Exacerbation Prevention GOLD IV COPD With Non Invasive Mechanical Ventilation

NCT01481727 | Unknown Phase 4

• 1 other identifier: C-18-10NIRD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy of high-intensity non invasive mechanical ventilation (during one year to reduce the severity and frequency of acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in patients with frequent AECOPD (frequent exacerbations defined more two or more AECOPD) and in GOLD IV stage (very severe COPD). The design is a randomised, double blind and controled with placebo (sham maneuver) clinical trial.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

acute exacerbation of COPD number; acute exacerbation of COPD severity

Outcome Measures

Primary Outcomes (2)

• acute exacerbations of Chronic Obstructive Pulmonary Disease frequency

  It will be calculated the exacerbation/year-patien rate and will be compared between groups

  1 year

• acute exacerbation of chronic obstructive pulmonary disease severity

  It will be measured the rate of AECOPD with hospitalary and Intensive Care Unity requirement

  1 year

Secondary Outcomes (10)

• lymphocyte subpopulations Th-1 and Th-17

  1 year

• six-minute walking test

  1 year

• Forced expiratory volume in first second (FEV1) and forced expiratory capacity

  1 year

• Maximal inspiratory pressure and maximal expiratory pressure

  1 año

• gas exchange response (carbon and oxygen dioxide arterial pressure)

  1 year

Study Arms (2)

cpap sham

PLACEBO COMPARATOR

non invasive mechanical ventilation type cpap sham manoeuver

Device: BiPAP Pro 2, Phillips Respironics; Device: CPAP sham

high-intensity NIMV

ACTIVE COMPARATOR

Non-invasive mechanical ventilation, biPAP modality, with high-intensity IPAP (\>18cmH2O)

Device: BiPAP Pro 2, Phillips Respironics

Interventions

BiPAP Pro 2, Phillips Respironics DEVICE

mechanical ventilation type bilevel at high intensity (\>18mmHg) for at least six hours, nocturnal ventilation.

Also known as: high intensity non invasive ventilation, high intensity bilevel

cpap sham; high-intensity NIMV

CPAP sham DEVICE

CPAP sham maneuver (IPAP less or equal to 4cmH2O)

Also known as: placebo CPAP, sham non invasive ventilation

cpap sham

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical and spirometric diagnosis for COPD (FEV1/FVC \<70%)
• Clinical phenotype of frequent exacerbations
• Must sign the informed consent
• Former smokers
• Stable COPD
• FEV1 \<35%
• Optimal medical treatment

You may not qualify if:

• OSAS diagnosis
• Other indications for non invasive mechanical ventilation
• Arterial pressure for dioxide carbon \>45mmHg
• Lung cancer
• Impossibility for doing spirometry or going to the medical visits
• Be included in another study

Sponsors & Collaborators

• National Institute of Respiratory Diseases, Mexico: lead

Study Sites (1)

National Institute of Respiratory Diseases

Mexico City, Mexico City, 14080, Mexico

Location

Related Publications (8)

• McEvoy RD, Pierce RJ, Hillman D, Esterman A, Ellis EE, Catcheside PG, O'Donoghue FJ, Barnes DJ, Grunstein RR; Australian trial of non-invasive Ventilation in Chronic Airflow Limitation (AVCAL) Study Group. Nocturnal non-invasive nasal ventilation in stable hypercapnic COPD: a randomised controlled trial. Thorax. 2009 Jul;64(7):561-6. doi: 10.1136/thx.2008.108274. Epub 2009 Feb 12.

  PMID: 19213769 BACKGROUND

• Clini E, Sturani C, Rossi A, Viaggi S, Corrado A, Donner CF, Ambrosino N; Rehabilitation and Chronic Care Study Group, Italian Association of Hospital Pulmonologists (AIPO). The Italian multicentre study on noninvasive ventilation in chronic obstructive pulmonary disease patients. Eur Respir J. 2002 Sep;20(3):529-38. doi: 10.1183/09031936.02.02162001.

  PMID: 12358325 BACKGROUND

• Casanova C, Celli BR, Tost L, Soriano E, Abreu J, Velasco V, Santolaria F. Long-term controlled trial of nocturnal nasal positive pressure ventilation in patients with severe COPD. Chest. 2000 Dec;118(6):1582-90. doi: 10.1378/chest.118.6.1582.

  PMID: 11115443 BACKGROUND

• Lin CC. Comparison between nocturnal nasal positive pressure ventilation combined with oxygen therapy and oxygen monotherapy in patients with severe COPD. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):353-8. doi: 10.1164/ajrccm.154.2.8756806.

  PMID: 8756806 BACKGROUND

• Windisch W, Haenel M, Storre JH, Dreher M. High-intensity non-invasive positive pressure ventilation for stable hypercapnic COPD. Int J Med Sci. 2009;6(2):72-6. doi: 10.7150/ijms.6.72. Epub 2009 Feb 27.

  PMID: 19277252 BACKGROUND

• Dreher M, Storre JH, Schmoor C, Windisch W. High-intensity versus low-intensity non-invasive ventilation in patients with stable hypercapnic COPD: a randomised crossover trial. Thorax. 2010 Apr;65(4):303-8. doi: 10.1136/thx.2009.124263.

  PMID: 20388753 BACKGROUND

• Windisch W, Kostic S, Dreher M, Virchow JC Jr, Sorichter S. Outcome of patients with stable COPD receiving controlled noninvasive positive pressure ventilation aimed at a maximal reduction of Pa(CO2). Chest. 2005 Aug;128(2):657-62. doi: 10.1378/chest.128.2.657.

  PMID: 16100151 BACKGROUND

• Budweiser S, Hitzl AP, Jorres RA, Heinemann F, Arzt M, Schroll S, Pfeifer M. Impact of noninvasive home ventilation on long-term survival in chronic hypercapnic COPD: a prospective observational study. Int J Clin Pract. 2007 Sep;61(9):1516-22. doi: 10.1111/j.1742-1241.2007.01427.x.

  PMID: 17686094 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• RAUL HUMBERTO SANSORES MARTINEZ, MMS and MD

  Instituto Nacional de Enfermedades Respiratorias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of COPD Clinic

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: November 29, 2011
• Study Start: December 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 25, 2015

Record last verified: 2015-05

Locations

ME (1)