frequency and Borg scale evaluation in basal condition and after 60 minutes of indacaterol maleate 300 mcg inhalation.

Interventions

DRUGIndacaterol maleate

Dry powered, 300 mcg, only one inhalation with 24 hours duration

DRUGPlacebo

Dry powered, same to study drug, only one inhalation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Signature of consensus * COPD diagnosis * Age from 50 to 85 years old * history of COPD at least of one year * respiratory stable conditions at least of one month * Any basal FEV1 expressed in % of predicted value * FEV1/ Forced Vital Capacity (FVC) less than 70% * Former or active smokers with at least a smoking history of 20 pack year

Exclusion criteria

* Pregnancy * FEV1/FVC more than 70% * Known deficit of alpha 1 antitrypsin * Subjects submitted to a Lung Volume Reduction Surgery (LVRS) * Subjects with known positivity to Human Immunodeficiency Virus (HIV) * Misuse of alcool or drugs * Absence of compliance in performing respiratory tests

Design outcomes

Primary

Measure	Time frame	Description
Intra Thoracic Gas Volume (ITGV)	60 minutes after drug inhalation	A complete body plethysmografic test will be performed after indacaterol inhalation

Secondary

Measure	Time frame	Description
Forced Expired Volume in the first second (FEV1)	60 minutes after drug inhalation	Will be performed: spirometry, Arterial blood sample, measurement of blood pressure and cardiac frequency. All these parameters will be tested 60 minutes after inhalation of Indacaterol 300 micrograms (mcg).
Partial pressure of arterial oxygen (PaO2)	60 minutes after drug inhalation	Arterial gas analysis will be performed evaluating all arterial gases

Countries

Italy

Outcome results

None listed

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