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

Phase 4

Completed

• Conditions: COPD; Dyspnea; Hypoxemia; Lung Diseases; Tachycardia
• Interventions: Drug: Indacaterol maleate; Drug: Placebo

• Registration Number: NCT01377051
• Lead Sponsor: University of Milan

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-15
• Study First Submitted QC: 2011-06-17
• Study First Posted: 2011-06-20
• Primary Completion: 2011-08
• Study Completion: 2011-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-28
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bronchodilator	Indacaterol maleate	Indacaterol maleate 300 mcg will be administered by a third independent investigator following a randomization list.
Placebo	Placebo	Will be administered with the same device by a third independent investigator

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pneumologia Riabilitativa - Fondazione Maugeri - Istituto Scientifico di Milano - IRCCS; 🇮🇹 Milano, Italy