Pulmonary Gas Exchange Response to Indacaterol in COPD

NCT02547558 | Unknown Phase 4

• 1 other identifier: IndaEPOC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the pulmonary gas exchange response to a therapeutic high dose of inhaled indacaterol (300 mcg) in 20 outpatients with stable symptomatic COPD B and D GOLD 2011 groups. Measurements on a single day before and after 60 and 120 minutes of indacaterol will include arterial PO2, PaCO2 and pH. AaPO2; SaO2 (by pulse oximetry) and oxygen and carbon dioxide in exhaled breath, systemic arterial pressure and heart rate will also be measured/calculated. Cardiac output will be directly measured by bio-impedance.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Indacaterol; Pulmonary gas exchange; Long-acting bronchodilators

Outcome Measures

Primary Outcomes (1)

• Change in PaO2 after indacaterol.

  60 and 120 minutes

Secondary Outcomes (4)

• Change in PaCO2 after indacaterol.

  60 and 120 minutes

• Change in D(A-a)DO2 after indacaterol.

  60 and 120 minutes

• Change in pH after indacaterol.

  60 and 120 minutes

• Change in cardiac output after indacaterol.

  60 and 120 minutes

Study Arms (1)

Indacaterol

EXPERIMENTAL

Drug: -Indacaterol, inhaled, single dose, 300 mcg Diagnostic Interventions: * Arterial blood gases * Cardiac output * Vital signs * Exhaled breath * Spirometry

Procedure: Arterial blood gases; Procedure: Cardiac Output; Procedure: Vital signs; Procedure: Exhaled breath; Procedure: Spirometry; Drug: Indacaterol

Interventions

Arterial blood gases PROCEDURE

Measured through radial arterial catheter

Also known as: PaO2, PaCO2, pH, AaPO2

Indacaterol

Cardiac Output PROCEDURE

Measured through bioimpedance: FloTrac pressure transducer (FloTrac sensor; Edwards Lifesciences) using the third-generation (3.01) FloTrac software for continuous CO display.

Also known as: CO

Indacaterol

Vital signs PROCEDURE

As measured in clinical practice

Also known as: Respiratory rate, Heart rate (HR), Systemic arterial pressure

Indacaterol

Exhaled breath PROCEDURE

Were recorded using a pneumotachograph (CPX/D; Med Graphics, St. Paul, MN, U.S.A.).

Also known as: Oxygen, Carbon dioxide

Indacaterol

Spirometry PROCEDURE

In a daily calibrated spirometer.

Also known as: FEV1, VFC

Indacaterol

Indacaterol DRUG

Indacaterol Breezhaler@ 300 mcg (1 inhalation)

Also known as: Ultra long acting beta 2 agonist

Indacaterol

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients with COPD diagnosis according to GOLD 2011 criteria (VEF1/CVF less than 70%), groups B and D.

You may not qualify if:

• Conditions or serious comorbidities (i.e., asthma, bronchiectasis, lung cancer and/or cardiovascular diseases).
• Patients with frequent exacerbations (2 or more exacerbations in the past year).
• History of acute COPD exacerbation in the previous 3 months.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic

Barcelona, 08036, Spain

Location

Related Publications (11)

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  PMID: 8681669 BACKGROUND

• Pillet O, Manier G, Castaing Y. Anticholinergic versus beta 2-agonist on gas exchange in COPD: a comparative study in 15 patients. Monaldi Arch Chest Dis. 1998 Feb;53(1):3-8.

  PMID: 9632900 BACKGROUND

• Whale CI, Sovani MP, Mortimer K, Oborne J, Cooper S, Harrison TW, Tattersfield AE. Effects of rac-albuterol on arterial blood gases in patients with stable hypercapnic chronic obstructive pulmonary disease. Br J Clin Pharmacol. 2006 Aug;62(2):153-7. doi: 10.1111/j.1365-2125.2006.02604.x.

  PMID: 16842389 BACKGROUND

• Kew KM, Mavergames C, Walters JA. Long-acting beta2-agonists for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2013 Oct 15;2013(10):CD010177. doi: 10.1002/14651858.CD010177.pub2.

  PMID: 24127118 BACKGROUND

• Kew KM, Dias S, Cates CJ. Long-acting inhaled therapy (beta-agonists, anticholinergics and steroids) for COPD: a network meta-analysis. Cochrane Database Syst Rev. 2014 Mar 26;2014(3):CD010844. doi: 10.1002/14651858.CD010844.pub2.

  PMID: 24671923 BACKGROUND

• Khoukaz G, Gross NJ. Effects of salmeterol on arterial blood gases in patients with stable chronic obstructive pulmonary disease. Comparison with albuterol and ipratropium. Am J Respir Crit Care Med. 1999 Sep;160(3):1028-30. doi: 10.1164/ajrccm.160.3.9812117.

  PMID: 10471636 BACKGROUND

• Zafar MA, Droege C, Foertsch M, Panos RJ. Update on ultra-long-acting beta agonists in chronic obstructive pulmonary disease. Expert Opin Investig Drugs. 2014 Dec;23(12):1687-701. doi: 10.1517/13543784.2014.942730. Epub 2014 Aug 19.

  PMID: 25139313 BACKGROUND

• Roskell NS, Anzueto A, Hamilton A, Disse B, Becker K. Once-daily long-acting beta-agonists for chronic obstructive pulmonary disease: an indirect comparison of olodaterol and indacaterol. Int J Chron Obstruct Pulmon Dis. 2014 Jul 31;9:813-24. doi: 10.2147/COPD.S59673. eCollection 2014.

  PMID: 25114521 BACKGROUND

• Cazzola M, Segreti A, Stirpe E, Puxeddu E, Ora J, Rogliani P, Matera MG. Effect of an additional dose of indacaterol in COPD patients under regular treatment with indacaterol. Respir Med. 2013 Jan;107(1):107-11. doi: 10.1016/j.rmed.2012.09.022. Epub 2012 Oct 18.

  PMID: 23083839 BACKGROUND

• Gabrijelcic J, Casas A, Rabinovich RA, Roca J, Barbera JA, Chung KF, Rodriguez-Roisin R. Formoterol protects against platelet-activating factor-induced effects in asthma. Eur Respir J. 2004 Jan;23(1):71-5. doi: 10.1183/09031936.03.00057803.

  PMID: 14738234 BACKGROUND

• Polverino E, Gomez FP, Manrique H, Soler N, Roca J, Barbera JA, Rodriguez-Roisin R. Gas exchange response to short-acting beta2-agonists in chronic obstructive pulmonary disease severe exacerbations. Am J Respir Crit Care Med. 2007 Aug 15;176(4):350-5. doi: 10.1164/rccm.200612-1864OC. Epub 2007 Apr 12.

  PMID: 17431221 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Blood Gas Analysis; Hydrogen-Ion Concentration; Cardiac Output; Respiratory Rate; Heart Rate; Blood Pressure; Oxygen; Carbon Dioxide; indacaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques; Chemical Phenomena; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Vital Signs; Physical Examination; Respiration; Respiratory Physiological Phenomena; Chalcogens; Elements; Inorganic Chemicals; Gases; Carbon Compounds, Inorganic; Oxides; Oxygen Compounds

Study Officials

• Isabel Blanco, MD, PhD

  Hospital Clínic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabel Blanco, MD, PhD

CONTACT

+34 649539835; IBLANCO2@clinic.ub.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 11, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 11, 2015

Record last verified: 2015-09

Locations

ES (1)