Exacerbation Prevention GOLD IV COPD With Non Invasive Mechanical Ventilation

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Exacerbation's Prevention in Patients With COPD in GOLD IV Stage (Very Severe) With Non Invasive Mechanical Ventilation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01481727
• Other study ID #: C-18-10NIRD
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 20, 2011
• Last updated: May 22, 2015
• Start date: December 2011
• Est. completion date: December 2015

Study information

• Verified date: May 2015
• Source: National Institute of Respiratory Diseases, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial 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.

Description:

Background:

• There are many previous studies (no controlled trials or observational studies)that demonstrated minimal benefits (on gas exchange and marginal effect over exacerbations frequency) with the use of non invasive mechanical ventilation, in BiPAP modality with IPAP pressures <18H2ocm (low intensity), in COPD patients.

• In subsequent years there were controled trials that concluded that there was no benefits with the use of non invasive mechanical ventilation on BiPAP mode in COPD patients ( It should be mentioned that in most trials were used low inspiratory pressure levels, that is called low-intensity non invasive mechanical ventilation).

• However, there are other recent studies that described some benefits of high intensity Bilevel modality of non invasive mechanical ventilation (inspiratory pressures >18cmH2O) specially on gas exchange, quality of life and functional status.

• There are some issues that do not yet have a clear answer like the optimal inspiratory pressure (IPAP) or the ventilation modality (BIPAP or other) to obtain the maximal benefit on COPD patients. Additionally, is not clear also if the use of non invasive mechanical ventilation on COPD patients helps to reduce the frequency and severity of acute exacerbations of COPD (AECOPD).

This study have some characteristics that are different to the previous reports:

• The inclusion of patients with frequent exacerbations phenotype (and therefore worst prognosis patients)that there are no included in previous trials

• The intervention maneuver that is bilevel modality of non invasive mechanical ventilation at hig-intensity pressure (>18H2Ocm and <24H2Ocm)

• The use of placebo maneuver (CPAP "Sham")

• The home titration in three phases, over a week

• The long-term use of the intervention and sham maneuver

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• BiPAP Pro 2, Phillips Respironics
mechanical ventilation type bilevel at high intensity (>18mmHg) for at least six hours, nocturnal ventilation.
• CPAP sham
CPAP sham maneuver (IPAP less or equal to 4cmH2O)

Locations

Country	Name	City	State
Mexico	National Institute of Respiratory Diseases	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Respiratory Diseases, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (8)

Budweiser S, Hitzl AP, Jörres 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. — View Citation

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. — View Citation

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. Erratum in: Eur Respir J. 2002 Dec;20(6):1617. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2009 Feb 27. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	lymphocyte subpopulations Th-1 and Th-17	It will be measured the lymphocyte subpopulations like Th-1 and Th-17	1 year	Yes
Secondary	six-minute walking test		1 year	No
Secondary	Forced expiratory volume in first second (FEV1) and forced expiratory capacity		1 year	No
Secondary	Maximal inspiratory pressure and maximal expiratory pressure		1 año	No
Secondary	gas exchange response (carbon and oxygen dioxide arterial pressure)		1 year	No
Secondary	Health related quality of life		one year	No
Secondary	anxiety and depression measures (HAD and Beck Questionnaires)		one year	No
Secondary	echocardiographic parameters		one year	No
Secondary	survival		one year	No
Secondary	IL-1 and IL-6 cytokines	it will be measured the level of interleukines 1 and 6(IL-1 and IL-6)	one year	No