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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01377051
• Other study ID #: 654CEC
• Status: Completed
• Phase: Phase 4
• First received: June 15, 2011
• Last updated: October 28, 2014
• Start date: May 2011
• Est. completion date: September 2011

Study information

• Verified date: October 2014
• Source: University of Milan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Dyspnea
• Hypoxemia
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive
• Tachycardia

Intervention

Drug:
• Indacaterol maleate
Dry powered, 300 mcg, only one inhalation with 24 hours duration
• Placebo
Dry powered, same to study drug, only one inhalation

Locations

Country	Name	City	State
Italy	Pneumologia Riabilitativa - Fondazione Maugeri - Istituto Scientifico di Milano - IRCCS	Milano

Sponsors (2)

Lead Sponsor	Collaborator
University of Milan	Fondazione Salvatore Maugeri

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra Thoracic Gas Volume (ITGV)	A complete body plethysmografic test will be performed after indacaterol inhalation	60 minutes after drug inhalation	Yes
Secondary	Forced Expired Volume in the first second (FEV1)	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).	60 minutes after drug inhalation	Yes
Secondary	Partial pressure of arterial oxygen (PaO2)	Arterial gas analysis will be performed evaluating all arterial gases	60 minutes after drug inhalation	Yes