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

October 28, 2014 updated by: Pierachille Santus, University of Milan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20138
        • Pneumologia Riabilitativa - Fondazione Maugeri - Istituto Scientifico di Milano - IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Bronchodilator
Indacaterol maleate 300 mcg will be administered by a third independent investigator following a randomization list.
Drug: Indacaterol maleate
Dry powered, 300 mcg, only one inhalation with 24 hours duration
Other Names:
  • Onbrez, Hirobriz, Onbrize, Oslif Breezehaler, Arcapta
PLACEBO_COMPARATOR: Placebo
Will be administered with the same device by a third independent investigator
Drug: Placebo
Dry powered, same to study drug, only one inhalation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Expired Volume in the first second (FEV1)
Time Frame: 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).
60 minutes after drug inhalation
Partial pressure of arterial oxygen (PaO2)
Time Frame: 60 minutes after drug inhalation
Arterial gas analysis will be performed evaluating all arterial gases
60 minutes after drug inhalation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Collaborators

Fondazione Salvatore Maugeri

Investigators

  • Study Director: Pierachille Santus, MD, PhD, Università degli Studi di Milano-Pneumologia Riabilitativa- Fondazione Maugeri-Istituto Scientifico di Milano-IRCCS - pierachille.santus@unimi.it

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

June 15, 2011

First Submitted That Met QC Criteria

June 17, 2011

First Posted (ESTIMATE)

June 20, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

October 29, 2014

Last Update Submitted That Met QC Criteria

October 28, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 654CEC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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