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

Primary Purpose

COPD, Lung Diseases, Dyspnea

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Indacaterol maleate
Placebo
Sponsored by
University of Milan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, Inspiratory capacity, Residual volume, Total lung resistance, Arterial Oxygen

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bronchodilator

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Intra Thoracic Gas Volume (ITGV)
A complete body plethysmografic test will be performed after indacaterol inhalation

Secondary Outcome Measures

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).
Partial pressure of arterial oxygen (PaO2)
Arterial gas analysis will be performed evaluating all arterial gases

Full Information

First Posted
June 15, 2011
Last Updated
October 28, 2014
Sponsor
University of Milan
Collaborators
Fondazione Salvatore Maugeri
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1. Study Identification

Unique Protocol Identification Number
NCT01377051
Brief Title
Effect of Indacaterol Maleate in Chronic Obstructive Pulmonary Disease (COPD) on Lung Volume and Related Dyspnea
Official Title
Acute Effect of Indacaterol Maleate on Static and Dynamic Lung Volume in COPD Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan
Collaborators
Fondazione Salvatore Maugeri

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Lung Diseases, Dyspnea, Hypoxemia, Tachycardia
Keywords
COPD, Inspiratory capacity, Residual volume, Total lung resistance, Arterial Oxygen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bronchodilator
Arm Type
Active Comparator
Arm Description
Indacaterol maleate 300 mcg will be administered by a third independent investigator following a randomization list.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Will be administered with the same device by a third independent investigator
Intervention Type
Drug
Intervention Name(s)
Indacaterol maleate
Other Intervention Name(s)
Onbrez, Hirobriz, Onbrize, Oslif Breezehaler, Arcapta
Intervention Description
Dry powered, 300 mcg, only one inhalation with 24 hours duration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dry powered, same to study drug, only one inhalation
Primary Outcome Measure Information:
Title
Intra Thoracic Gas Volume (ITGV)
Description
A complete body plethysmografic test will be performed after indacaterol inhalation
Time Frame
60 minutes after drug inhalation
Secondary Outcome Measure Information:
Title
Forced Expired Volume in the first second (FEV1)
Description
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).
Time Frame
60 minutes after drug inhalation
Title
Partial pressure of arterial oxygen (PaO2)
Description
Arterial gas analysis will be performed evaluating all arterial gases
Time Frame
60 minutes after drug inhalation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierachille Santus, MD, PhD
Organizational Affiliation
Università degli Studi di Milano-Pneumologia Riabilitativa- Fondazione Maugeri-Istituto Scientifico di Milano-IRCCS - pierachille.santus@unimi.it
Official's Role
Study Director
Facility Information:
Facility Name
Pneumologia Riabilitativa - Fondazione Maugeri - Istituto Scientifico di Milano - IRCCS
City
Milano
ZIP/Postal Code
20138
Country
Italy

12. IPD Sharing Statement

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

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