Exacerbation Prevention GOLD IV COPD With Non Invasive Mechanical Ventilation

May 22, 2015 updated by: Alejandra Ramirez Venegas, National Institute of Respiratory Diseases, Mexico

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 14080
        • National Institute of Respiratory Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: cpap sham
non invasive mechanical ventilation type cpap sham manoeuver
Device: BiPAP Pro 2, Phillips Respironics
mechanical ventilation type bilevel at high intensity (>18mmHg) for at least six hours, nocturnal ventilation.
Other Names:
  • high intensity non invasive ventilation
  • high intensity bilevel
Device: CPAP sham
CPAP sham maneuver (IPAP less or equal to 4cmH2O)
Other Names:
  • placebo CPAP
  • sham non invasive ventilation
Active Comparator: high-intensity NIMV
Non-invasive mechanical ventilation, biPAP modality, with high-intensity IPAP (>18cmH2O)
Device: BiPAP Pro 2, Phillips Respironics
mechanical ventilation type bilevel at high intensity (>18mmHg) for at least six hours, nocturnal ventilation.
Other Names:
  • high intensity non invasive ventilation
  • high intensity bilevel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute exacerbations of Chronic Obstructive Pulmonary Disease frequency
Time Frame: 1 year
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
Time Frame: 1 year
It will be measured the rate of AECOPD with hospitalary and Intensive Care Unity requirement
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lymphocyte subpopulations Th-1 and Th-17
Time Frame: 1 year
It will be measured the lymphocyte subpopulations like Th-1 and Th-17
1 year
six-minute walking test
Time Frame: 1 year
1 year
Forced expiratory volume in first second (FEV1) and forced expiratory capacity
Time Frame: 1 year
1 year
Maximal inspiratory pressure and maximal expiratory pressure
Time Frame: 1 año
1 año
gas exchange response (carbon and oxygen dioxide arterial pressure)
Time Frame: 1 year
1 year
Health related quality of life
Time Frame: one year
one year
anxiety and depression measures (HAD and Beck Questionnaires)
Time Frame: one year
one year
echocardiographic parameters
Time Frame: one year
one year
survival
Time Frame: one year
one year
IL-1 and IL-6 cytokines
Time Frame: one year
it will be measured the level of interleukines 1 and 6(IL-1 and IL-6)
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Respiratory Diseases, Mexico

Investigators

  • Principal Investigator: RAUL HUMBERTO SANSORES MARTINEZ, MMS and MD, National Institute of Respiratory Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

March 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

October 20, 2011

First Submitted That Met QC Criteria

November 28, 2011

First Posted (Estimate)

November 29, 2011

Study Record Updates

Last Update Posted (Estimate)

May 25, 2015

Last Update Submitted That Met QC Criteria

May 22, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-18-10NIRD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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