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

NCT01377051 | Completed Phase 4 DMC

• 1 other identifier: 654CEC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Lung Diseases; Dyspnea; Hypoxemia; Tachycardia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Intra Thoracic Gas Volume (ITGV)

  A complete body plethysmografic test will be performed after indacaterol inhalation

  60 minutes after drug inhalation

Secondary Outcomes (2)

• Forced Expired Volume in the first second (FEV1)

  60 minutes after drug inhalation

• Partial pressure of arterial oxygen (PaO2)

  60 minutes after drug inhalation

Study Arms (2)

Bronchodilator

ACTIVE COMPARATOR

Indacaterol maleate 300 mcg will be administered by a third independent investigator following a randomization list.

Drug: Indacaterol maleate

Placebo

PLACEBO COMPARATOR

Will be administered with the same device by a third independent investigator

Drug: Placebo

Interventions

Indacaterol maleate DRUG

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

Also known as: Onbrez, Hirobriz, Onbrize, Oslif Breezehaler, Arcapta

Bronchodilator

Placebo DRUG

Dry powered, same to study drug, only one inhalation

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead
• Fondazione Salvatore Maugeri: collaborator

Study Sites (1)

Pneumologia Riabilitativa - Fondazione Maugeri - Istituto Scientifico di Milano - IRCCS

Milan, 20138, Italy

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases; Dyspnea; Hypoxia; Tachycardia

Interventions

indacaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease

Study Officials

• Pierachille Santus, MD, PhD

  Università degli Studi di Milano-Pneumologia Riabilitativa- Fondazione Maugeri-Istituto Scientifico di Milano-IRCCS - pierachille.santus@unimi.it

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 15, 2011
• First Posted: June 20, 2011
• Study Start: May 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 29, 2014

Record last verified: 2014-10

Locations

IT (1)