Exacerbation Prevention GOLD IV COPD With Non Invasive Mechanical Ventilation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by National Institute of Respiratory Diseases, Mexico.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Alejandra Ramirez Venegas, National Institute of Respiratory Diseases, Mexico
ClinicalTrials.gov Identifier:
NCT01481727
First received: October 20, 2011
Last updated: May 8, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Device: BiPAP Pro 2, Phillips Respironics
Device: CPAP sham
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Exacerbation's Prevention in Patients With COPD in GOLD IV Stage (Very Severe) With Non Invasive Mechanical Ventilation

Resource links provided by NLM:


Further study details as provided by National Institute of Respiratory Diseases, Mexico:

Primary Outcome Measures:
  • acute exacerbations of Chronic Obstructive Pulmonary Disease frequency [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    It will be calculated the exacerbation/year-patien rate and will be compared between groups

  • acute exacerbation of chronic obstructive pulmonary disease severity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    It will be measured the rate of AECOPD with hospitalary and Intensive Care Unity requirement


Secondary Outcome Measures:
  • lymphocyte subpopulations Th-1 and Th-17 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    It will be measured the lymphocyte subpopulations like Th-1 and Th-17

  • six-minute walking test [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Forced expiratory volume in first second (FEV1) and forced expiratory capacity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Maximal inspiratory pressure and maximal expiratory pressure [ Time Frame: 1 año ] [ Designated as safety issue: No ]
  • gas exchange response (carbon and oxygen dioxide arterial pressure) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Health related quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
  • anxiety and depression measures (HAD and Beck Questionnaires) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • echocardiographic parameters [ Time Frame: one year ] [ Designated as safety issue: No ]
  • survival [ Time Frame: one year ] [ Designated as safety issue: No ]
  • IL-1 and IL-6 cytokines [ Time Frame: one year ] [ Designated as safety issue: No ]
    it will be measured the level of interleukines 1 and 6(IL-1 and IL-6)


Estimated Enrollment: 25
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481727

Contacts
Contact: MONICA VELAZQUEZ UNCAL, MD 52 55 54 87 17 00 ext 5166 movun77@yahoo.com

Locations
Mexico
National Institute of Respiratory Diseases Recruiting
Mexico City, Mexico, 14080
Principal Investigator: RAUL HUMBERTO SANSORES MARTINEZ, MSC and MD         
Sub-Investigator: Alejandra RAMIREZ VENEGAS, MMS and MD         
Sub-Investigator: OLIVER PEREZ BAUTISTA, MD         
Sub-Investigator: RAFAEL HERNANDEZ ZENTENO, MD         
Sub-Investigator: MONICA VELAZQUEZ UNCAL, MD         
Sponsors and Collaborators
National Institute of Respiratory Diseases, Mexico
Investigators
Principal Investigator: RAUL HUMBERTO SANSORES MARTINEZ, MMS and MD NATIONAL INSTITUTE OF RESPIRATORY DISEASES
  More Information

Publications:

Responsible Party: Alejandra Ramirez Venegas, Head of COPD Clinic, National Institute of Respiratory Diseases, Mexico
ClinicalTrials.gov Identifier: NCT01481727     History of Changes
Other Study ID Numbers: C-18-10NIRD
Study First Received: October 20, 2011
Last Updated: May 8, 2012
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by National Institute of Respiratory Diseases, Mexico:
acute exacerbation of COPD number
acute exacerbation of COPD severity

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014